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.

Turkey
3 December
Regulation Amending the Regulation on Licensing of Human Medicinal Products

A regulation amending the Regulation on Licensing of Human Medicinal Products has been published. you can download it here.

Source: TITCK

20 November
Guidelines for Co-Marketed Medicinal Products for Human Use

The updated Guidelines for Co-Marketed Medicinal Products for Human Use (Rev 2 Nov 2024) which determine the principles and details for the licensing of jointly marketed products submitted to the Turkish Medicines and Medical Devices Agency and the definition of the requirements of licensed jointly marketed products, and for the license holder to fulfill their responsibilities regarding jointly marketed products, have been published.

Source: TITCK

11 November
Updated Guide on Cases Requiring Re-licensing of Licensed Human Medicinal Products

The “Guide on Cases Requiring Re-licensing of Licensed Human Medicinal Products”, which determines the principles and details regarding the license transfer, lost license arrangement and transition to certified license of licensed human medicinal products in accordance with the “Regulation on Licensing of Human Medicinal Products” numbered 31686, has been updated (Rev 2 of Nov 2024) and published with four Annexes.

Source: TITCK

8 November

Currently, a “Drug Distribution Document” showing the market status of drugs is issued by the Information Systems Department of TITCK upon application bypharmaceutical license holder companies.

In line with the arrangements made, from now on, the application requests made by the pharmaceutical licence holder companies in the ‘Drug Distribution Certificate’ document type will be accrued per document and it will be possible to apply for more than one drug in one document.

Source: TITCK

Switzerland
1 December

In clinical trials with drugs in the early stages of development (ie first use in humans, early Phase I studies), new test substances are used on humans for the first time.

  • Initial findings on their tolerability and safety are collected.
  • In order to ensure the best possible protection for the test participants, special aspects must be taken into account by the sponsors and the participating clinical trial centers when planning and conducting such trials, which Swissmedic and swissethics have summarized in a position paper.

Source: Swissmedic

1 November
Clinical trials: Revised implementing regulations of the Human Research Act

The amended ordinances relating to the Human Research Act enter into force today.

The important dates are listed in the table below:

DateEvent
7 June 2024The Federal Council approved the amendments to the ordinances relating to the Human Research Act and adopted them. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers
1 November 2024The amended ordinances enter into force on 1 November 2024 with the exception of the provisions on transparency,
1 March 2024The exception of the provisions on transparency enter into force.

This page, which is continually updated, provides information about the practical procedure for submitting applications for clinical trials with medicinal products to Swissmedic before and after the ordinances relating to the Human Research Act come into force.

Source: Swissmedic

15 October
Changes to the guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

The processes for the following have been optimised:

  • applying for the implementation of a fast-track authorisation procedure (FTP) or
  • the implementation of temporary authorisation / temporary additional indication (temp.auth. / temp.AI)

Normally, if the criteria for an FTP or a temp.auth. / temp.AI cannot be conclusively evaluated following the assessment of the submitted documents by Swissmedic, an Accelerated Application HeAring (AAA) usually takes place.

  • Swissmedic can now dispense with the implementation of an AAA if the additional documents submitted by the applicant for the scheduled AAA show that all of the criteria for the requested authorisation procedure are fulfilled.
  • In this case, Swissmedic will issue an official decision to approve the request for the implementation of an FTP or temp.auth. / temp.AI.
  • The submission date for the authorisation application has also been clarified.
  • Provided the application procedure for the implementation of an FTP or temp.auth. / temp.AI is approved, the applicant can submit the authorisation application on the date stated on the decision minutes.
  • If, after receiving a positive ruling on the requested authorisation procedure, the applicant would like to submit the authorisation application on an earlier date, the applicant can contact Swissmedic in order to check whether earlier submission is possible.
  • Swissmedic has updated the guidance documents Fast-track authorisation procedure / Temporary authorisation for human medicinal products accordingly.
  • These documents took effect on 15 October 2024.

Source: Swissmedic

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

UK
15 November
Guidance updated – How Marketing Authorisation Applications referred under Article 29 are handled

Article 29 of Directive 2001/83/EC provides for referrals that are triggered when a consensus cannot be reached between EU Member States on the outcome for a Marketing Authorisation Application (MAA) which has been evaluated in a mutual-recognition procedure (MRP) or decentralised procedure (DCP), on the grounds of a potential serious risk(s) to public health (PSRPH).

  • All sections of the guidance have been updated Updated all sections for clarity and deletion of Brexit information 
  • Section 2 – Has been with respect to the Windsor Framework medicines arrangements following implementation   on 1 Jan 2025
  • Section 3 – The contact information has been updated.

Source: MHRA

31 October
Guidance updated: MHRA phase I accreditation scheme

The document entitled Request for acceptance as a phase I principal investigator for first in human trials associated with this guidance has been updated.

Source: MHRA

25 October
Clinical investigations guidance

MHRA has updated its guidance with the addition of the ‘IRAS User Guide – Amendments‘.

SOurce: MHRA

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

Ireland
6 November
Outcome of the Process – Public Consultation on proposed fees for Human Medicines, Compliance, Medical Devices and Veterinary Medicines for 2025

The public consultations on proposed fees 2025 for Human Medicines, Medical Device and Compliance fees and Veterinary Medicines fees closed on 30 October 2024.

You can view the outcome of the process here.

The HPRA has reviewed and considered the above responses. In relation to the comment from the medicines industry representative, the HPRA has made the appropriate change to the fee.

Response Regarding comments from human medicines MA holder

  • Regarding the comments received from the human medicines marketing authorisation holder, the HPRA acknowledges the company’s concerns on the proposed increase to the clinical trial fees and recognise the importance of supporting clinical trials in Ireland.
  • The basis for the increase was to reflect the impact of the clinical trials regulation (CTR) and to bring HPRA fees in line with similar agencies in Europe.
  • However, in recognition of the concerns expressed, HPRA revisited the fee proposal and consequently have reduced the proposed increase from 15% to 10%.

Response in relation to comments on the proposed general increase on fees

  • In relation to the comment on the proposed general increase, the HPRA increased the fees in 2024 by 1.5% which combined with the proposed 5% for 2025 equates to 3.25% over the two 1/2 Outcome of the Process – Public Consultation on Proposed Human and Veterinary Medicines and Compliance Fees for 2025 years which is significantly less than the combined payroll and inflationary increases.
  • The HPRA funds the authorisation of medicines without exchequer funding and is therefore required to cover its costs. While we appreciate that increased fees impact stakeholders, the HPRA needs to cover the increases to its costs so that it can continue to deliver both its public service remit and the service industry requires. Consequently the HPRA will be maintaining the proposed increase to the fees of 5%.

Response to other considerations not identified as part of the consultation process

Although not identified as part of the consultation process, in light of the end of the Brexit exemptions and the introduction of the Windsor Framework, and based on comments received from industry, the HPRA have proposed not to add any increase to the annual fee for dormant authorisations to help maintain those authorisations.

Source: HPRA

17 October
Guide to Batch-Specific Requests for Human Medicines

This document has been updated. here, you can view the track changed (13 Oct 2022) and clean (17 Oct 2024 ) versions. The bulk of the changes are in Appendix I SAMPLE BATCH-SPECIFIC REQUEST CAUTION-IN-USE LETTER and thereafter.

  • Batch-specific requests (BSR) are accepted for critical medicines which hold a marketing authorisation (MA) issued by the Health Products Regulatory Authority (HPRA) or by the European Commission, to bring a batch of product into compliance with its marketing authorisation to ensure maintenance of supply.
  • In some instances, a BSR may be accepted for non-critical nationally authorised (including herbal and homeopathic products) products in order to correct a quality defect or to bring a batch into compliance with its registered MA dossier.

Source: HPRA

16 October
Application Form A for Transfer of an Authorised (Parallel) or Dual Pack Import Registration (DPR) Product

You can download version 11 of this form here.

Source: HPRA

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

European Commission
16 October
Update – Notified bodies overview (15 October 2024)

You can download the update here.

Source: European Commission

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

Canada
18 November
Change in filing requirements for the extensible markup language product monograph (XML PM): Notice

Health Canada is announcing the first phase of the mandatory use of the extensible markup language product monograph (XML PM).

  • In this first phase, a subset of submission types will be required to include the XML PM at the time of filing.
  • Health Canada will inform you when it expands the scope to other submission types.
  • As of 18 July 2025, when the first phase takes effect, the XML PM will be a mandatory filing requirement for:
  • new drug submissions (NDS)
  • extraordinary use new drug submission (EUNDS)

Further information is available at the ink below.

Source: Health Canada

USA
28 October
CDER Nitrosamine Impurity Acceptable Intake Limits

The following changes have been made

  • Table 1: FDA Recommended AI Limits for Certain Hypothetical NDSRIs and Other Identified Nitrosamine Impurities has been updated
  • Information on Ritonavir has been added to Emerging Issues section 

The changes to the table are described at the end of the page at the link below.

Source: FDA

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

Brazil
3 December
Anvisa launches new legislation portal, AnvisaLegis

On 2 December, Anvisa launched its new legislation portal, AnvisaLegis.

The portal brings together the Agency’s set of regulatory standards and all other publications of the regulatory process, such as:

  • public consultations,
  • guides,
  • regulatory impact analysis reports

Note that the portal extends well beyond pharmaceuticals. It seems easily accessible and well laid out. If you click on the topic ‘Guides’ and then on ‘Topic guides’ you can find regulatory guidance documents applicable to the pharmaceutical industry.

Source: Anvisa

28 November
Anvisa approves new framework for clinical research rules in the country

Anvisa recently approved a broad update of the standard that regulates clinical research in Brazil. The new rules should allow Brazil to become more attractive for investments in clinical research.

Some of the main new features of the standard are:

  • Possibility of bringing forward the import of investigational drugs for research while the dossier is being analyzed. This measure will allow for a shorter time between the authorization of the research by Anvisa and the effective start of a clinical study.
  • Regulation of the use of continuous submission in clinical research. This mechanism will allow researchers to submit data for approval of a research study in stages, as these data are produced, which will allow Anvisa to start evaluating applications earlier, while the other data and information are generated.
  • Introduction of more precise definitions for risk categories, study phases and technical requirements. The IN will bring clear criteria for classifying the risk and complexity of clinical trials and experimental drugs and the definition of Equivalent Foreign Regulatory Authorities (AREEs), aiming at the optimized analysis of petitions and the reduction of duplication of analysis.
  • Harmonization of national regulatory practices with standards recommended by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), notably the ICH E6(R2) Good Clinical Practice Guide.

Source: Anvisa

21 November
Anvisa publishes dashboards on Letter of Adequacy of Active Pharmaceutical Ingredient Dossier

Two dashboards with information about the Active Pharmaceutical Ingredient Dossier Adequacy Letter (Cadifa) are now available.

  • The first dashboard  Cadifa panel was developed to consult and monitor the issuance of the Cadifa. Through it, it is possible to check the valid version of the Letter or whether it is suspended or cancelled.
  • The dashboard displays data such as the holder of the Cadifa, the active pharmaceutical ingredient (API), the Letter number, the last review and whether the review is valid. The information disclosed is aligned with the practices of reference authorities, which have a similar regulatory model for the sanitary control of API.
  • The second dashboard Cadifa notification queue linked to post-registration  offers interested parties the possibility of carrying out searches on the distribution order for Cadifa analysis related to post-registration petitions.
  • The search can be conducted in several ways, including searching by case number, regulatory category and post-registration status, as well as by notification case number. 
  • The dashboards reflect Anvisa’s commitment to public transparency in the flow of analysis of drug registration, in accordance with the Access to Information Law (Law 12,527, of November 18, 2011).

Source: Anvisa

13 November
Changes to subject codes for biological product registration processes have been initiated

New subject codes for the registration of biological products have been 
available since 19 August 2024. 

  • The new codes are the result of the separation of the previously valid subjects and now detail the different categories of biological products .
  • The new classification adopted considers the possible development and registration pathways (biological product and new biological product, development pathway by comparability and individual development pathway ) . 
  • The different  categories of products subject to regularization  are also considered  e.g.:
    • vaccines,
    • hyperimmune serums  
    • blood products 
    • biomedicines  
    • monoclonal antibodies
    • live/attenuated/dead microorganisms.
  • This classification complies with the concepts and provisions of the standards that deal with the registration of biological products: Collegiate Board Resolutions (RDCs) No. 55/2010 , No. 914/2024 , No. 915/2024 and No. 718/2022 . 
  • ANVISA is gradually adapting the registration processes filed before this change. No action is required on the part of companies. 
  • Even applications that have already been completed will have their subject code amended, thus seeking to bring better quality to historical data for each category and improving the understanding of deadlines and difficulties for each type of product . 
  • The subject code for some products will remain unaltered, especially for certain molecules that in the past could be registered by a modality that does not have a corresponding current model.

Source: Anvisa

9 November
Anvisa signs agreement with Brazilian Agency for Industrial Development (ABDI) to modernize systems

Anvisa and ABDI have signed a technical cooperation agreement aimed at modernizing the regulatory agency’s information systems.

  • The main objective of the two institutions with this agreement is to enable investment in information technology (IT) tools capable of optimizing Anvisa’s performance, promoting automation and reducing dependence on qualified labor for minimum data structuring, which should allow for an acceleration in the decision-making process.
  • The partnership should enable the modernization of Anvisa’s technology park and the improvement of its internal processes, in order to meet the deadlines set forth in the legislation.
  • One of the expected effects is the increase in competitiveness and innovation in the Brazilian pharmaceutical sector, especially due to the adoption of information standards already used by the main drug regulatory agencies in the world.
  • The implementation of the eCTD which allows the submission of drug applications in the format used by the world’s leading drug regulatory agencies, is seen as a priority for the pharmaceutical sector.
  • To this end, one of the actions that Anvisa needs to develop is the adoption of international standards, such as the  Identification of Medicinal Products (IDMP) and  HL7 FHIR, which ensure better data structuring, interoperability and efficient exchange of information between healthcare systems and regulatory authorities in different countries.

Source: Anvisa

8 November
Anvisa adopts artificial intelligence strategy in drug analysis

As part of its commitment and ongoing effort to provide quality and efficient services, Anvisa has adopted several strategies to optimize its work processes. Among the strategies to use of technological solutions is the application of artificial intelligence (AI) models.

  • The Agency developed an AI-based tool to optimize the analysis of qualification studies of impurity limits and degradation products in synthetic drugs, classified as new, innovative, generic and similar.
  • The qualification analysis of impurities and degradation products is an integral part of the safety analysis within the scope of the registration and post-registration of medicines.
  • The activity is mandatory when the limits found in the products are higher than the limits established by the standard (RDC 53/2015), by international guides on the subject and by the Pharmacopoeias recognized by Anvisa.
  • When this happens, companies are required to provide data that supports safe limits for each of the impurities present in the medicine.
  • Considering that some impurities can be repeated in different medicines, the technological solution developed by the Agency allows the use of prior knowledge in the analysis of impurity qualification.
  • In this way, the application of the tool will allow for the even faster identification of impurities identical to those whose safety has already been analyzed previously.
  • In addition to identification, the tool will enable the grouping and systematization of data on impurities, offering information in a more structured manner to assist Anvisa in decision-making.

Source: Anvisa

25 October
OTC drugs: Anvisa changes subject codes for classification requests

Anvisa has made changes to the petition regarding the change in prescription restrictions for medicines.

  • The measure includes the classification of the medicine as an over-the-counter medicine (OTC) and the reclassification as a prescription medicine.
  • These changes include a change in the petition subject codes, to organize requests according to the different regulatory categories that are eligible for MIP classification, according to the Collegiate Board Resolution (RDC) 882/2023. 
  • The new subject codes will be available starting 29 October.
  • The change covers requests for classification as MIP or reclassification under prescription for medicines categorized as generic, similar, new, innovative, specific, phytotherapeutic and biological products.
  • Previously, all categories could have requests submitted using the subject code “11190 – Request for classification of a drug as non-prescription or reclassification under prescription”. Now, this code should only be used for drugs classified as generic, similar, new and innovative.
  • To facilitate requests for medicines classified as biological products, a new subject code 12357 was created.
  • Therefore, companies must select the subject code corresponding to the regulatory category of the drug that is the subject of the request, as stated in the table below.
Regulatory categorySubject codeSubject description
Generic, similar, new and innovative11190Gesef – Request for classification of a medicine as non-prescription or reclassification as prescription
Biological products12357GPBIO – Request for classification of a drug as non-prescription or reclassification as prescription

Source: Anvisa

21 October
Clinical trials with advanced therapy products have new subject codes

Anvisa has implemented a new list of subject codes for primary petitions for clinical trials with experimental advanced therapy products (ATPs) under clinical investigation.

  • Subject codes are organizational mechanisms of the Datavisa system for receiving and managing document processes at the Agency.
  • The measure aims to comply with the new Clinical Research Law (Law 14,874/2024), which regulates research with human beings and establishes the National System of Ethics in Research with Human Beings.
  • With the new guidelines established by the legislation, which include a 90-day deadline for the health analysis of these primary petitions, the simplification of the subject codes aims to increase the agility in the screening, document analysis and decision-making.
  • This measure responds to the growing volume of petitions and ensures compliance with the established deadlines.

Source: Anvisa

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

New Zealand
4 November
Updated Guidelines on the Regulation of Therapeutic Products in New Zealand

Edition 5.4 (Nov 2024) of the above guideline has now been published.

This was a minor update in which the name of the recognised authority of Hungary was updated from National Institute of Pharmacy and Nutrition (NIPN) to National Center for Public Health and Pharmacy (NCPHP).

Source: Medsafe

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
16 October
Nitrosamine impurities acceptable intakes update – October 2024

TGA has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information.

The changes include:

  • additional clarification for sponsors and manufacturers of the TGA’s expectations,
  • increases to the AI limit for some nitrosamine impurities
  • inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines
  • minor editorial amendments.

Sponsors and manufacturers are expected to be familiar with the current AIs for nitrosamine impurities in medicines. 

Source: TGA

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

Malaysia
28 November
Product classification form updated

Nn updated version (November 2024) of the Product Classification Form – NPRA/413/01-is now available for download at the link below.

Source: NPRA

15 November
Announcement to Product Registration Holders (PRHs): Pilot Project for Post-Approval Changes (Variation) Using Reliance

NPRA has been conducting a pilot project to explore the use of reliance for post-approval changes (variation).

  • This initiative is on-going and is expected to conclude by 1 June 2025.
  • This pilot will help the NPRA assess the effectiveness of utilising reliance approach for post-approval changes, aiming to reduce timelines and improve efficiency.

The requirements for this pilot and the steps for submission are listed at the link below.

Source: NPRA

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

Pakistan
15 November
DRAP Newsletter November 2024 published

DRAP has published the above quarterly newsletter featuring several key updates and initiatives.

  • DRAP has extended the scope of its Industry E-Reporting System for Adverse Drug Reactions to all registration holders, following a successful pilot project.
  • The newsletter details recent actions on:
    • the promotion of clinical trials regulatory oversight
    • the stakeholder queries management system and
    • interprovincial coordination for the implementation of the Institutional Development Plan as per WHO recommendations.
  • Additionally, the newsletter covers ongoing efforts to enhance public health and safety, including increased surveillance and regulatory actions to ensure the quality and safety of therapeutic goods.

Source: DRAP

30 October
Implementation of Industry E-Reporting System for the Reporting of Adverse Drug Reactions by Registration Holders

DRAP has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs).

  • This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods.
  • The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.
  • The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies.
  • Access to this system will be secure, with two accounts provided per registration holder.
  • Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders.
  • Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.

Source: DRAP

29 October
Directive of the Registration Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)

Following the Registration Board in 340th meeting held in early October, applicants are directed to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for Finished Pharmaceutical Products (FPP).

Source: DRAP

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

Japan
1 November
PMDA establishes US Office

PMDA has established an office in Washington, D.C. This is PMDAs second overseas office after the Asia office that was established in Thailand in July.

As more and more innovative drugs are being developed by overseas start-ups (especially in the U.S.), such drugs are needed to be developed rapidly also in Japan. To work on the issue, the PMDA decided to establish the office in Washington, D.C.

Source: PMDA

28 October
First PMDA overseas office established

On 29 August , to commemorate the establishment of the PMDA Asia Office which is the first PMDA overseas office, the “International Symposium for Asia Regulatory Coordination” was held in Bangkok, Thailand.

In this symposium, the purpose and activities of the Asia Office were introduced and the three sessions listed below were held with the aim of strengthening regulatory cooperation in Asia.

  • “Changes in the Regulatory Environment Surrounding the Asian Region and Responses”
  • “Challenges for Capacity Building of Asian Regulatory Authorities”
  • “Asia Clinical Trials and Collaboration with Asian Regulatory Authorities”

In each session, the perspectives on how PMDA will contribute through the Asia Office towards regulatory cooperation in Asian region and the expectation to the Asia Office were shared among regulators and organizations.

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

Brazil
22 November
Anvisa provides guidance to companies on procedural instructions for notification and registration of medical devices

Anvisa sent out Circular Letter 01/2024/SEI/GGTPS/DIRE3/ANVISA to companies holding medical device registration and notifications, with guidelines on the procedural instructions for medical device notification and registration petitions. 

  • The objective is to avoid rejections due to non-compliance with current regulations.
  • The document addresses the requirements for submitting documents that require sworn translation and legally valid signatures for petitions related to medical devices.
  • Additionally, it provides clarifications regarding the minimum level required for electronic signatures in interactions with public entities, in acts of legal entities.

Source: Anvisa

29 October
Anvisa publishes list of companies that can manufacture or import custom medical devices

Anvisa has published the list of companies authorized to manufacture or import custom medical devices.

The publication of the list is provided for in the Collegiate Board Resolution (RDC) 925/2024 , published on September 19, 2024, which deals with the requirements for the manufacture, marketing, import and exposure to use of personalized medical devices.

Personalised medical devices are any of three types of medical devices that are intended for a particular individual:

  • custom-made medical device
  • patient-specific medical device, or
  • adaptable medical device.

Adaptable medical devices and patient-specific medical devices need to be registered with Anvisa. Custom-made medical devices, on the other hand, have a different regulatory process. The process is outlined at the link below.

Source: Anvisa

European Commission
21 November
Gradual roll out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024)

This is a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

Source: European Commission

5 November
Update – Notified bodies survey on certifications and applications

You can view the update here.

Commissioned by: The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA)

Aim: To support monitoring and analyzing the availability of medical devices on the EU market in the context of the implementation of medical devices and in vitro diagnostic medical devices Regulations from the perspectives of key stakeholders

Duration: 2 December 2022 – 1 December 2025 (36 months)

Source: European Commission

30 October
Q&A Obligation to inform in case of interruption or discontinuation of supply

This document is a Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

Source: European Commission

UK
14 November
Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices

The MHRA is inviting members of the public to provide their views on proposals to update the regulatory framework for medical devices. 

This consultation applies to medical devices in Great Britain.

The views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public are welcomed on on four areas: 

  • International reliance 
  • UKCA marking 
  • In vitro diagnostic devices 
  • Assimilated EU law

You can view the consultation questions here and respond online here.

Consultation start date: 14 Nov 2024

Consultation end date: 4 January 2025

18 October
MHRA to launch consultation on device international reliance plan by end 2024

The MHRA plans to publish a public consultation on a proposal to enable medical devices to gain access to the UK market more quickly if they are authorized in a comparable regulator country (CRC) by the end of 2024.

  • Depending on the outcome of the consultation, the international reliance (IR) policy could be introduced as legislation in the British Parliament in 2025.
  • Rob Reid, deputy director for innovative devices at MHRA, updated attendees on a statement of policy intent published in May which proposed a high-level approach to allow devices in the UK market that have been authorized by CRCs, beginning with regulators in Australia, Canada, the EU, and the US.
  • From the comparable regulators i.e. TGA, Health Canada, FDA and the EU, the MHRA would take a different approach in terms of the route to market in the UK depending on the risk classification of the device.
  • The purpose of the public consultation is to test that thinking whether it needs to exclude certain 510(k) products from the International Reliance (IR) or whether there are alternative routes that could allow those products on the UK market but with additional requirements.
  • The idea is to make sure to make sure that the MHRA are not excluding products that could be included with different checks and balances.
  • Reid noted that part of the reason to initially exclude certain 510(k)s was due to concerns about their risks and also whether MHRA would have access to the data that is needed to ensure the products are safe and effective for the UK market.
  • The proposal still needs cross-government approval, but once that is done, Reid said MHRA intends to publish the consultation before the end of 2024.
  • Laying the Statutory Instrument that will introduce the legislation for IR is likely in 025. Exact dates will depend on parliamentary and government processes.

Source: RAPS

Spain
8 November
AEMPS launches a new application for the communication of  in-house manufacturing of medical products by hospitals

AEMPS) has launched a new online application for the electronic submission of the communication of the start of the manufacturing activity of medical devices in hospitals for exclusive use in the hospital itself.

  • Such manufacturing must have the purpose of satisfying the specific needs of the group of patients for whom the products are intended, which cannot be satisfied or cannot be satisfied with the appropriate level of performance, by another product with CE marking on the market.
  • This activity is commonly known as  in-house manufacturing of medical devices.
  • Regulation  (EU) 2017/745 of the European Parliament regulates (via Articcle 5.5) the requirements for the manufacture of medical devices in-house in healthcare centres.
  • Additionally, Royal Decree 192/2023 , of March 21, regulating medical devices, establishes in its article 9 the requirements and conditions for carrying out this activity in Spain.
  • It should be noted that, according to the Royal Decree, this activity can only be carried out by hospitals and the manufacture of products of classes IIb, III, or implantable products is not permitted.
  • On the other hand, the presentation of a communication prior to the start of the activity to the AEMPS is required.
  • Likewise, hospitals must communicate through this means any modification in the activity or the communicated products.
  • It should be noted that this manufacturing does not apply to custom-made medical devices, which require a prior operating license for their manufacture by the Autonomous Community.
  • Hospitals will be able to access the application using a username and password.
  • Each hospital must have a coordinator to request registration in the application. Instructions for accessing the application and submitting the communication can be found on the AEMPS website .

Source: AEMPS

European Parliament
23 October

MedTech Europe has welcomed the European Parliament’s vote on the joint motion for a resolution on the urgent need to revise Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)), which calls for measures to be adopted to address key challenges and bottlenecks in the implementation of the MDR1.

The European Parliament calls on the Commission:

  • to propose, by the end of Q1 2025, delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible
  • to make full use of legislative and non-legislative tools to resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers, particularly SMEs, without compromising patient safety

Sources: lexisnexis.co.uk1

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

European Medicines Agency
29 November
Data Quality Framework for EU medicines regulation: application to Real-World Data

This document describes the Real-World Data (RWD) specific recommendations as derived from the Data Quality Framework (DQF) for EU Medicines regulation endorsed by the Committee for Medicinal Products for Human Use (CHMP) (hereafter referred to as EMRN DQF).

  • The EMRN DQF sets out the principles, concepts, and definitions as intended to be applied widely across datasets used in medicine regulatory use cases.
  • It also provides examples and in-depth clarifications on the developed framework elements for characterising, assessing, and assuring DQ in the regulatory context.
  • It is therefore recommended to use the EMRN DQF as a companion document when reading this chapter.

Comments should be provided using this EUSurvey form.

Consultation start date: 29 November 2024

Consultation end date: 31 January 2025

European Platform for Regulatory Science Research 3 Concept paper – DRAFT

This concept paper presents a proposal for creating a European Platform for Regulatory Science Research.

  • The purpose of the concept paper is to outline the proposal and principles for the platform.
  • The public consultation of this document aims to generate interest and comments from the public, to refine the scope and development of the platform.
  • The concept paper will be the basis for the platform’s terms of reference.

You can provide comments using this template. The completed comments form should be sent to regulatory.science@ema.europa.eu.

Consultation start date: 14 November 2024

Consultation end date: 18 December 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

Source: European Commission

Pakistan
5 November
Draft Guidance Document For Clinical Trials Of Biological Products manufactured locally

The draft guidance of the first edition of the guideline with the above title has been published.

This guideline is applicable to the firms who intends to apply for registration / Marketing
Authorization of Biological drug products for human use manufactured locally

DRAP seek comments from stakeholders. No deadline for comments has been given.

Source: DRAP

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

UK
14 November
MHRA seeks views on pre-market regulations for medical devices to improve patient access and strengthen patient safety

The MHRA has launched a consultation on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain.

The consultation will focus on four policy areas that have evolved significantly since the MHRA’s initial consultation to strengthen medical devices legislation was launched in 2021.

The four policy areas that the MHRA is consulting on are:

  1. UKCA marking
  2. International reliance
  3. In vitro diagnostic (IVD) devices
  4. Assimilated EU law

The findings from this latest consultation will inform new legislation, the Pre-market Statutory Instrument, which is expected to be laid in Parliament next year.

You can take part in the consultation here. 

Further information is available in this post by Bristows.

Consultation start date: 14 November 2024

Consultation end date: 5 January 2025

Source: MHRA

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

European Medicines Agency
21 November
EMA to consult on key biosimilarity requlatory requirement in 2025

The EMA currently requires comprehensive comparative efficacy studies to be performed by biosimilar manufacturers in order to demonstrate ‘biosimilarity’ between their product and the originator biologic their product in order to to obtain a marketing authorisation This requires conducting expensive and time-consuming clinical trials with patients.1

Whilst other medicines regulators e.g. the US FDA also require comparative efficacy trials to be carried out, the UK MHRA has a different approach. According to its revised guidance of November 2022, a comparative efficacy trial may not be necessary in most cases if sound scientific rationale supports this approach. That allows biosimilar manufacturers to rely more heavily on comparative analytical and functional data as well as what is known from clinical experience and quality attributes of the originator biologic product, to meet their regulatory requirements.1

The EMA’s approach is currently under internal review. In a concept paper published in Q4 2024, it consulted on a tailored clinical approach in biosimilar development ( consultation closed in Apr 2024) and confirmed some changes to regulatory requirements around clinical efficacy trials were under consideration.1

When Out-Law (from Pinsent Masons) recently asked the EMA to confirm when it is expecting to set out its next steps. the EMA confirmed that it is in the process of drafting a “reflection paper” as a follow up to its concept paper and plans to consult on it sometime in 2025.1

According to Amsterdam-based Carly van der Beek of Pinsent Masons: “Since the early 2000s, many biological medicinal products have entered the market. Between then and now, a wealth of information on biologicals such as mAbs has become available. The EMA, adjusting to this reality, recognises that similarities at the analytical and functional level have increased the comparability for biosimilars while maintaining the highest standards of safety and efficacy.”1

“This can be a game-changer, increasing the options for patients and prescribers navigating the market. Moreover, as the drug-budget can be used more efficiently, this may allow for the use of newer, high-cost treatments,” she added.1

Source: EMA to consult on biosimilars regulatory requirements in 2025, Arjan Reijns et al , 21 November 2024, Pinsent Masons

UK
18 October
Proposed update to the statutory scheme to control the cost of branded health service medicines -Government response

In this consultation, the government proposed updates to the statutory scheme to maintain broad commercial equivalence with voluntary scheme for branded medicines pricing, access and growth (VPAG). The consultation proposes to introduce a differentiated approach to setting payment percentages for newer medicines and older medicines, and includes proposals on:

  • defining older and newer medicines
  • setting the headline payment percentage for newer medicines
  • setting the basic payment percentage and top-up payment percentage for older medicines
  • calculating the price decline of older medicines.

You can read the government response to the consultation outcome here.

Source: gov.uk

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
AI in supporting postmarket drug safety research

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

Switzerland
4 December
Public consultation on ICH Guideline E6(R3) Annex 2 “Good Clinical Practice (GCP)” launched in Switzerland

In the two decades since ICH E6 was first drafted, clinical trials have become more complex with respect to trial design, use of technology, quantity of data collected and involvement of central testing facilities or other service providers.

  • The scope of E6(R3) is to expand, modify, and reorganise all appropriate sections to provide scientific and ethical guidance that enables a diversity of approaches that are relevant and adaptable to the variety of clinical trial designs and innovative technologies.
  • When complete, E6(R3) will be composed of
    • an overarching principles and objectives document
    • Annex 1 (interventional clinical trials) and
    • Annex 2 (additional considerations for non-traditional interventional clinical trials)
  • The proposed development of Annex 2 will include additional considerations on how GCP principles may be applied across a variety of trial designs and data sources, where applicable.
  • These additional considerations are based on the foundation established in Annex 1.
  • Annex 2 should be read and implemented with E6(R3) principles and Annex 1.

Links to the guideline and feedback form can be found on this page:

Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch. 

Consultation start date: 4 December 2024

Consultation end date: 28 February 2025

Public consultation for ICH Guideline M15 “General Principles for Model-Informed Drug Development” (MIDD) launched in Switzerland

The new overarching ICH M15 MIDD General Principles Guideline will broadly cover the general principles and good practices for the use of MIDD.

  • The guideline will establish a common understanding across multidisciplinary scientists, both within and between regulatory authorities and industry.
  • Additionally, the guideline will harmonise expectations regarding documentation standards, model development, data used in analysis, model assessment and its applications.

Links to the guideline and feedback form can be found on this page:

Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch. 

Consultation start date: 4 December 2024

Consultation end date: 28 February 2025

UK
15 November
MHRA Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2

The update of ICH E6 is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines to support regulatory and healthcare decision making.

ICH E6(R3) has been restructured and is composed of:

  • an overarching principles section
  • Annex 1 (interventional clinical trials)
  • Annex 2 (additional considerations for non-traditional interventional clinical trials)
  • Glossary and
  • Appendices

The Annex 2 concept paper was endorsed by the ICH Management Committee on 28 April 2023 and was published on the ICH website.  

Annex 2 has now reached Step 2b and is available for public consultation.

Consultation state date: 15 November 2024

Consultation end date: 14 Feb 2025

You can learn more about the ICH in this blog post.

Source: MHRA