International regulatory news in brief

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This post covers international regulatory news in brief. It is updated on an ad hoc basis.

For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab. Click on the respective tab to view the news for that region/topic.

UK
7 October
MHRA Corporate Plan 2023 to 2026 and Business Plan 2024/2025

MHRA has launched its corporate plan 2023/206 and business plan 2024/2025.

Tabulated below is a small selection of the key actions detailed in the plans in the plans.

Year/to be completed byKey actions
2024/25 (to be completed by 31 March 2025)Pilot the introduction of a single unified gateway to the MHRA through a new Customer Experience Centre knowledge hub, using automation and easy to access guidance to speed up access to information and enquiry response times. The hub launch will be completed by 31 Mar 2026.
Improve patient access by formalising new recognition pathways for UK approval that complement our national routes to market and that provide a legal base to allow for expedited access for some medicines and medical devices where these have already been approved by trusted regulators.
2025/26 (to be completed by 31 March 2026)Transform the regulation of generic medicines, building on defined criteria to meet evolving goals where regulator involvement adds most value, for example for sustainable medicines including green chemistry and reduction of plastics
Implement a revised regulatory framework for compliance, which is outcome-based and supports the implementation of our wider regulatory reforms such as the clinical trials framework and new provisions for point of care manufacture.

Source: MHRA

17 September
MHRA launches new Strategy for Improving Safety Communications: Improving information to patients and healthcare professionals

This World Patient Safety Day, 17 September 2024, the MHRA has launched a new three-year Strategy for Improving Safety Communications, which aims to transform the way it provides information about the risks and safety of medicines, medical devices and healthcare products in the UK to support effective implementation of new safety measures.

Source: MHRA

29 August
MHRA consultation on statutory fees – proposals on ongoing cost recovery

The MHRA is seeking views from interested stakeholders on proposals to update its statutory fees to ensure they continue to recover their costs.

Views are sought on the following proposals:  

  • Increasing the statutory fees shown in its consultation document to ensure continued cost-recovery until 2027. 
  • Amending the existing Medical Device Registration fee to include the costs for medical device post-market work.  
  • Creating a new service providing regulatory advice meetings for medical devices.  
  • Amending the fee model for three existing services, as well as increasing the fees to ensure continued cost-recovery until 2027, and also to remove 51 fees that are no longer in use.  
  • Updating and clarifying the legal definition of a “standard variation” application for homeopathic products. The “standard variation” application statutory fee for homeopathic products will be unchanged.

The implementation date for these proposed changes is April 2025.

You can respond to the consultation via this link.

Consultation start date: 29 August 2024

Consultation end date: 24 October 2024

Source: MHRA

Switzerland
1 October
Swissmedic changes the name of the “Public Summary SwissPAR” to “Short Report on Drug Authorization”

The “Public Summary SwissPAR” is now called “Brief Report on Drug Approval”.

  • The content of the drug approval summary report will not change and will continue to make Swissmedic’s approval decisions transparent and understandable to a broad audience.
  • The SwissPAR guidelines have been adapted accordingly.
  • The adapted SwissPAR guidelines come into force on October 1, 2024.

Source: Swissmedic

20 September
Go-live of the SwissGMDP database

Swissmedic is today launching the SwissGMDP database, which makes GMP and GDP certificates of all approved Swiss pharmaceutical companies publicly available.

  • This new platform improves the exchange of information between authorities, industry and the public.
  • The SwissGMDP is Swissmedic’s new database that lists all valid establishment license holders and their locations and provides electronic GMP or GDP certificates.
  • Stakeholders can quickly and easily check the validity and scope of an operating license, including locations, approved activities and GMP or GDP status.
  • The SwissGMDP replaces the previous table of authorisation holders on the Swissmedic website.

The SwissGMDP database offers:

  • Public access for all users
  • Free access to electronic GMP/GDP certificates
  • Access to GDP certificates from companies that only carry out GDP activities
  • Inclusion of Switzerland-specific activities
  • Creation of Excel lists based on specific search criteria or for all locations
  • Improving the exchange of information between regulators, industry and the public
  • Support in protecting the pharmaceutical and active substance supply chain by facilitating the verification of legitimate actors.

You can view the guidelines on the SwissGMDP database here (in German).

Source: Swissmedic

16 September
New regulatory law applies from 1 November 2024 – Ordinances of Human Research Act

The Federal Council has approved the amendments to the ordinances of the Human Research Act and adopted them on June 7, 2024.

  • The amendments strengthen the protection of people who participate in research and, where possible, improve the framework conditions for researchers.
  • With the amendments to the four ordinances to the HFG adopted on June 7, 2024, some improvements are being made and the requirements are being adapted to technological, scientific and social changes and to international developments.
  • The amended ordinances will come into force on 1 November 2024, with the exception of the provisions on transparency. These will come into force on 1 March 2025.

The provisional amending decrees to the following regulations and the corresponding explanations are available on the FOPH’s website “Legislative project: Revision of the HFG regulatory law” under the “Documents” tab:

  • Amendment to the Ordinance on Clinical Trials (KlinV)
  • Amendment to the Ordinance on Clinical Trials of Medical Devices (KlinV-Mep)
  • Amendment to the Human Research Ordinance (HFV)
  • Amendment to the Organisational Ordinance on the Human Research Act (OV-HFG)
  • Explanations on the changes to the regulations

The final amending decrees will be published in the Official Collection at a later date.

The full texts of the revised regulations will only be published in the Systematic Collection of Laws in the next few weeks.

Source: Swissmedic

1 September
Electronic data sets from pivotal bioequivalence studies

From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation.

  • This option is restricted to bioequivalence studies with a two-way, three-way or four-way crossover design.
  • Submission of these electronic data sets enables Swissmedic to analyse data effectively and efficiently using the latest state of science and technology.
  • Swissmedic does not require any additional data, but only recommends submitting the data in a standardised electronic format.
  • Submission is not mandatory and Swissmedic will continue to base its decisions on study reports in PDF format.
  • Section 6.5 Data sets relating to studies has accordingly been added to the form New authorisation of human medicinal products and section 6.5.2 Pharmacokinetic bridging has been revised in the guidance document Authorisation of human medicinal product with known active substance.
  • Further information on the technical requirements regarding data sets are set out in Annex 9.3 of the guidance document Authorisation of human medicinal product with known active substance.
  • The revised specification documents are valid as of 1 September 2024.

Source: Swissmedic

Mobile technologies – Submission of films as additional information regarding the safety, efficacy and quality of medicinal products
  • From 1 September 2024, Swissmedic will be accepting the submission of films as part of the authorisation of QR codes
  • The guidance document Mobile technologies stipulates the options for applying QR codes. The QR code can direct to a training/instructional film as additional information. In addition to the film script, the film can now also be uploaded directly via the portal with the application to apply a QR code.
  • The document Form Mobile technologies has been revised accordingly. See section 5.2
  • The revised specification document is valid with effect from 1 September 2024.
  • The technical requirements for transmitting the films are outlined in the linked publication Submission of accompanying documentation for applications for authorisation and variation for human medicinal products.

Source: Swissmedic

SEND data sets for new authorisation applications for human medicinal products with new active substances

From 1 September 2024, Swissmedic is accepting SEND (Standard for the Exchange of Nonclinical Data) data sets for applications for new authorisation for human medicinal products with new active substances.

  • SEND (Standard for the Exchange of Nonclinical Data) is a data format for preclinical studies that enables assessors, among others, to visualise the results of these studies.
  • The U.S. Food and Drug Administration (US FDA) requires the submission of SEND data for new authorisations according to their specifications in the Data Standards Catalog dated April 2024.
  • From 1 September 2024 data in SEND format can be submitted to Swissmedic for new authorisation applications for human medicinal products with new active substances.
  • This will be particularly useful for applications for which the preclinical data has already been produced in SEND format for submission to the US FDA. Swissmedic does not require any additional data.
  • Swissmedic will continue to base its decisions primarily on the underlying study reports in PDF format. However, the use of SEND data sets enables effective and efficient analysis of data according to the latest state of science and technology.
  • In connection with the new options for submitting electronic data, Section 6.5 Data sets relating to studies has been added to the form New authorisation of human medicinal products and section 5.2.4 Non-clinical documentation (Module 4) has been revised accordingly in the updated guidance document Authorisation of human medicinal product with new active substance.
  • Also available is a Form New authorisation of human medicinal products 

Source: Swissmedic

Combined studies: New forms and a new information sheet for submissions to Swissmedic

A clinical trial of medicinal products/advanced therapy medicinal products may be conducted in parallel with a clinical investigation of medical devices/an interventional performance study of in vitro diagnostics. In this case, requirements for the different types of research apply in full.


New forms and a new information sheet are now available to facilitate submissions to Swissmedic. Further information combined studies is available here.

Source: Swissmedic

Changes to the guidance document ‘Time limits for authorisation applications’

Following receipt of an application, Swissmedic checks the formal aspects of the application in the “Formal control and technical validation” phase.

  • If the documentation for the application is complete and formally correct, the application is formally accepted as valid (“Doc. OK” milestone). If there are formal shortcomings in the application documentation, however, Swissmedic sends a formal objection to the applicant.
  • Previously, written notification of achieving the “Doc. OK” milestone was given for applications for human medicinal products if there had been a prior formal objection.
  • In future, there will be no correspondence on achievement of the “Doc. OK” milestone.
  • Following a formal objection, the period stated in the guidance document Time limits for authorisation applications is available again to Swissmedic to recheck that the documentation is formally complete. After expiry of this time limit, the “Doc. OK” milestone is deemed to have been achieved.
  • For applicants using the Swissmedic Portal, completion of the “Doc. OK” milestone will continue to be visible in the Swissmedic Portal.
  • The guidance document Time limits for authorisation applications has been amended accordingly and other formal aspects have been revised.
  • The new practice and the revised guidance document Time limits for authorisation applications came into effect on 1 September 2024.

Source: Swissmedic

26 August
Responsible Person: requirements (I-SMI.TI.17e)

An updated of technical interpretation 17 ‘Responsible Person: requirements’ has been published.

  • For the inspectorates, to whom all technical interpretations are primarily addressed, the technical interpretation applies with immediate effect, as always in such cases.
  • Numerous clarifications have been made in the new version.
  • In most cases, compliance with the previous technical interpretation also guarantees compliance with the current version. In the few situations in which this is not the case, the licence holder is generally required to adapt immediately.
  • Chapter 5.5 requires a good knowledge of the local language for the responsible person.
  • Establishment licence holders whose already approved responsible person does not meet these requirements are given a period of 12 months from the date of publication of the updated technical interpretation to make the necessary adjustments, either by appointing a new responsible person with the required language skills or by ensuring that the responsible person acquires the required language skills within this period.

Source: Swissmedic

Turkey
20 September
Updated guidances on packaging Information published

Revision 13 of the following guidance documents has been published:

  • Guide on Packaging Information and Instructions for Use of Medicinal Products for Human Use,
  • Guide on Readability of Packaging Information and Instructions for Use of Medicinal Products for Human Use
  • Guide on Excipients in Packaging Information and Instructions for Use of Medicinal Products for Human Use

You can view/download the guidances here.

Source: TITCK

18 September
Guide on Classification of Variation Applications and Variation Applications

The Guide on Classification of Variation Applications and Variation Applications” prepared in order to decide whether an application is a variation or not, has been updated and published. You can view/download revision 5 of 17 September 2024 here.

Source: TITCK

4 September
Updated guideline on biosimilar products

The “Guideline on Biosimilar Medicinal Products”, which defines the concept of biosimilar medicinal products and determines the general principles to be applied in the licensing of these products, has been updated and published in line with administrative requirements and scientific developments. You can view Revision 3 of 2 Sept 2024 here.

Source: TITCK

29 August
Guideline on Scheduling Processes for Licensing Applications for Medicinal Products for Human Use

This guide which determines the procedures and principles regarding the scheduling processes for applications for human medicinal products that are deemed appropriate after a preliminary evaluation as a result of the examination carried out by the Agency among the human medicinal product licensing applications made to the Turkish Medicines and Medical Devices Agency, has been updated and published in line with administrative requirements.

You can view it here.

Source: TITCK

5 August
Uploading of corrected documents once deficiencies have been identified following first evaluation of licence application for Human Medicinal Products

Currently, for deficiencies identified in the first evaluation of the licence applications for Human Medicinal Products by the Preliminary Examination (CTD) Unit, all modules in the corrected application have to be uploaded to the system again from KİOSK.

  • From 8 August 2024, this will change so that only the PDF documents with the deficiencies must be uploaded from KİOSK.
  • Any PDF documents other than those notified in the deficiency letter must not be uploaded without being specified in the corrected application cover letter.

Source: TITCK

European Medicines Agency
2 October
Improving efficiency of the approval process for new medicines in the EU

EMA and the European medicines regulatory network (EMRN) are working to further improve efficiency in the assessment and approval processes for new medicines in the EU. The initiative aims to:

  • better manage the use of the network’s expert resources
  • streamline assessment processes
  • encourage more comprehensive application dossiers from marketing authorisation applicants at the time of initial submission.

One of the areas identified as needing improvement is the reliability of long-term planning for initial marketing authorisation applications (MAAs). This has been a recurrent problem for the network for many years, binding precious assessment resources and slowing down medicine approval times.

A multi-stakeholder workshop took place on Wednesday, 25 September 2024 to discuss submission predictability and how it can be improved.

  • A report with further recommendations to industry is under preparation and presentations from the workshop will be published.
  • Other ongoing measures that aim to ensure the sustainability of the EU regulatory network are:
    • Reinforcing best practices for requests for clock-stop extensions
    • Streamlined templates
    • Better guidance for assessors
    • Better predictability of post-marketing activities
    • Closer dialogue with applicants

More detail on each of the above is provided in this blog post.

Source: EMA

Ireland
1 October
Public consultation on proposed fees for 2025

The HPRA seeks comments on the annual review and proposal for fees 2025: Human Medicines, Compliance Activities, Blood, Tissue Establishments, Organs and Medical Devices.

The consultation is available to view on our Consultations webpage and replies are welcome from all stakeholders.

Any comments or questions on these proposals can be sent by email to feesconsultation@hpra.ie.

The outcome of the consultation will be published providing a general overview of the comments received and the changes made, if any, to the proposals.

Consultation start date: 1 October 2024

Consultation end date: 30 October 2024

Source: HPRA

26 September
HPRA medicinal Products Newsletter Issue 78 published

The above newsletter has been published and includes the following topics on human medicines:

  • Decentralised authorisation applications for 2025
    • The HPRA is available to act as a Reference Member State (RMS) for new Decentralised Procedure (DCP) applications in 2025, in particular for generic medicines and products with limited alternatives in Ireland.
    • Applicants planning to submit requests for DCP as RMS to the HPRA in 2025 should consult the new product applications page on the HPRA website.
  • Nitrosamines
    • The HPRA is reminding MA holders that they must maintain the quality of their product throughout its lifecycle.
    • Marketing authorisation holders must continue to review their risk evaluation on the presence of nitrosamines as new information becomes available.
    • This requirement is outlined in question 5 of the CMDh/EMA Q&A document on the CHMP opinion for Article 5(3) of Regulation (EC) No. 726.2004.
    • MA holders who previously submitted a ‘Step 2 nitrosamine detected’ template, resulting in a Scenario D outcome, are now required to carry out a calculation using the CPCA approach outlined in Appendix 2 of the Q&A.
    • This calculation determines the acceptable intake (AI) for that impurity. Marketing authorisation holders must then resubmit their Step 2 nitrosamine detected template to nitrosamines@hpra.ie indicating which of the resulting scenarios A, B or C apply.
  • Transfer before authorisation
    • Where a marketing authorisation is transferred before authorisation, the new holder must notify the HPRA using the procedure provided in the newsletter.
    • A transfer before authorisation must be submitted as a standalone application with all the required forms and supporting data. It is not acceptable to submit as part of the new application procedural documents.
  • CTR transition period – Deadline approaching
    • The HPRA would like to remind clinical trial sponsors of the following dates and deadlines in relation the Clinical Trials Regulation (CTR).
    • All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
    • Sponsors should submit transitions to CTIS by 16 October 2024 at the latest to permit review and authorisation.
    • An end of trial form should be completed to inform whether the clinical trial has been completed or never started.
    • Any trials authorised under the CTD which are ongoing after 31 January 2025 and have not transitioned to the CTR will not be compliant with the regulations for the conduct of clinical trials in Ireland.
  • Pre-CTA advice pilot
    • The HPRA is participating as a Member State Concerned in the ACT-EU preCTA advice pilot which is coordinated by the Clinical Trials Coordination Group (CTCG). It provides technical and regulatory support on the dossier of a CTA prior to its submission through the Clinical Trials Information System (CTIS).
    • The pre-CTA advice pilot will provide consolidated views of the Member States concerned on pre-submission topics.
    • The scope of this pilot covers several areas such as advice on regulatory aspects of low interventional clinical trial status and submission of trials with decentralised elements or complex designs.
    • More information on the ACT-EU pre-CTA advice pilot and how interested sponsors can apply is available in the pre-CTA advice pilot guidance for applicants.
  • Use of medicinal products containing estragole in the flavouring
    • The HPRA wishes to alert authorisation and registration holders to the use of flavours which may contain estragole. Estragole is a natural constituent of several aromatic plants and their essential oil fractions. Further detailed information is provided in the newsletter.

Source: HPRA

Spain
5 September
AEMPS enables a new procedure to present suergrouping for variations of medicines authorized by the national procedure

AEMPS has enabled a new procedure that establishes the possibility of submitting several modifications to marketing authorisations for medicines at the same time in a single application.

  • This procedure has been established in accordance with current regulations (Commission Regulation (EC) No 712/2012) and may be applied provided that the medicines are from the same authorisation holder (TAC) and have been authorised by a national procedure.
  • With its implementation, the AEMPS also eliminates the procedure for prior confirmation of the supergroup application proposal.
  • Companies wishing to use this procedure must verify and justify that they comply with the definition of supergrouping of variations and formally submit it to the Agency for acceptance once it has been evaluated.
  • All information about the requirements for applying for this procedure is available on the AEMPS website and in the instructions for applying for supergrouping of variations for medicines authorised by national procedure.
  • Supergrouping application proposals sent to the AEMPS that have not been confirmed must follow this new procedure.

Source: AEMPS

Italy
3 September
Two new AIFA guidelines

AIFA has approved the following two guidelines, providing clarifications with respect to the current European and national legislation and also adapting the Italian context to the EU Regulations.

  • Guidelines for the classification and conduct of observational studies
  • Guidelines for simplification and decentralization of clinical trials 

Source: AIFA

21 August
Guideline for the classification and conduct of observational studies on medicines

AIFA has published the Guideline for the classification and conduct of observational studies as part of the Italian legislation to comply with the requirements of Regulation (EU) no. 536/2014, which also includes specific provisions on observational studies, both profit and non-profit.

Pharmacological observational studies are particularly important for the evaluation of the safety profile in normal conditions of use and on large numbers of subjects, for in-depth analysis of the efficacy in real life conditions, on the use of medicines, for the verification of the appropriateness of prescription and for pharmaco-economic evaluations.

The new Guideline:

  • applies to all categories of observational pharmacological clinical studies and responds to the objective of providing clear and precise indications on their correct classification and on the operational aspects to be taken into particular consideration in the regulatory activities of conduct and evaluation by the Ethics Committees.
  • updates and replaces the previous one, issued with AIFA directorial decision of 20 March 2008 and which no longer adequately reflected the needs of a sector that has undergone significant technical-scientific evolution in recent years.

In drafting the new Guideline, AIFA has paid particular attention to these renewal needs, which also involve:

  • the regulatory framework by incorporating the innovations arising from Regulation (EU) no. 536/2014
  • the national adaptation legislation
  • the recommendations of the interested stakeholders and
  • the evolution of the scientific context.

Source: AIFA

USA
7 October
CDER Nitrosamine Impurity Acceptable Intake Limits

The following tables on this page have been updated most recently:

  • Table 1: FDA Recommended AI Limits for Certain Hypothetical NDSRIs and Other Identified Nitrosamine Impurities
  • Table 2: FDA Recommended AI Limits for Certain Nitrosamine Impurities
  • Table 5: Recommended Analytical Testing Methods

Source: FDA

27 September
Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program

On October 31, 2022, FDA first announced the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program for CBER and CDER regulated products.

  • CBER and CDER are continuing to conduct the CDRP to facilitate CMC development of selected products under investigational new drug (IND) applications with expedited clinical development timeframes to help patients get access to these products sooner.
  • Sponsors of INDs with accelerated clinical development timelines are invited to apply to the CDRP. 
  • On October 1, 2024, FDA will begin accepting requests from sponsors who wish to participate in year three of the CDRP.
  • Sponsors:
    • of INDs accepted into the pilot will be able to discuss their CMC product development strategies and goals with FDA review staff during two predesignated Type B meetings.
    • will have an opportunity for follow-up discussions to address questions arising from the meetings or when additional clarifications are needed.

Further information is available at the link below on how to apply.

Source: FDA

13 September
eCTD Submission Standards for eCTD v3.2.2 and Regional M1

There has been an update to the above on 9 September as follows:

Updates version of Lorenz tool, eCTD Technical Conformance Guide, and Comprehensive Table of Contents Headings and Hierarchy; adding Valid-Values.xml v6.0

Source: FDA

19 August
Submit an eCTD v4.0 or Standardized Data Sample to the FDA

FDA would like to assist sponsors and applicants who have not previously submitted in eCTD v4.0 and offers a process to validate sample new eCTD v4.0 submissions and standardized study datasets.

  • You must have an NDA, IND, BLA, ANDA, or MF number and plan to submit an actual submission to the FDA within 12 months of your sample request.
  • Sample submissions are not considered official submissions and are not reviewed by FDA reviewers at any time. 

When testing is complete, FDA will provide you with feedback, highlighting the errors found during the processing of the sample submission.

Source: FDA

16 August
eCTD Submission Standards for eCTD v4.0 and Regional M1

The tables the links below list all the documents and supportive files applicable to eCTD submissions to CDER and CBER.

Submission Standards for eCTD v4.0

Validation Tools and Electronic Submission Validation Criteria in Use

Source: FDA

Canada
13 September
Updated Policy on Drug/Medical Device Combination Products – Decisions

This policy been updated recently to correct an error although in the absence of any information, it is not possible to confirm exactly what the changes are.

Source: Health Canada

11 September 2024
Authorization for a third party to file a regulatory activity on behalf of the manufacturer/sponsor

You can view/download the updated form here.

Source: Health Canada

19 August
Updated: Guidance Document: Certificates of Supplementary Protection

An updated version of the guidance document with the above title was published on 19 August 2024 and is effective from that date.

The document has been updated to clarify that the patent expiry date is the date on which the term of the patent expires under section 44 of the Patent Act and clarify current practices, including the definition of “filing date”

You can view the view the updates on page 5 of the document.

Source: Health Canada

14 August
Notice – Release of the final guidance document: “Switching from prescription to non-prescription status”

Health Canada released the final version of the guidance document: “Switching from prescription to non-prescription status”.

This document replaces the guidance document “Data requirements for switching medicinal ingredients from prescription to non-prescription status” and comes into effect 60 days after its posting i.e. on 14 October 2024.

This new version of the guidance document:

  • outlines a new process for prescription to natural health product switches;
  • provides more in-depth guidance on data requirements for switches; and
  • introduces a new template to be included in all switch submissions.

Source: Health Canada

Brazil
3 October
New edition of Q& A on post-registration of synthetic medicines published

Anvisa has published version 5.1 (Oct 2024) of the Q & A document associated with Collegiate Board Resolution (RDC) 73/2016. The regulation provides for post-registration changes and cancellation of registration of medicines with synthetic and semi-synthetic active ingredients.

This edition includes changes to several questions and the addition of new questions and answers, as detailed here.

You can download the full document here.

Source: Anvisa

1 October
30 September
Anvisa and US FDA sign Confidentiality Agreement

Today, a mutual confidentiality agreement was signed between Anvisa and the US FDA.

  • The document was signed to facilitate the exchange of information on regulated medicines in pre-market and post-market phases.
  • The agreement allows the two agencies to share confidential and non-public commercial information about regulated drugs, both in  pre -market and post-market phases. 
  • The exchange of information with the FDA permitted by the new agreement, guarantees Anvisa access to strategic data on the safety, efficacy and quality of medicines already analyzed by the American agency, contributing to a more robust and agile evaluation in Brazil. 
  • This partnership brings direct benefits to the implementation of Anvisa’s Normative Instruction (IN) 289/2024, which deals with the criteria applied for the optimized analysis procedure.
  • The procedure in question uses assessments conducted by an equivalent foreign regulatory authority (AREE) to analyze registration and post-registration petitions for medicines, biological products, vaccines and letters of adequacy of the active pharmaceutical ingredient dossier (CADI FA ) in the national territory. 
  • IN 289/2024 focuses on:
    • accelerating the drug registration process
    • optimizing post-market supervision,
    • reducing deadlines
    • making the regulatory system more dynamic. 

Source: Anvisa

27 September
Anvisa publishes English version of IN 289/2024 and Q&A on regulatory trust

Regulatory trust is a concept widely discussed on the international stage and is part of regulatory convergence, which seeks to align national practices with global best practices.

  • This process involves a national regulatory authority (NRA) considering assessments carried out by another NRA or trusted institutions to support its own decisions.
  • This practice facilitates access to quality medicines, benefiting companies and consumers, in addition to optimizing the use of resources.

At Anvisa, regulatory confidence was included as a priority topic in the 2021/2023 and 2024/2025 Regulatory Agendas.

  • In 2022,  following following Public Consultation 1,108, the objective of which was to discuss the temporary application of regulatory confidence for the regularization of medicines and biological products IN 289/2024 was published  
  • IN 289/2024 aims to optimize the registration and post-registration analysis of medicines, biological products and vaccines in the country. This standard allows the assessments made by AREEs to be considered in the analysis carried out by Anvisa, ensuring the maintenance of quality, safety and efficacy standards in Brazil.
  •  Here, you can view the English version of Normative Instruction (IN) 289/2024.
  • The new Questions and Answers on the application of regulatory trust document published has been developed to clarify key questions about the use of regulatory trust, offering practical guidance to companies on how to present information and documents to facilitate the regulatory process.
  • The publication of these materials reinforces Anvisa’s commitment to promoting regulatory efficiency and accelerating access to essential medicines, always ensuring the safety and quality of the products available to the Brazilian population.

Source: Anvisa

25 September
Anvisa publishes panel with list of active ingredients of medicines awaiting registration

Anvisa has published a panel that allows users to consult the list of active ingredients of medicines with ongoing registration assessment by the Agency.

The tool includes the following product types:

  • generic
  • similar
  • specific, phytotherapeutic
  • dynamized, biological
  • radiopharmaceutical and
  • advanced therapy products.

From the panel, interested parties will be able to identify all active ingredients of medicines, by regulatory category and quantity, submitted for evaluation by Anvisa, with no decision yet published.

The panel will be updated monthly.

Click here to access the dashboard .

The consultation of already registered medicines remains available at https://consultas.anvisa.gov.br/#/medicamentos/ . 

Source: Anvisa

19 September
First Annual Report on Inspection Metrics in Good Clinical Practices published

Anvisa published its 1st Annual Report of Inspection Metrics in Good Clinical Practices (GCPs)  referring to the nine inspections carried out in 2023 by teams of inspectors in the area of ​​clinical research on medicines and biological products.

This is the first annual report of GCP indicators, whose main objective is to help professionals involved in the clinical research chain to increase adherence to good practices when conducting clinical research and preparing for inspection teams.

The inspections concluded that there is a strong commitment from sites and sponsors to conduct clinical research in accordance with GCPs, providing confidence in the quality of clinical trials conducted at these sites.

Source: Anvisa

13 September
Anvisa creates the Technical Chamber for Clinical Research on Medicines and Medical Devices (Catepec)

Joint Ordinance No. 2, of September 9, 2024 , was published today creating the Technical Chamber for Clinical Research on Medicines and Medical Devices (Catepec).

  • Catepec’s objective is to provide technical and scientific support to the Coordination of Clinical Research on Medicines and Biological Products (Copec/Dire2) and the Coordination of Clinical Research on Health Products (CPPRO/GGTPS/Dire3) of Anvisa, to fulfill their regulatory duties related to the processes of regulation and evaluation of clinical research on medicines and medical devices.
  • The chamber also aims to monitor scientific and technological developments in health surveillance, aiming to modernize, rationalize and streamline Anvisa’s regulatory action in the health control of clinical research, to subsidize the registration and post-registration of medicines and medical devices. 
  • The creation of Catepec is an integrated action to establish a consultative board specifically designed to work on clinical research. The board will be comprised of members with a range of technical knowledge, experience and skills relevant to the evaluation of clinical trial protocols to support the registration or post-registration of drugs and medical devices.
  • The technical support provided by Catepec will serve as a source of scientific evidence to improve the decision-making process within the technical areas and standardize the participation of external agents in the decision-making process related to clinical research for regulatory purposes. 

Source: Anvisa

29 August
Companies must submit a report on the marketing of medicines

From 2 September 2024, the Medicines Market Monitoring System (Sammed) will be available for sending marketing reports for the first half of 2024. 

  • Submissions can be made between September 2nd and 30th.
  • Reports sent after the deadline will not accepted.   
  • It is important to note that only companies that have submitted their Marketing Report to the Chamber for the Regulation of the Medicines Market (CMED), in accordance with Communiqué No. 11 of August 12, 2015, will be entitled to the maximum adjustment in drug prices in 2025.  
  • The report must be sent through the  Sammed system .
  • Guidelines for filling out and sending the report are available in the Marketing Report User Manual . 
  • Prior to submitting the report, it is important for companies to check all data to ensure that it is correct.
  • It is important to note that, according to CMED Resolution 2/2018, failure to submit the Marketing Report, or submitting it incompletely, inconsistently or after the deadline established by CMED, is considered a violation of the regulation of the pharmaceutical market.
  • Submitting incorrect data hinders the preparation of the Pharmaceutical Market Statistical Yearbook, as well as the market monitoring activities carried out by CMED.  

Source: Anvisa

13 August
New subject codes for registering biological products

From Monday 19th August, new subject codes will be made available for the registration of biological products.

  • The classification currently adopted considers the possible development and registration pathways: biological product and new biological product, development pathway by comparability and individual development pathway.
  • The new subjects however, will be specified according to the following categories: vaccines,
    • hyperimmune serums,
    • blood products,
    • biomedicines,
    • monoclonal antibodies,
    • live/attenuated/dead microorganisms,
    • industrialized allergenic products or
    • probiotics.

This new classification complies with the concepts and provisions of the standards that deal with the registration of biological products, namely: Collegiate Board Resolutions (RDCs) 55/2010, 187/2017, 194/2017 and 718/2022.

For better visualization, the change in codes on this page.

Source: Anvisa

5 August
Alert: increase in rejections of drug registration requests

Anvisa’s technical areas have identified deviations in registration requests in relation to

Both processes have directly impacted the increase in rejections of registration requests in Brazil.

Anvisa recommends that companies review their processes and procedures in order to adapt registration dossiers to current rules.

Source: Anvisa

11 July
Anvisa publishes SOP for the Medicines area

Anvisa has published a new standard operating procedure (SOP) for the Medicines area . 

  • Related to RDC 823/2023, the procedure provides risk-based guidelines to assess quality aspects in the registration and post-registration changes of synthetic and semi-synthetic medicines. 
  • The measure aims to reduce the number of requirements issued to companies seeking to regularize medicines.
  • It is estimated that the application of these new guidelines will result in a reduction of approximately 30% in the requirements carried out by the Agency’s Medicines area.
  • ANVISA is also developing similar procedures for other activities in the same area, which will be communicated in due course.
  • It should be noted that the document contains guidelines for employees to apply the new rules and is not subject to public consultation .   
  • You can view the procedure in full, via the Resolution 823/2023 page. The file is available in the “Related Documents ” section.

Source: Anvisa

10 July
Anvisa approves pilot project for digital leaflets for medicines

Anvisa directors approved, at the public meeting this Wednesday (10/7), a pilot project for the implementation of the drug package insert in Brazil.  

The project will be valid until December 31, 2026. The information collected and monitored during this period should serve as a subsidy for future definitive regulation on the subject.

The digital leaflet is an electronic version of the medication leaflet. It can be accessed by scanning a two-dimensional barcode (QR Code) on the packaging. The digital leaflet also allows access to additional information, such as videos, audios and other instructions that help with the proper use of the medication. 

Source: Anvisa

New Zealand
7 October
Guidelines on the Regulation of Therapeutic Products in New Zealand updated

Edition 7.2 (October 2024) of these guidelines has been published. The updates are as follows:

  • Editorial and formatting changes throughout for improved readability.
  • Section 2.13 and 2.14: Additional background information added to provide more context.
  • Section 2.5: Convention to follow if the product name for a generic medicine is composed of the INN, with the company (or other) name used as a separate identifier.
  • Section 2.6.1: Request that the full URL for the Medsafe/Centre for Adverse Reactions Monitoring (CARM) reporting form is used (ie, do not embed it).

Source: Medsafe

Australia
2 October
Updates to the Prescribing Medicines in Pregnancy database

In September 2024, TGA has updated its Prescribing Medicines in Pregnancy database,. You can view the updates at the link below.

Source: TGA

9 September
eCTD AU Module 1 v3.2 Summary of Changes

The purpose of this update from eCTD AU Module-1 v3.1 to eCTD AU Module-1 v3.2 is to:

  • Ensure alignment with current business processes and incorporate flexibility to adapt to future needs through revision of the defined lists and matrixes.
  • Support clear and consistent requirements through revision of the Australian eCTD validation criteria.
  • Provide efficient document locations within eCTD Applications through amendment of Module 1 heading elements.

This document applies to all regulatory activities submitted in electronic Common Technical Document (eCTD) format.

To allow for planning and software updates that the TGA has incorporated a transition period for the uptake of the AU Module 1 Version 3.2 specification.

  • The AU Module 1 Version 3.2 specification will be effective starting February 2025.
  • The AU Module 1 Version 3.1 specification will be accepted until August 2025.
  • Between February and August 2025, the TGA will accept both the Version 3.1 and Version 3.2 AU Module 1 specifications.

Further detailed information is also available at the link below.

Source: TGA

3 September
New approved forms for clinical trials

The following two forms (one of which appears to be a sub-section of a form) have been approved for clinical trials:

Form nameForm function
Approved form–clinical trial (form titled Clinical Trial Notification)This is the the approved form for notifying the Secretary of a clinical trial, and the therapeutic goods covered by the trial, is the online form titled Clinical Trial Notification, accessed via the Clinical Trial Notification item, under the Clinical Trials heading, within the Create Applications & Submissions section of the sponsor portal of TGA Business Services.
Approved form–additional trial site (Change to Trial Details section of the online form titled Clinical Trial Notification)This is the the approved form for notifying the Secretary of an additional trial site is the Change to Trial Details section of the online form titled Clinical Trial Notification, accessed by selecting ‘Vary’ in relation to the relevant clinical trial in the Clinical Trials Repository link, under the Your TGA Information heading, within the sponsor portal of TGA Business Services

Source: TGA

Malaysia
4 October
Applying for Data Exclusivity

Data exclusivity refers to protection of undisclosed, unpublished and non-public domain pharmaceutical test data, the origination of which involves a considerable effort, submitted as required to the Director of Pharmaceutical Services for the purpose of scientific assessment in consideration of the:

  • Quality, safety and efficacy of any new drug product containing a New Chemical Entity
  • Safety and efficacy for a second indication of a registered drug product as a condition for registration of any new drug product containing a New Chemical Entity; or approval for a Second Indication of a registered drug product.

An application for Data Exclusivity (DE) can be made via a Letter of Intent (LOI) in conjunction with the application for registration of a New drug product containing a New Chemical Entity or application for a Second Indication of a registered drug product.

  • The application must comply with all terms and conditions of the Directive: ARAHAN BAGI MELAKSANAKAN DATA EKSKLUSIVITI DI MALAYSIA; Bilangan 2 Tahun 2011.
  • The LOI should be addressed and submitted manually to the Director of the National Pharmaceutical Control Bureau.

Source: NPRA

19 September
Malaysian Guideline For Bioequivalence Inspection, Second Edition published

The second edition of the above guideline has been published. You can view the English edition here.

A decade has passed since the issuance of the first edition of the Malaysian Guideline for Bioequivalence Inspection in 2014. Since then, many processes related to the inspection of bioequivalence centres have been improved and updated.

  • This second edition serves to consolidate these improvements and updates to better guide the application and inspection process for bioequivalence centres to be listed on the NPRA Bioequivalence Centre Compliance Programme.
  • Building upon the foundation laid by its predecessor, this edition serves to provide more insight into the inspection application process, related fees, and scope of inspection.
  • The goal is to provide context and structure to the inspection process and enhance transparency while providing a comprehensive and contemporary framework that facilitates the inspection process.
  • It is hoped that this updated guideline will be able to provide the necessary guidance for the industry on matters related to the NPRA Programme and inspections of bioequivalence studies.

Source: NPRA

20 August
Product Classification Application Form update

An updated version (August 2024) of the Product Classification Application Form – NPRA/413/01-3 is now available for download here.

Source: NPRA

Pakistan
2 October
Switch over from Web Based One Customs (WEBOC) to Pakistan Single Window (PSW) for submission and issuance of all types Drug Import Licenses (DILs) and issuance of electronic release orders through PSW’s Single Declaration (SD) system.

PSW is an integrated Digital platform that allows parties involved in trade to lodge standardised information and documents with a single entry point to fulfill all import, export and transit related regulatory requirements.

  • Phase I of the DRAP-PSW was launched in February 2024 and currently, various processes related to the import and export of pharmaceuticals are live in the PSW system.
  • All the DRAP related commodities (Drugs) will be completely shifted over to PSW and clearance will be subjec to electronic issuance of Release Order by DRAP through the filing of a Single Declaration (SD) wioth effect from 8 October 2024 on all customs stations located in Peshawar and Islamadbad.

Further information is available here.

Source: DRAP

10 September
Minutes of 298th Meeting of the Central Licensing Board held on 26 July 2024

The following items are included in the minutes of the meeting:

1 Manufacturing requirements for Cephalosporin products

The Board discussed that the operations related to the manufacture, processing, and packing of cephalosporin should be performed in facilities segregated/separate from those used for other drug products for human use. This is due to their potential for causing allergic reactions.

  • Therefore, regarding new facilities, the Board has decided that cephalosporin shall only be manufactured, processed, and packed in separate and dedicated facilities.
  • The Board Authorized its chairman to issue the renewal of the Cephalosporin / Penicillin/ Penem Sections after receiving the undertaking for establishing a separate dedicated facility for Penicillin/cephalosporin/Carbapenem injectable within 2 years.

2 Establishment of A Registry of Technical Persons

The Central Licensing Board (CLB) of Drug Regulatory Authority of Pakistan (DRAP) has proposed the establishment of a registry of technical persons in the pharmaceutical industry, specifically focusing on production managers and Quality Control Managers.

  • The purpose of this registry is to facilitate the early approval of changes in technical personnel by providing a reliable database of qualified individuals in the field of pharmaceutical manufacturing in Pakistan.
  • The registry will be established through an online application system, where individuals with the required experience will be able to register themselves.
  • By maintaining a registry of technical persons, the CLB of DRAP aims to provide a centralized resource for the pharmaceutical industry.
  • This registry will enable companies to access a pool of qualified individuals, making it easier for them to recruit or find a suitable replacement for technical positions.
  • It will also help in regulating and monitoring the qualifications of technical personnel, ensuring the consistent quality of pharmaceuticals manufactured in Pakistan.

3 Late renewal Inspection for the renewal of the Drug Manufacturing License (DML)

The Central Licensing Board (CLB) has observed a significant delay in the conduct of inspections forthe renewal of the Drug Manufacturing License (DML).

  • This has resulted in a significant lapse of time without any inspection reports being received.
  • To address these concerns and ensure timely inspections, the CLB has implemented a new policy that requires all inspections to be conducted within six months after the constitution of the inspection panel.
  • This timeframe will ensure that the necessary inspections are undertaken promptly, minimizing any delays in the renewal of the DML.
  • The CLB also emphasizes that it is the responsibility of firms to cooperate fully and facilitate the inspection process.

Source: DRAP

2 September
Revision of Regulatory Fee Notification

DRAP has published a notification of fees update for 132 application types. You can view it here.

Source: DRAP

The Philippines
26 September
Administrative Order No.2024-0013 || General Rules and Regulations Pharmaceutical Products and Ingredients Intended for Human Use on the Registration of Active Pharmaceuticals

This order shall apply to all pharmaceutical products for human use and for which registration applications are submitted by eligible applicants as provided in section V.A.1. of this order to the FDA for the following authorisations:

  • Marketing Authorization
  • DoH-use-only Authorization
  • Foreign donation Authorization

This order shall also apply to APIs for human use intended for distribution and sale and submitted to the FDA for Marketing Authorization.

  • APIs manufactured or imported exclusively by the pharmaceutical product manufacturer for its production are not covered by this order.
  • Pharmaceutical products and APIs intended solely for export are not covered by this order.

Source: FDA

20 August
Administrative Order No. 2024-0012 – Prescribing the Rules and Regulations on the Registration o Pharmaceutical Products and Active Pharmaceutical Ingredients Intended Solely for Export

You can view the above order here. The annexes accompanying the order can be viewed via the link below.

Source: FDA, The Philippines

Singapore
25 September
Release of SG-HSA Specification Package v1.0 for eCTD Implementation

The Therapeutic Product Branch (TPB) is pleased to announce the release of the SG-HSA Specification version 1.0 package, effective 25 September 2024.

  • The eCTD Specification package version 1.0 is now available for industry stakeholders to prepare for test and actual eCTD submission in advance of the system rollout tentatively scheduled for March 2025.
  • This is an updated version of the previously published version 0.9 incorporating changes based on the feedback received during the industry consultation exercise held in May-June 2023.
  • The package comprises the following documents:
    • SG-HSA eCTD Specification and Validation criteria
    • Technical files (defined lists, validation matrices, stylesheets, schema)
    • Sample eCTD submissions
  • In addition to the eCTD Specification package, the following resources are available to guide industry stakeholders on the submission of eCTD package:
    • Updated Questions and Answers document
    • HSA Summary of Envelope Requirements

The above documents can be downloaded here.

A tabulated Summary of Changes to SG-HSA eCTD Specification package can be viewed at the link below.

Source: HSA

23 September
One stop digital portal for Class 2 CTGTP Registration launch imminent

On 7 October, the HSA will be launching ‘Share’, your one stop digital portal for Class 2  Cell, Tissue and Gene Therapy Products (CTGTP) Registration.

From 7 October 2024, log in to SHARE with your Corppass for the e-services below:

  • Apply/Amend/Cancel Product Registration
  • Submit Fulfilment of Approval Conditions
  • Change of Registrant
  • Update Business or Applicant Details
  • Track Application and Approval Status
India
24 September
Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Product, updated

Version 2.0 of the above guidance document has been published.

The changes to the document are as follows:

  • This guidance document is updated in the light of New Drugs and Clinical Trials Rules, 2019 and revised Schedule M of Drugs and Cosmetics Rules, 1945.
  • The terminology for PVOI is replaced with PVOIC.
  • The “Module” is replaced with “Chapter”
  • Definition of New Drug is updated in accordance with NDCT Rules, 2019
  • The Marketing Authorization Holders should maintain records in Excel/Electronic sheets.
  • All Non-Serious Adverse Events should be reported by MAHs within 90 calendar days.
  • The International Classification of Diseases (ICD) is replaced with MedDRA dictionary for coding of “Indication” during entry of Individual Case Safety Reports (ICSRs).
  • Appendix A – Simplified E2B Guide for Primary Reporters document id 01-15-006, Version 1.1 by WHO-UMC removed from this Guidance Document.
  • In Appendix E – PSUR Summary Report Checklist which was existing in previous version of this document has been removed
  • Frequently Asked Questions (FAQs) incorporated in Appendix E.

Source: CDSCO

7 August
Countries named under the Rule 101 of New Drugs and Clinical Trial Rules 2019 concerning new drug approvals

As per rule 101 of the New Drugs and Clinical Trials Rules 2019, CDSCO, with the approval of the central government may specify the name of countries from time to time, for consideration of waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under chapter 5 of said rules.

See letter of 7 August 2024 published with named countries here.

Source: CDSCO

Japan
6 September
Submitting documents in the application for approval of new ethical drugs, in English

PMDA has allowed until now, allowed CTD Parts 3, 4, and 5 listed in Section 3 of the Director’s Notification (“Guidelines for preparing documents to be attached to applications for approval of the manufacture or import of new drugs” (PSB/ED Notification No. 899 dated June 21, 2001 by the Director of PSB/ED, MHLW) to be submitted in English, in order to eliminate drug-lag/drug-loss and to make it easier for foreign companies to apply for marketing approval in Japan, it has temporarily decided, as a trial measure, to permit the submission of the entire application document in English.

Further information is available in the published administrative notice.

Source: PMDA

SAHPRA and TGA to share regulatory information and expertise
7 October

SAHPRA and TGA have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators.

  • The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered.
  • SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators.
  • This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns.

Source: SAHPRA

Ireland
11 October
FAQ on notification for in-house manufacturers of medical devices and in vitro diagnostic medical devices

This guide is intended to inform in-house manufacturers of the requirement to notify the Health Products Regulatory Authority (HPRA) of their activities and to provide clarity on the process and information to be provided.

Further information on the requirements for health institutions who manufacture and use in house IVDs is available on the HPRA website.

You can view the FAQ here.

Source: HPRA

India
8 October

Medical Device adverse event reporting form updated.

The medical device adverse event reporting form has been updated to version 1.2.

Source: CDSCO

3 October
India now an IMDRF affiliate member

To achieve global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry, and boost transnational prominence CDSCO applied for Affiliate Membership of the IMDRF in 2024.

After review of India’s application for Affiliate membership and meeting discussions by the IMDRF Management Committee (MC) with the senior officers of CDSCO during the 26thSession of IMDRF held in September 2024 at Seattle, Washington, USA, the CDSCO has received approval from IMDRF as an Affiliate Member of the Forum.

Source: gov.in

The Netherlands
8 October
Call to medical device manufacturers: implement an effective PMS system

The IGJ supervises post-market surveillance (PMS) at manufacturers of (in-vitro diagnostic) medical devices based in the Netherlands.

PMS refers to a range of activities that manufacturers must undertake in a coordinated manner to monitor the safety and performance of their devices. This process begins as soon as the product is launched and continues throughout its use. Since some products remain on the market for many years, it is crucial to ensure they still meet the required standards.

  • Since September 2023, the IGJ has intensified its supervision of PMS for manufacturers of (in-vitro diagnostic) medical devices based in the Netherlands.
  • The IGJ assesses a number of manufacturers specifically on their PMS practices.
  • For these inspections, the IGJ has developed a PMS assessment framework, which was published in September 2023.
  • This framework has been used by inspectors to evaluate how 13 manufacturers are executing PMS and ensuring its ongoing compliance.
  • The inspections focused primarily on micro, small, and medium-sized enterprises, covering Class I medical devices, software applications, and in-vitro diagnostics (IVDs) that are being marketed as legacydevices.
  • Legacy devices are medical products that, after the transition period, move into a higher risk category and require certification by a notified body.
  • The inspections focused on the PMS requirements that manufacturers must meet according to the MDR and IVDR.
  • The scope of the inspection was limited to evaluating the PMS plan, PMS reports, and the Periodic Safety Update Reports (PSURs) that must be prepared annually or biennially
  • None of the 13 manufacturers visited by the IGJ in 2023 and 2024 met the PMS requirements. You can read the document titled Call to medical device manufacturers: implement an effective PMS system for further detailed information.
  • The implementation of PMS was found to be inadequate at all 13 manufacturers visited in 2023 and 2024.
  • There was little to no difference in the number and type of non-compliances between the various categories of medical devices inspected.
  • Manufacturers perceive the PMS requirements from the MDR and IVDR to be complex.

Source: igj.nl

UK
26 September
Clinical investigations guidance for medical devices updated

According to the MHRA, the section of the guidance titled ‘Amendments’ has been updated to reflect changes to the process. No further information is provided.

Source: MHRA

19 September
Submission and approval of first application under the EU IVDR in Northern Ireland

The recent implementation of a submission route for manufacturers for performance studies has now enabled the submission and approval of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland.

  • This marks a significant milestone in the regulatory management of in vitro diagnostics within Northern Ireland, demonstrating a robust and efficient process for handling future applications.
  • This process was developed over the past eighteen months in collaboration with colleagues at  HSCNI and HRA.

Source: MHRA

6 September
Guidance updated: Notify MHRA about a clinical investigation for a medical device

This section Updated ‘In Vitro Diagnostic Medical Devices (IVDs)’ section of this guidance has guidance has been updated. No further specifics are provided.

Source: MHRA

5 August
Guidance updated: Notify MHRA about a clinical investigation for a medical device

This guidance has been updated with the addition of a new section Regulatory advice meetings added.

The MHRA Clinical investigations team can offer a comprehensive device regulatory advice meeting as well as provide guidance on navigating the regulatory landscape.

To request a regulatory advice meeting please contact the Head of clinical investigations – mark.grumbridge@mhra.gov.uk.

Source: MHRA

2 August
Guidance updated: Register medical devices to place on the market

This following sections of this guidance have been updated to to reflect changes to the registration system:

  • Account Management Reference Guide
  • Device Registration Reference Guide

Source: MHRA

Singapore
12 September
Good Submission Practice Workshop

The Medical Devices Cluster (MDC) conducted a Good Submission Practice Workshop on Wednesday, 28 August 2024.

  • The primary objective of this workshop was to emphasize the critical documentary requirements often overlooked during submissions.
  • The intention is to empower stakeholders to furnish good submission documents, thereby ensuring expedited processing or resolution of their applications.
  • The scope of submissions encompasses
    • Product Registration
    • Change Notification
    • Field Safety Corrective Action (FSCA)
    • Adverse Events and
    • Dealer’s Licence

For more information you can view the presentation slides here.

Source: HSA

Brazil
10 September
New standard on safety requirements for medical devices comes into force

On 4 September, Collegiate Board Resolution (RDC) 848/2024 (replacing RDC 546/2021) came into force.

  • It provides for the essential safety and performance requirements applicable to medical devices and in vitro diagnostic (IVD) medical devices.
  • It updates the information required to demonstrate the compliance of medical devices, with  in vitro diagnostic medical devices also being included in this new version .

According to the standard, products must meet the following requirements amongst others: 

  • be designed to meet the intended purpose, in accordance with the indicated conditions of use
  • be safe
  • function as intended by the manufacturer
  • have acceptable risks, considering the benefits;
  • must not compromise the clinical condition or patient safety.

The following must be supported by relevant clinical data obtained through an assessment of high-risk medical devices (classes III and IV) that verifies the existence of a favorable risk-benefit ratio based on scientific evidence.

  • The indication
  • intended use
  • performance and safety

The information must take into account the product life cycle and risk management.

The changes aim to ensure greater safety and effectiveness for medical devices and IVD medical devices, in line with the global scenario and technological and scientific developments.

Source: Anvisa

2 September
UDI-Anvisa Project (Unique Device  Identification)

In August, Anvisa met with companies participating in Pilot #1 of the UDI-Anvisa Project (Unique Device Identification). Companies had the opportunity to share their perceptions and contributions about the system being tested by the Agency.

Phase of ProjectDuration or completion Notes
Phase 1Completion due End Sept 2024This first version of the system will have the following basic features: access to the system, a web-based UDI data registration form, a query system (internal and external) with historical traceability, third-party user management and mass data registration (in XLM format – Extensible Markup Language ) by uploading files via the system interface.
Phase 2Oct 2024 – First half of 2025New functionalities will be implemented. The plan is to register UDI data in bulk from machine to machine, in addition to the functionality of mass registration by manual upload to the system, and to provide an API (application programming interface) for external queries, both using the HL7/FHIR communication standard.

Following completion of phase 1 of the project, the system will only be rolled out to the public after the publication of the normative instruction (IN) provided for in 
Collegiate Board Resolution (RDC) 591/2021 .

After the publication of the IN, the deadlines for the mandatory transmission of UDI data to Anvisa will begin, as defined in art. 15 of Collegiate Board Resolution (RDC) 591/2021 (amended by RDC 884/2024).
 

Source: Anvisa

28 August
Launch of new system module of e-Notivisa to report adverse events for medical devices

Anvisa will hold a webinar (aimed at companies and the public) on 2 September to present and launch the new e-Notivisa module.

  • The system will start receiving notifications of adverse events and technical complaints related to medical devices (health products).
  • With this new feature, citizens will have an even more efficient tool to report any incidents involving in vitro diagnostic products , medical-dental materials and equipment, among others.
  • The new module simplifies the reporting process, making it more intuitive and accessible, in addition to enabling companies to respond directly to citizens. 
  • The system also offers a more user-friendly interface and innovative technologies to automate the detection of signals and company responses through artificial intelligence mechanisms, intelligent searches and data science elements.
  • The new module joins the cosmetics, sanitizing and hygiene products modules, which are already fully operational. Learn more about e-Notivisa below.

Source: Anvisa

European Commission
13 August
UDI issuing entities update

Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewed the designations of the current four issuing entities for a further period of five years, until 27 June 2029.

See the UDI HRI & AIDC formats and basic UDI-DI formats used by each issuing entity via links on this page. This content is based on input from the issuing entities and will be regularly updated.

Source: European Commission

USA
1 August
Online resource for information on reprocessing of single-use medical devices

The FDA introduced online resources to provide information about reprocessing single-use medical devices for health care facilities and FAQs. The FDA remains dedicated to providing resources to help health care facilities establish, implement, or improve their quality assurance programs related to reprocessing single-use medical devices.

Source: FDA

European Medicines Agency
10 October
Public consultation on updated policy for handling of competing interests: revised rules for committee members and experts

The EMA is revising its policy on handling of competing interests of scientific committee members and experts (‘Policy 0044’). Stakeholders are invited to comment on the draft revised policy using an online questionnaire

  • The policy sets out the ground rules on which EMA involves experts in its work.
  • It has provided a robust framework for managing possible competing interests over many years, by applying restrictions to experts’ involvement in a proportionate manner, considering in particular the nature of the declared interest and the type of activity where the expert was involved (e.g. decision-making committees vs advisory bodies).
  • Recent court rulings (i.e. the appellate judgements of the Court of Justice in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 P) have required the Agency to adjust certain aspects of its approach.
  • The scope of the policy relates to the handling of competing interests of members, alternates and experts involved in the activities of the Agency’s scientific committees, working parties and other groups (e.g. scientific advisory groups (SAGs), ad hoc expert groups (AHEGs)) as well as other bodies (i.e. Emergency Task Force (ETF), Medicines Shortages Steering Group (MSSG), Medical Devices Shortages Steering Group (MDSSG)).
  • The proposed revisions to the policy ensure alignment with the Court’s findings and aim to rule out any possible doubts as to the objective impartiality of EMA’s assessments.
  • The adoption of the final version by EMA’s Management Board is expected by the end of the year.

The revision of the policy (see updated document here), in line with the findings of the recent court rulings, is driven by the following elements:

  • Any current interest in a product should lead to restrictions not only on the product concerned but also on products in the same declared condition;
  • Restrictions of an individual’s participation should apply not only to final deliberation and voting but also to discussions;
  • The handling of competing interests needs to be consistent across EMA activities (i.e. between committees and SAG/AHEGs) and across roles.

As a consequence, the main changes proposed to the policy include:

  • Increased and aligned restrictions across roles and groups for experts with a current interest in a product:
  • Aligned restrictions across roles and groups, in case of past employment in a pharmaceutical company, of a past consultancy or strategic advisory role and of past activity as (principal) investigator, with a unified three-year cooling-off period.
  • Strengthened handling of competing interests in the medical device industry, in light of EMA’s extended mandate in this area.
  • Introduction of new rules to handle certain interests in research organisations, for example in case of involvement in a unit that develops or manufactures medicinal products or medical devices or acts as a marketing authorisation applicant or holder for a medicinal product.
  • The revised policy continues to allow and further clarifies the use of the ‘expert witnesses’.

Consultation start date: 10 October 2024

Consultation end date: 10 November 2024

9 October
EMA and HMA consult on joint EU network strategy to 2028 

EMA and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 for an eight-week public consultation.

This is a review and update to the original five-year strategy, which was developed to cover the period 2021 to 2025 (EMANS 2025).

The strategic focus areas of the strategy to 2028, are as follows:

  • Accessibility – to facilitate pathways for access to medicines through healthcare systems in the EU.
  • Leveraging data, digitalisation and artificial intelligence – to improve decision-making, optimise processes and increase efficiency.
  • Regulatory science, innovation and competitiveness – to create a regulatory and research environment that improves innovation and competitiveness of the EU’s healthcare sector.
  • Antimicrobial resistance and other health threats – to prepare the EU for potential threats including antimicrobial resistance.
  • Availability and supply – to strengthen the availability of medicines to protect public and animal health.
  • Sustainability of the network – to ensure that the network has available resources to support its scientific and regulatory decision making.

Input on the draft strategy is welcome from all stakeholders via an online questionnaire.

Consultation start date: 9 October 2024

Consultation end date: 30 November 2024

Source: EMA

11 September
Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)

While co-processed excipients (CoPEs) can offer benefits such as improved functionality, they also introduce additional risks compared to using individual excipients.

The use of CoPEs in pharmaceutical formulations can present higher risks due to several factors: e.g.

  • complexity of composition (inherent variability, unpredictable interactions),
  • quality control (challenges for analytical methods, batch to batch consistency),
  • formulation development (complexity of optimisation studies,
  • challenges with scaling up production) and
  • stability issues due to combination of different materials.

These Q&As aim to harmonise and clarify dossier requirements for CoPEs using a risk-based approach; the Q&As are applicable to human and veterinary solid oral dosage forms.

Comments should be provided using this EUSurvey form.

Consultation start date: 11 September 2024

Consultation end date: 31 December 2024

Source: EMA

25 July
Guideline on the chemistry of active substances

This guideline replaces “Note for guidance on chemistry of new active substances” (CPMP/QWP/130/96, Rev 1) and “Chemistry of active substances” (3AQ5a).

The purpose of this guideline is to set out the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product.

  • The differences in requirements for new or existing active substances are clarified in the relevant paragraphs of the guideline where applicable.
  • For the purposes of this guideline, an existing active substance is one that has been used in a finished product authorised previously within the European Union.
  • This approach is consistent with the definition of new active substance in the Notice to Applicants, Volume 2A, Chapter 1, Annex I: a chemical (…) substance not previously authorised as a medicinal product in the European Union.
  • This guideline is not applicable to herbal, biological, biotechnological products, radiopharmaceuticals and radiolabelled products.
  • The guideline does not apply to contents of submissions during the clinical research stages of drug development.
  • Nevertheless, the development principles presented in this guideline are important to consider during the investigational stages.

Comments should be provided using this EUSurvey form.

Consultation start date: 25 July 2024

Consultation end date: 31 January 2025

Source: EMA

22 July
Draft Guideline on the Development and Manufacture of Oligonucleotides

This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic oligonucleotides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to active substance in solution, to medicinal product development, to oligonucleotide generics development, to oligonucleotide personalised medicine approaches and to clinical trial applications (human products only).

The purpose of this guideline is to set out the type of information required for the development, manufacture and control of synthetic oligonucleotides (existing or new chemical entities) used in a medicinal product, in the context of obtaining a marketing authorisation. There is also a chapter on the 70 requirements for clinical trial applications.

Comments should be provided using this EUSurvey form.

Consultation start date: 22 July 2024

Consultation end date: 31 January 2025

Source: EMA

12 April
Draft Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

This guideline is the 2nd revision of the CHMP Guideline formerly called “Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents”. It addresses the requirements for demonstration of therapeutic equivalence (TE) between orally inhaled products containing the same active moiety(ies).

Comments should be provided using this EUSurvey form.

Start of public consultation: 12 April 2024

End of public consultation: 30 October 2024

Source: EMA

Draft Guideline on the pharmaceutical quality of inhalation and nasal medicinal products

This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal 5 products (EMEA/CHMP/QWP/49313/2005 Corr).

The main aim of the first revision is to consolidate the information available in the previous guidance documents, the related published questions and answers, also taking into consideration recent advancements in the field, common practice and new regulations, including the medical device regulation.

Comments should be provided using this EUSurvey form.

Start of public consultation: 12 April 2024

End of public consultation: 31 October 2024

Source: EMA

European Commission
1 October
Public consultation: Implementing Regulation on joint scientific consultations on medicinal products for human use at Union level

Today, the European Commission launched an online public consultation on the draft implementing act on joint scientific consultations on medicinal products for human use at Union level under the Health Technology Assessment (HTA) Regulation.

The draft implementing act provides detailed procedural rules for the joint scientific consultations, covering:

  • the submission of requests from health technology developers;
  • the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts;
  • cooperation with the European Medicines Agency (EMA) where a health technology developer requests the joint scientific consultation to be carried out in parallel with EMA’s scientific advice process.

The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation.

Consultation start date: 1 October 2024

Consultation end date: 29 October 2024

Source: European Commission

The Philippines
24 September
Draft for Comments || Adoption and Implementation of the ASEAN Mutual Recognition Arrangement for Bioequivalence Study Reports of Generic Medicinal Products

This Order aims to officially adopt and implement the “ASEAN MRA for BE Study Reports of Generic Medicinal Products” to enable BE Study Reports issued by ASEAN-Listed BE Centres to be mutually recognized across Member States for review and assessment.

Specifically, this Order aims to provide general rules, regulations, and guidelines for BE Study Reports of covered generic pharmaceutical products and listing of BE Centres in the ASEAN.

All comments may be sent to cdrr.sds@fda.gov.ph using the comment form. The deadline for submission of comments is on or before 25 October 2024.

Source: FDA, The Philippines

Australia
12 September
Clarifying and strengthening the regulation of Artificial Intelligence (AI)

This consultation paper is seeking your feedback on identified areas for potential reform or refinement to address the risks and leverage the opportunities associated with the increasing use of AI models and systems in the pharmaceutical sector.. 

Your responses will help inform TGAs report to the Australian government which aims to:

  • Identify areas of TGAs legislative and regulatory framework where strengths currently exist and where potential changes could be considered to strengthen the mitigation of risks associated with AI models and systems.
  • Raise matters for consideration that are broader than the TGA’s responsibilities, legislation that is interconnected with AI in therapeutic goods and requires cross-agency consideration such as privacy, data security, and cybersecurity.
  • Emphasise the importance of international harmonisation being maintained as much as possible to assist access to products and export opportunities.

You can respond to the consultation here.

Consultation start date: 12 September 2024

Consultation end date: 13 October 2024

Source: TGA

New Zealand
22 August
Proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials

This consultation is aimed at the following:

  • pharmaceutical companies
  • health care professional organisations and individuals involved in conducting clinical trials in New Zealand.
  • people who participate in clinical trials or with an interest in clinical trials regulation

Medsafe is seeking your feedback on changes to the Guideline on the Regulation of Therapeutic Products in New Zealand: Part 11: Clinical trials – regulatory approval and good clinical practice requirements and two new guidance documents which are proposed to be used alongside the Guideline:

  • Considerations for First-In-Human (FIH) and Early Phase Clinical Trials; and
  • Clinical Trial Safety Monitoring and Reporting for Investigational Products (Medicines and Medical Devices).

Updates are proposed to:

  • Incorporate new or updated legislation and relevant guidance issued in New Zealand and overseas;
  • Reflect changes to best practice for the design and conduct of clinical trials (eg, patient involvement in study design); and
  • Provide more clarity to those involved in conducting clinical trials on their obligations.

You can access the relevant documents and respond to the consultation via the link below.

Consultation start date: 23 August 2024

Consultation end date: 27 October 2024

Source: Medsafe

Malaysia
7 August
Announcement to Product Registration Holders (PRHs): Revision of Categories and Criteria for New/Additional Indication Application – A Pilot Study

As the NPRA progresses towards implementing reliance throughout the product life cycle, it plans to expand the implementation of reliance to include new/additional indication applications beginning with a pilot project.

  • For this pilot project, the NPRA have revised the current categories and their criteria as in Appendix I. 
  • As this is a pilot project, the proposed estimated timeline for Additional Indication (AI) Full-reliance as detailed in Appendix I represents the best commitment NPRA can make under the current circumstances to test out new processes and requirements.
  • A checklist to be completed by applicants is also provided.
  • In addition to the AI applications, the NPRA is handling a high volume of variation applications, all with the same staff and resources.
  • NPRA is also working to streamline the variation process and seeks your assistance in properly planning and scheduling your variation submissions. This may help reduce the NPRA workload and consequently improve the timeline for new AI applications.

Pilot study start date: 1 August 2024

Pilot study end date: 31 July 2025

Source: NPRA

Canada
2 August
Consultation on draft guidance on expanded access clinical trials

Expanded access clinical trials, are investigations that can sometimes help to provide access to novel therapies before they have been authorized for sale by Health Canada. This could include therapies for serious or life-threatening conditions where authorized drugs may be limited for certain patients (for example, related to oncology, rare diseases and some mental health disorders).

  • Health Canada has developed a draft guidance document on expanded access clinical trials.
  • This draft guidance document explains the regulatory requirements for expanded access clinical trials. These requirements are supported by Part C, Division 5 of the regulations, entitled “Drugs for Clinical Trials Involving Human Subjects”.
  • Health Canada has authorized a number of expanded access clinical trials, including trials that are part of international, multi-site expanded access programs. However, the number of clinical trial sites opened and participants enrolled in Canada has been limited. This document provides additional information about how expanded access clinical trials are managed in Canada.
  • This draft guidance document is for
    • sponsors
    • health care providers
    • potential participants who are interested in, involved in or participating in expanded access clinical trials involving sites in Canada.
  • Health Canada is looking for your feedback on the draft guidance.

After the consultation period ends on October 31, 2024, Health Canada will review all written submissions. Your comments will be made public in a “what was heard” report and will be considered when the guidance is finalized. This final version will be developed as part of Health Canada’s broader clinical trial modernization initiative.

Consultation start date: 2 August 2024

Consultation end date: 31 October 2024

Source: Health Canada

24 July
Consultation: Release for Draft (Step 2) ICH Guideline, ICH M14

Please use the ICH template for public consultations to send in your comments.

Consultation start date: 24 July 2024

Consultation end date: 22 October 2024

Sources: Health Canada, ICH

Australia
28 August

Consultation: Draft Guidance – Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin

This guidance :

  • explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024.
  • helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.

covers the background, highlights key changes, and outlines the steps for sponsors and manufacturers to comply with the new requirements. Additionally, it provides examples to demonstrate how to apply the requirements in practice.

Your input is important to ensure the draft guidance outlines the background, key changes, and explains the steps for sponsors and manufacturers to comply with the new requirements.  

Your feedback will inform any changes to the guidance prior to publication on the TGA website. 

You can provide your feedback via this link.

Consultation start date: 28 August 2024

Consultation end date: 9 October 2024

Source: TGA

7 August
Consultation Australian Medical Device Essential Principles – Part 2: Proposed alignment with the European Regulation

The Australian (AUS) Essential Principles set out the safety and performance characteristics of medical devices in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.

This consultation seeks to confirm views, on where appropriate, the AUS Essential Principles should align with the GSPR of the European Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 for in vitro diagnostic medical devices (IVDR), collectively referred to as the EU Regulations.

There are two documents, the Consultation paper and Attachment 1 available at the bottom of this page. Please read both the documents and keep them available for reference when responding to the survey.

The consultation paper provides:

  • background and other information related to the consultation
  • all of the questions included in the online survey.

Attachment 1 includes:

  • each proposed change for the AUS Essential Principles
  • a legislative comparison between the AUS Essential Principles and the equivalent EU GSPRs.

You can respond to the consultation here.

Consultation start date: 7 August 2024

Consultation end date: 16 October 2024

Singapore
26 August
Consultation on Guidance on Change Management Program (CMP) for Software as a Medical Device (SaMD)

The Medical Devices Cluster (MDC) has released a draft of Guidance on Change Management Program (CMP) for SaMD for stakeholders’ consultation.

  • The document describes the regulatory requirements and procedures for CMP submission.
  • CMP is a new optional regulatory pathway specifically for SaMD that is incorporated into HSA’s Premarket Product Registration and Change Notification (CN) processes, which also introduces the concept of Pre-specified changes.

Stakeholders are invited to provide feedback on the Guidance on Change Management Program (CMP) for SaMD.

Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg. State “Feedback on Guidance on CMP for SaMD” in the email subject header.

Here, you can view Briefing webinar slides: Industry Briefing on CMP for SaMD_slides

Consultation start date: 26 August 2024

Consultation end date: 21 October 2024

Source: HSA

European Commission
1 August
European Commission – Survey on Electronic Instructions For Use (eIFUs) for medical devices

The European Commission is currently considering allowing the use of Electronic Instructions for Use for all professional use devices (i.e. devices that are used by healthcare professionals).

Healthcare professionals and or other persons working in or employed by a healthcare institution in the European Union are kindly requested to contribute to this survey. Your feedback will be essential to support the decision-making process of EU medical device regulators.

You can participate in the survey here.

Survey start date: 1 August 2024

Survey end date: 13 October 2024

Source: European Commission

European Medicines Agency
30 September
The use of Artificial Intelligence (AI) in the medicinal product lifecycle

The draft of this reflection paper was published in July 2023. The final version of the paper was adopted by the CHMP on 9 September 2024 and published by the EMA on 30 September 2024.

This reflection paper provides considerations on the use of AI/ML in the lifecycle of medicinal products, including the following:

  • medicinal products development
  • authorisation, and
  • post-authorisation.

Given the rapid development in this field, the aim of this reflection paper is to reflect on the principles that are relevant for regulatory evaluation when these emerging technologies are applied to support safe and effective development, manufacturing and use of medicines.

Further reading

EMA adopts reflection paper on the use of Artificial Intelligence (AI) By Jackie Mulryne et al on October 3, 2024 – Arnold & Porter

Source: EMA1, EMA 2

5 September
Harnessing the use AI via the use of large language models (LLMs) in medicines regulation

EMA and the HMA have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using large language models (LLMs) in their work.

  • The guiding principles cover various aspects of using LLMs, from ensuring safe input of data, to applying critical thinking and cross-checking outputs, to knowing whom to consult when concerns arise.
  • Additionally, the principles encourage regulatory agencies to make efforts to support their staff in using LLMs. This includes defining governance on the use of LLMs, specifying permitted use cases, providing training and monitoring risks.
  • The guiding principles:
    • are one of the deliverables of the multiannual AI workplan to 2028 by EMA and the Heads of Medicines Agencies (HMA). This workplan guides EMA and the EMRN in their use of AI, maximising the benefits while managing the risks, and facilitating information sharing.
    • are a living document that will be regularly updated, and EMA will introduce it to the network in a webinar on 13 September 2024. This is one of the various events and information sharing opportunities organised in the context of the AI workplan.

First international treaty to implement AI safeguards signed
5 September

The EU, UK, US and Israel have signed the first international treaty on artificial intelligence in a move that aims to prevent misuses of the technology, such as spreading misinformation or using biased data to make decisions.

  • The treaty, called the framework convention on artificial intelligence, was drawn up by the Council of Europe.
  • Under the legally binding agreement, signatories must implement safeguards against any threats posed by AI to human rights, democracy and the rule of law. 
  • The treaty states that AI systems must comply with a set of principles including: protecting personal data; non-discrimination; safe development; and human dignity

Source: The Guardian

Source: EMA

European AI Act
1 August

Today, the European Artificial Intelligence Act (AI Act), the world’s first comprehensive regulation on artificial intelligence, enters into force.

  • The AI Act is designed to ensure that AI developed and used in the EU is trustworthy, with safeguards to protect people’s fundamental rights.
  • The regulation aims to establish a harmonised internal market for AI in the EU, encouraging the uptake of this technology and creating a supportive environment for innovation and investment.

You can view a Q&A on AI here. and a webinar from Qserve on the impact of the EU AI Act on Medical Device and IVD Manufacturers here.

Sources: European Commission, Qserve

European AI Act published
12 July

Today, Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (the “AI Act”) was published in the Official Journal of the EU.

The AI Act will enter into force 20 days following its publication. It shall apply from 2 August 2026.

However:

(a) Chapters I and II shall apply from 2 February 2025;

(b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101;

(c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Source: huntoak.com

Brazil
8 October
SCMED publishes Yearbook with data on the national pharmaceutical market in 2023

he Executive Secretariat of the Chamber for the Regulation of the Pharmaceutical Market (SCMED) published the 7th edition of the Statistical Yearbook of the Pharmaceutical Market.

  • The objective of the Yearbook is to provide, in a rational and organized manner, statistics on the pharmaceutical industry in Brazil.
  • To outline the market profile, the survey considered consolidated data up to September 2024, extracted from the sales reports submitted by the companies.
  • The document provides a wide variety of information on the evolution of the pharmaceutical market, annual revenue, products sold, characteristics of medicines, distribution channels, most sold substances, among others.
  • The publication presents an overview of the national pharmaceutical market in 2023 and, this year, once again includes the  Statistical Annex , available in .xls format, which provides a detailed and comprehensive view of the data in this sector.
  • Designed to facilitate in-depth analysis of information, the Statistical Annex provides a comprehensive basis for exploring key market indicators and trends throughout the year, essential for a deeper understanding of industry trends and performance.

Source: Anvisa

US FDA
2 October

Are you interested in AI in supporting postmarket drug safety research? Check out this publication which discusses a novel AI tool created and validated by FDA that could enable researchers to efficiently identify and analyze safety-related drug labeling changes: https://lnkd.in/gjUi-RkY

The FDA envisions that the tool can increase efficiency for identifying safety-related labeling changes.

This tool is part of BERTox (https://lnkd.in/eUePjp8J), an initiative of the NCTR-developed AI4TOX  program (https://lnkd.in/esBC8WAi) that aims to apply the most advanced AI methods to develop new tools to support FDA regulatory science and strengthen the safety review of FDA-regulated products.

This research was conducted by authors George A. Neyarapally, Leihong Wu, Joshua Xu, Esther H. Zhou, Oanh Dang, Joann Lee, Dharmang Mehta, Rochelle D. Vaughn, Ellen Pinnow, and Hong Fang.

Source: FDA on LinkedIn

European Commission
12 September
The future of European competitiveness

This comprehensive report (commissioned by European Commission President Ursula von der Leyen) on the future of European competitiveness was published on 9 September. The report analyses the competitive landscape that the EU is facing and sets out proposals to improve Europe’s competitiveness. Section 9 on pages 187 – 199, dedicated to pharma is well worth reading.

The root causes of the EUs emerging competitive gap are listed as follows:

  1. Lesser and fragmented public R&D investment in the EU
  2. Lesser private R&D investment in the EU and a weaker supporting environment
  3. A slow and complex regulatory medicines framework in the EU which includes:
    • Approval times for new medicines in the EU/EEA under procedures performed by the European Medicines Agency (EMA) are longer than those of regulatory agencies in other regions
    • In addition, industry stakeholders report that compared to the US Food and Drug Administration (FDA), the EMA offers less opportunities for direct, structured interaction on scientific advice
    • Once a new medicine has been approved by the EMA, there are 27 different procedures to decide on national pricing and reimbursement
    • One critical element of these decisions is the national Health Technology Assessment (HTA), which commonly informs reimbursement decisions at the national level
  4. The complex emergence of a European Health Data Space (EHDS)

Amongst the proposals to address the key root causes driving the EU’s emerging competitiveness gap for pharmaceuticals are the following:

  1. Maximise the impact of the EU Health Data Space
  2. Streamline the set-up and management of multi-country trials in the EU
  3. Expedite access to markets

Source: European Commission

ICH

21 August
The ICH E11A Guideline Clinical Investigation of medicines in the paediatric population reaches Step 4 of the ICH Process

The E11A Guideline provides:

  • recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. The E11A Guideline 
  • a framework for using extrapolation to support paediatric drug development.
    • The framework describes an iterative process for understanding the existing information available, the gaps in information needed to inform development, and ways to generate additional information when required and recommends approaches to assessing factors that influence the determination of similarity of disease, drug pharmacology, and response to treatment between a reference and paediatric target population.
    • In addition, it discusses how the characteristics of the disease, drug pharmacology and response to treatment may influence this determination. 

Further information is available on this page.

Source: ICH