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
8 January 2025
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) updated

The MHRA has updated the above guidance as follows:

  • Updates made to indicate requirements for Category 1 and Category 2 products following the implementation of the Windsor Framework.
  • PSMF accessibility – Sentence added to state that PSMF must be up to date at the point it is sent to the licensing authority.

Source: MHRA

Guidance on MAH and QPPV location updated

The MHRA has updated the above guidance to indicate requirements for Category 1 and Category 2 products following the implementation of the Windsor Framework.

  • The QPPV for UK nationally authorised products (including both Category 1 and Category 2 products as well as PLNI licenses and PLGBs) ) can reside and operate anywhere in the UK or the EU/EEA.
  • Where the QPPV does not reside and operate in the UK, there will be a need for a national contact person for pharmacovigilance who resides and operates in the UK. 

Source: MHRA

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

Switzerland
1 January 2025
Optimization of the Labelling Phase for Human Medicinal Products

1. Intensified exchange Swissmedic – Company in the labelling phase

In order to avoid text review letters whenever possible, this direct exchange by means of an informal letter via the eGov portal should be used more frequently. Therefore, from January 1, 2025, the following will apply to all applications with drug information texts:

  • The open points will now be addressed directly in the corresponding manuscripts and the revised drug information texts will be exchanged via informal exchange on the eGov portal. As before, no new eCTD sequence is required for this.
  • The company deadline can now be extended once by 5 calendar days upon request.

Official text review rounds with longer deadlines should only be initiated if additional documentation is necessary or if the applicant needs more time (> 10 calendar days) to clarify the open points (e.g. due to more extensive clarifications).

2. Shortening of Swissmedic deadlines in the labelling phase (for new applications with new active substances)

In cases where an official text review letter cannot be avoided, Swissmedic is shortening its deadline for the application phase ‘Assessment of response to text review letter’ for new applications with a new active substance from 90 to 45 calendar days from 1 January 2025.

Source: Swissmedic

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

Turkey
11 December
For the attention of anyone conducting clinical research

The documents “Benefit-Risk Assessment Plan/Report” and “Pediatric Research Plan” have been updated and  are available  at https://www.titck.gov.tr/faaliyetalanlari/ilac/klinik-arastirmalar under the title “Application-Forms/First Application” .

These documents must be used as of 11 December 2024.

Source: TITCK

9 December
Guide on packaging and excipients

Revision 14 (Dec 2024) of this guide has been published. It includes all of the following guidance documents.

  • 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 and
  • Guide on Excipients in Packaging Information and Instructions for Use of Medicinal Products for Human Use” have been updated and published.

You can view it here.

Source: TITCK

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

Ireland
2 January 2025
Guide to Fees for Human Products

This document has been updated. Here, you can view the track changed and clean versions.

Source: HPRA

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

Finland
2 December
Common pharmaceutical packs pilot to commence in the Nordic countries aiming to improve product availability

For decades now, the Nordic pharmaceutical authorities have worked together to increase the availability of medicines in the Nordic countries with common Nordic packs for medicines.

  • There has been a shortage of several vital medicinal products in the Nordic market for a while now.
  • Each Nordic country is a relatively small market, which makes them individually less attractive compared to larger market countries
  • Currently, pack labelling is required to be in the national languages.
  • There have already been some common Nordic packs with several Nordic languages.
  • However, ensuring sufficient access to medicines is challenging when separate packaging in different languages is required.
  • A pilot starting at the beginning of 2025 will be testing the usability of having some Nordic hospital product packages in English in all the Nordic countries: Denmark, Finland, Iceland, Norway and Sweden. 
  • The aim of this new availability project is to improve the availability of critical hospital products in all Nordic countries by simplifying production and distribution.
  • The pilot project will aim to find out whether certain small-scale but critical medicinal products can be exempted from Nordic language requirements and how only using English on packs would work in practice.
  • The pilot only includes hospital medicines that are administered by health care professionals.

Source: Fimea

Canada
10 January 2025
Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format

Health Canada has updated the validation rules for regulatory transactions submitted in the eCTD format, to reflect recent and upcoming changes in its processes. These rules are built in accordance with the information provided in the following documents:

  • Guidance Document – Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format;
  • Creation of the Canadian Module 1 Backbone (eCTD) format – Guidance Document
  • International Council for Harmonisation (ICH) Electronic Common Technical Document Specification (Version 3.2.2)
  • Guidance Document: The Regulatory Enrolment Process (REP)

The purpose of the validation rules is to help ensure Sponsors provide a valid electronic transaction to Health Canada, and reduce errors and follow-up with Sponsors.

  • Sponsors are encouraged to use a commercially available tool to validate their regulatory transactions in eCTD format, prior to filing them to Health Canada.
  • Health Canada validates each regulatory transaction as it is received.
  • If the validation fails due to one or more errors detected, an eCTD Validation Report describing each error will be emailed to the sponsor as a.pdf file attachment.

Version of the eCTD validation rules: 5.3 will be effective from 31 May 2025.

Full details of the of the update are available at the link below.

Source: Health Canada

Validation rules for regulatory transactions in non-eCTD format

Health Canada has also updated the validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information provided in the following documents:

Version of the non-eCTD validation rules: 5.3 will be effective from 31 May 2025.

Full details of the of the update are available at the link below.

Source: Health Canada

18 December
Notice to stakeholders – Publication of updates to the Quality (Chemistry and Manufacturing) guidance: New drug submissions and abbreviated new drug submissions & the guidance document: Labelling of pharmaceutical drugs for human use documents

There are new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These amendments were introduced through the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) regulatory package and are part of Health Canada’s modernization work. The amendments will :

  • reduce regulatory issues and roadblocks to innovation
  • make Canada’s science-based regulatory system more agile
  • bring the Health Canada regulatory system in line with international approaches

As part of the Agile regulatory package, the following amendments were made:

  • Where a manufacturer uses a manufacturer’s standard for a new drug (i.e. a drug regulated under Part C, Division 8 of the FDR), the Regulations exempt them from having to meet the most stringent limits for purity and potency of all the Schedule B pharmacopoeias in which the active ingredient or drug appears. This allows those manufacturers who use a manufacturer’s standard to have different limits for purity and potency than the most stringent listed under Schedule B, that are acceptable to the Minister. This exemption does not apply to new drugs regulated under Schedule C (radiopharmaceutical drugs). Manufacturers who use a manufacturer’s standard for drugs that are not new drugs will continue to be required to meet the most stringent limits for purity and potency of all the Schedule B pharmacopoeias.
  • For all drugs, other than those regulated under Part C, Divisions 3 and 4 (i.e. radiopharmaceuticals and biologics) of the FDR, the Regulations remove the requirement for the standard used for the drug to be indicated on the package label.

As a result of these amendments, updates have been made to:

In addition, changes have been made to the former guidance to update the information in relation to nitrosamines.

Source: Health Canada

New agile regulatory provisions and updated guidance document for submitting risk management plans: Notice

The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing), also known as the Agile Regulations, were published on December 18, 2024, in Canada Gazette, Part II.

  • The new provisions in the Food and Drug Regulations that relate to risk management plans will come into force on April 1, 2027.
  • The provisions will reinforce Health Canada’s long-standing practices on submitting risk management plans (RMPs) to support a lifecycle approach to the regulation of drugs.
  • Health Canada has put in place transitional provisions to help transition RMPs that will have been submitted under our existing policy before the Agile Regulations come into force.
  • Exisitng RMPs
    • An RMP provided before coming into force will be considered an existing RMP if Health Canada has already indicated that it was acceptable.
    • Existing RMPs will be subject to the RMP updating provisions once they come into force.
    • A post-market RMP or an RMP update provided before coming into force, and is still being reviewed at the time of coming into force, would be considered an existing RMP once Health Canada has indicated to the manufacturer that the RMP is acceptable.
    • An RMP provided before coming into force with a Division 1 pre-market application and for which a DIN has not yet been issued at the time of coming into force, would be considered an existing RMP once Health Canada has issued a DIN.
  • Review of RMPs at coming into force
  • In accordance with the Agile Regulations, RMPs must meet the requirements set out in section C.01.701 of the Food and Drug Regulations. This will apply to the review of:
    • any RMP provided before coming into force with a Division 8 pre-market submission or supplement to a submission, for which an issuance decision has not yet been made at the time of coming into force
    • any RMP provided before coming into force with a Division 1 pre-market submission, for which a DIN has not yet been issued at the time of coming into force
  • Any post-market RMP or RMP update provided before coming into force is expected to meet our existing RMP policies outlined in guidance.
  • All RMPs provided on or after April 1, 2027, must meet the requirements set out in section C.01.701 of the Food and Drug Regulations.

Source: Health Canada

Guidance document: Labelling of pharmaceutical drugs for human use

The latest revision of this document is dated 18 December 2024. The guidance also became effective on the same date.

Source: Health Canada

Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing): SOR/2024-238
Amendments have been made to the Food and Drug Regulations and Medical Devices Regulations that advance Health Canada’s modernization agenda by making Canada’s science-based regulatory system more agile and internationally aligned.
You can view all the amendments ant the link below.

Source: Health 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
31 December
CDER Nitrosamine Impurity Acceptable Intake Limits

Updates have been made to the following Tables:

  • Table 1: FDA Recommended AI Limits for Certain Hypothetical NDSRIs and Other Identified Nitrosamine Impurities
  • Table 3: Recommended Interim AI Limits* for Certain Nitrosamine Impurities** for Approved or Currently Marketed Products

The revision table at the end of the page shows all the revisions. Whilst Table 2 shows as having been updated on 31 Dec 2024, the table at the end of the page does not show any updates in Table 2.

Source: FDA

12 December
CDER establishes new Center for Real-World Evidence Innovation

The U.S. FDAs CDER announced the new CDER Center for Real-World Evidence Innovation (CCRI) which aims to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making across CDER.

  • RWD relates to a patient’s health status and/or the delivery of health care routinely collected from a variety of sources e.g.:
    • electronic health records,
    • medical claims,
    • product and disease registries, and cutting-edge technologies  
  • By using data from routine clinical practice, evidence can be generated (referred to as RWE) that provides valuable insights into the safety and effectiveness of medical products.

The goal of CCRI will be to advance, coordinate, and promote consistency across RWD/RWE-related initiatives in CDER, including related uses of emerging technologies in both internal and external FDA activities. CCRI is envisioned as a collaborative core for innovation and a focal point to ensure CDER promotes consistency and transparency on topics related to RWD and RWE.

You can view an FAQ on CCRI here.

Source: FDA

Brazil
23 December
Anvisa selects priority foreign authorities to strengthen regulatory confidence

In a meeting of the Strategic Management, Risks and Institutional Innovation Committee (CGE), Anvisa approved a list of priority Equivalent Foreign Regulatory Authorities (AREEs).

  • The objective is to develop and consolidate the practice of regulatory trust, known as reliance , in relation to the decisions taken by the Agency.
  • The initiative is aligned with the fifth strategic objective of Anvisa’s Strategic Plan 2024-2029, which establishes the goal that 70% of priority regulatory authorities adopt regulatory trust practices based on the Agency’s decisions.
  • This strategy is essential for Anvisa’s recognition as an international health authority of reference.
  • The selection includes AREEs that play a relevant role in registrations and inspections for compliance with good manufacturing practices (GMP) for medicines and medical devices.
  • Check out the list of authorities and their respective functions at the link below.

Source: Anvisa

19 December
New dashboard provides data on clinical investigations involving medical devices

Anvisa has launched a new Business Intelligence (BI) dashboard with clinical investigations involving medical devices authorized in Brazil.

  • The business intelligence platform provides transparency into the status of the Agency’s approvals.  
  • The new feature allows you to consult various data, such as the type of investigation, the category of medical devices, sponsors, principal investigators and clinical research centers. 
  • Click here to access the “Clinical investigations with medical devices authorized in Brazil” panel.

Source: Anvisa

12 December

Anvisa has published the document  Reflections & Perspectives: Regulation, Clinical Research and Innovation which provides strategies and guidelines to strengthen the clinical research ecosystem in Brazil, in addition to boosting innovation in the health sector.

The initiative is part of the Agency’s commitment to promoting the health of the Brazilian population by encouraging the development and innovation of new medicines.

Among the main initiatives addressed in the document are the following:

  • review and modernization of regulatory frameworks for clinical research and drug registration;
  • simplification and flexibility of the regulatory framework for biosimilars
  • launching of notices for monitoring and technical and scientific guidance
  • development of strategic partnerships, such as the creation of a center dedicated to regulatory science
  • strengthening national capacities for conducting clinical research.

By aligning its regulatory efforts with other actors in the innovation ecosystem, Anvisa contributes to making the Brazilian healthcare sector more resilient and innovative.

Source: Anvisa

Anvisa initiatives to promote access to new medicines

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

Australia
20 December
Recall reforms update and new procedure

The TGA is providing sponsors with advance notice of the final package of the recall reforms which will be implemented in early March 2025.

  • This includes providing a preview of Australia’s new recall procedure which will be known as the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
  • Sponsors will continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until early March 2025, at which time the URPTG will be replaced by the PRAC.
  • TGA will advise the precise implementation date closer to this time.

The PRAC will:

  • enhance the transparency, communication and timeliness of recalls, alerts and corrections
  • introduce new market action terminology, reducing the categories from 8 to 4
  • halve the number of steps in the process from 10 to 5 but will not require any major changes to how sponsors approach the process
  • feature fewer pages with less repetition, clearer information and instructions.

To complement the new PRAC, TGA will be releasing enhancements to its IT systems, including the TBS Portal, and the publicly accessible System for Australian Recall Actions (SARA) database, which will be renamed to the Database for Recalls, Product Alerts and Product Corrections’ (DRAC), also from early March 2025.

Source: TGA

9 December
Automatic extension of Mutual Recognition Agreement (MRA) GMP clearances

GMP Clearances issued via the MRA pathway that are expiring on 31 December 2024 will be automatically extended until 31 December 2025. 

  • This is due to ongoing delays with MRA partners returning to pre-pandemic inspection frequencies.
  • Sponsors do not need to submit an extension application and the TGA will begin processing these extensions from 9 December 2024. 
  • Any applications for extensions submitted by Sponsors will be removed from the system as they will not be required.

Source: TGA

Changes to TGO 91 for injectable electrolyte medicines

TGA has made changes to Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) to make medicine labels clearer for health professionals.

These changes will help to make quantities of active ingredients clear on labels and in units important to health professionals.

For injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less):

  • The label must express potassium chloride quantity in millimoles on the label. Labels must also include the quantity of potassium chloride in weight except in certain circumstances.
  • The label must continue to express the quantity of other active ingredients in weight. It must also include the quantity in millimoles of each ingredient.
Updates to guidance about medicine labels

TGA has updated Labelling medicines to comply with TGO 91 and TGO 92 to include more information for medicine sponsors about:

  • complying with the new requirements for injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less)
  • providing instructions for preparation where injectable medicines are administered by healthcare professionals.

TGA has also updated the instructions for preparation package insert template to give more clarity to medicine sponsors. Read more about including a package insert and the template: ensuring compliance after removing the product information insert.

For sponsors of injectable electrolyte medicines

TGA is applying a transition period until 30 November 2026.

From 1 December 2026, applicable products imported or released for supply must comply with the new requirements.

You must make a variation when updating your labels. Please use the following Self-assessable request (SAR) code if you meet the conditions:

  • LOEI – Label – changes to the method of expressing the content of active ingredients or excipients, in accordance with the current labelling TGO.

If LOEI is not applicable, consider using:

  • LOTG – Label – changes to comply with current TGOs for labels that have previously been evaluated and approved by the TGA.

Source: TGA

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

India
30 December
Submission of applications for clinical trial site addition and change of principal investigator.

In order to streamline regulatory submissions, the above applications can now be submitted via the online SUGAM portal. Further inforation is available in this notice.

Source: CDSCO

Malaysia
20 December
Application Forms for Clinical Trials

All of the following forms have been updated. The current edition of each of the forms is dated Dec 2024. You can view/download the updated forms here.

  • N2-FR-07/3 Clinical Trial Import License (CTIL) Application Form
  • N2-FR-08/3  Application Form for Permission to Manufacture Unregistered Products for Clinical Trial Purposes (CTX)
  • N2-FR-09/3 CTIL CTX Variation Application Form
  • N2-FR-13/2 Clinical Trial Import License Processing Fee Submission Form
  • Standardised file organisation folder for CTIL/CTX application (Ver. May 2024)
  • N3-FR-27/2 CTILCTX Protocol Deviation Template
  • N3-FR-26/4 Inspection Application For NPRA Phase One Unit Inspection and Accreditation Program

Source: NPRA

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

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

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

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

Northern Ireland
7 January 2025
Guidance updated: Regulation of devices in Northern Ireland

There has been an update to the ‘Clinical investigations and performance studies in Northern Ireland’ section of this guidance.

Source: MHRA

Switzerland
1 January 2025
Adaptation of the regulations on in vitro diagnostics (IVD) and medical devices

The amended regulation on in-vitro diagnostic medical devices (IvDV) will come into force on 1 January 2025.

With the entry into force of the amended Ordinance on In Vitro Diagnostics (IVDV) today, Switzerland is implementing the extended transition periods in accordance with the EU regulation. This restores regulatory equivalence with the EU.

On June 13, 2024, the “Regulation (EU) 2024/1860 adapting the EU IVDR as regards the transitional provisions for certain in vitro diagnostic medical devices and adapting the EU MDR and EU IVDR as regards the gradual introduction of EUDAMED” was published.

  • In the EU, this extended, among other things, the validity periods for certificates under the old law – depending on the risk class – until 2027, 2028 or 2029 in order to address bottlenecks at the notified bodies.
  • This and the planned permanent simplification of the labeling requirement for products supplied to professionals (Article 87 IvDV) are intended to ensure the supply of IVDs in Switzerland.
  • Healthcare institutions will also be given more time to prove that their “in-house products” / “laboratory developed tests” (LDT) cannot be replaced by comparable CE-marked market products. This proof requirement will not come into force until December 31, 2030, instead of May 26, 2028 as originally required.
  • The aforementioned adjustments were adopted by the Federal Council decision of 20 November 2024 and came into force on 1 January 2025.

Note that the new reporting obligation under Article 10a EU-MDR and EU-IVDR, according to which manufacturers must report the interruption or termination of the supply of certain medical devices, is not part of this Swiss regulation revision.

In addition, the product registration requirement already provided for in the Medical Devices Regulation (MepV) and the IvDV will come into force on 1 July 2026, six months after the expected registration requirement in EUDAMED.

Source: Swissmedic

UK
17 December
Clinical investigations guidance updated

The guidance in section the Northern Ireland has been updated to Include attachments for ‘flow chart‘ and ‘accompanying guidance‘ and revised wording in the section Serious adverse event (SAE) reporting.

Source: MHRA

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

Singapore
4 December
Pilot run: Change Management Program (CMP) for SaMD, including Machine learning-enabled SaMD

As part of HSA’s ongoing initiative to improve regulatory efficiency, the Medical Devices Cluster (MDC) is rolling out a Pilot run of Change Management Program (CMP) for SaMD, including Machine learning-enabled SaMD.

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.

With effect from 4th December 2024, please follow the 2-steps detailed on this page if you would like to enrol into the Program.

Source: HSA

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

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

Canada
28 December
Consultation on proposed amendments to regulations to address health product shortages in Canada

Health Canada is proposing to amend the Food and Drug Regulations and Medical Devices Regulations to help prevent and mitigate the risk of harm to human health due to drug and medical device shortages and discontinuations. The proposed amendments:

  • Your ideas and input are sought around the proposed amendments to the Food and Drug Regulations and Medical Devices Regulations concerning shortages and discontinuations for drugs and medical devices, and the associated draft guides. The regulatory amendments would give Health Canada more tools to help prevent adverse health outcomes due to a drug or medical device shortage.

The input gathered through this consultation process will help Health Canada:

  • design systems and procedures that promote readiness and a rapid response to shortages
  • detect when there’s a risk of a shortage and intervene to help avoid the shortage before it happens
  • detect early shortage signals to minimize their impacts when they occur and restore access to needed products quickly

Among those that Health Canada wants to hear from are the following:

  • drug and medical device industry stakeholders, such as:
    • manufacturers
    • distributors
    • wholesalers and importers
    • industry associations

You can participate in the consultation via this page

Consultation start date: 28 December 2024

Consultation end date: 8 March 2025

Consultation end date:

Ireland
20 December
Public consultation on the development of the HPRA’s 2026–2028 Strategy

The HPRA is inviting you to participate in the development of HPRAs 2026–2028 Strategy.

  • As a regulator, the HPRA works for the benefit of people and animals and so your input, and insights are critical in shaping the HPRA’s future direction and role in the regulatory landscape.
  • Aligned with HPRA’s values of inclusivity and engagement, it is committed to ensuring the new strategy reflects your perspectives.
  • Your feedback will help assess the current strategy, highlight opportunities for improvement, and identify emerging priorities in the regulatory landscape.
  • You can respond to the survey here by 17 January 2025. It should take approximately 10–15 minutes to complete, and all responses will be treated as anonymous.
  • Please email the HPRA at info@hpra.ie if you have any queries.

Consultation start date: 20 December 2024

Consultation end date: 17 January 2024

Source: HPRA

European Commission
18 December
Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)

This is a targeted amendment to the Commission Implementing Regulation (EU) No 520/2012 harmonising the performance of pharmacovigilance activities by marketing authorisation holders, national competent authorities and the European Medicines Agency. Those activities cover the whole life-cycle managements of medicines with regard to safety.

You can view the draft implementing act here and respond to the consultation here.

Further information is available in this article from Grant Castle et al of COvington.

Consultation start date: 18 December 2024

Consultation end date: 15 January 2025

Source: European Commission

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

1 January 2025
Feedback invited on standard IVD evaluation protocols drafted by ICMR and CDSCO

Licensure of In-Vitro Diagnostics (IVDs) under Medical Devices Rules 2017 requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance.

  • To facilitate this process, the Indian Council of Medical Research (ICMR) and CDSCO have come together to draft standard evaluation protocols for use by IVD manufacturers testing labs in India.
  • Fourteen IVD evaluation protocols have been developed by ICMR and CDSCO
  • The protocols are now being placed in the public domain for comments from relevant stakeholders.

Consultation start date: 1 January 2025

Consultation end date: 15 February 2025

Source: CDSCO

European Commission
12 December

The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as part of the targeted evaluation of these rules.

  • The consultation provides stakeholders with the opportunity to express their views on how the current rules are performing and to highlight possible shortcomings.
  • The evaluation will :
    • look among others at how effective the rules are and at the costs and administrative burden of the rules, especially for SMEs, and at the benefits for patients and users.
    • also consider the impact that the rules have on the availability of devices, including ‘orphan devices’ and on the development of innovative devices.

You can view the consultation and call for evidence here and respond here.

Consultation start date: 12 December 2024

Consultation end date: 21 March 2025

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

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

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
10 January 2025
Consultation on the ICH M15 Guideline for Model Informed Drug Development (MIDD)

The ICH M15 will provide general recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development (MIDD).

  • It establishes a harmonized assessment framework (including associated terminology) for MIDD evidence.
  • This was set out in the MIDD Discussion Group Roadmap and the M15 Concept Paper.
  • A Business Plan was developed. ICH M15 is composed of a framework for assessment of MIDD evidence, model evaluation, MIDD reporting and submission, Glossary and Appendices.
  • See the draft M15 guideline.
  • The M15 Concept Paper was endorsed by the ICH Management Committee on 10 November 2022 and was published on the ICH website.  
  • ICH M15 guideline has now reached Step 2b and is available for public consultation.

You can respond to the consultation here.

Consultation start date : 10 January 2025

Consultation end date: 31 March 2025

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

Canada
20 December
M12: Drug Interaction Studies

The M12 Guideline:

  • was implemented by Canada on 20 December
  • Is limited to pharmacokinetic interactions, with a focus on metabolic enzyme- and transporter-mediated interactions
  • Provides recommendations on how to investigate interactions mediated by inhibition or induction of enzymes or transporters, both in vitro and in vivo (the terms ‘clinical’ and ‘in vivo’ are used interchangeably in this document), and on how to translate the results to appropriate treatment recommendations and also includes recommendations on how to address metabolite-mediated interactions;
  • Provides recommendation for consistent approach to reduce uncertainty for the pharmaceutical industry to meet the requirements of multiple regulatory agencies and lead to more efficient utilization of resources.

Source: Health Canada

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