Last updated: 5 March 2025
To view updates, click on the ‘+’ sign below.
Multi-stakeholder workshop on Pharmacogenomics
In September 2024 the European Medicines Agencies Network (EMA and HMA) and the European Commission co-hosted a multi-stakeholder workshop on pharmacogenomics.
The workshop report is now available. It makes important recommendations on use of pharmacogenomics information in medicines development and regulation, and clinical practice to improve patient treatment outcomes.
Source: EMA
Procedural advice on CHMP/CAT/PRAC rapporteur/corapporteur appointment principles, objective criteria and methodology in accordance with Article 62(1) of Regulation (EC) No 726/2004
This document (revision 4 Feb 2025) has been revised in order to provide more clarity with regard to (co-)rapporteurship appointments taking into account case law and a European Ombudsman recommendation.
- The key elements of this revision are the requirement to consider the prior role of the (co-)rapporteur as coordinator for scientific advice for initial applications and changes in Rapporteurship, as well as the requirement to take into account if the National Competent Authority of the nominated Committee member adopted a decision or was involved in court proceedings related to the same subject matter identified in referral procedures.
- This document is also revised to reflect the change in process to no longer appoint a CHMP Pharmacovigilance Rapporteur for generics/hybrids.
Source: EMA
Report and minutes from the CMDh meeting held on 28-29 January 2025
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
The report and minutes from the above meeting include (but are not restricted to) the following items:
1. Template for Request for RMS in DCP
The CMDh agreed an update of the template for request for RMS in DCP.
- The document has been updated to include a field for the bioequivalence study number (as applicable) and a footnote to add the definition of the European Reference Medicinal Product.
- The declaration that no other Member State has agreed to become RMS for the procedure has been changed to a tick box and extended to pending requests.
- The updated document has now been published be published on the CMDh website under “Templates > Application for MA”. Here, you can view the track changed (June 2023) and clean (Jan 2025) versions of the document.
2. Procedural Advice on Repeat-Use
The CMDh agreed an update of the Procedural Advice on Repeat-Use.
- The main change is to align the guidance with the updated Best Practice Guide on Renewals.
- Other minor changes, in line with the experience gained, have been included.
- The updated document has now been been published on the CMDh website under “Procedural Guidance > Application for MA > MRP/RUP”. Here, you can view the track changed (Sep 2020) and clean (Jan 2025) versions of the document.
3. Questions and Answers on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
The EMA presented to the CMDh the updated CMDh/EMA Q&A on implementation of medical devices and in vitro diagnostic medical devices regulations.
- It clarifies that for an MAA, LE or variation of an integral drug-device combination product falling under the Art 117 provision, in case of a class I (excluding Is and Im) medical device, the MAH may submit a MAH’s statement of compliance with the relevant General Safety and Performance Requirements (GSPRs) of the MDR Annex I as an alternative to a Declaration of Conformity (DoC) when not available.
- The CMDh endorsed the Q&A document.
- The updated Q&A has now been published on the EMA website.
- Here, you can view the track changed (May 2024) and clean (Jan 2025) versions of the document.
Source: EMA
4. CMDh Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU reference date is not yet legally binding/followed
The CMDh agreed an update of the Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU reference date is not yet legally binding/followed as prepared by the Working Party on Pharmacovigilance Procedures Work Sharing.
- The update concerns a general revision of the guidance document and includes, among others, guidance and criteria for exceptional requests of an additional (ad hoc) PSUR upon request of an NCA (in accordance with Article 107c(2) of Directive 2001/83/EC as amended and as described in the GVP module VII section VII.C.3.3.4), i.e. outside of the scheduling or the DLPs set out in the EURD list.
- The updated document has now been been published on the CMDh website under “Pharmacovigilance > PSUR > Informal PSUR Worksharing”. Here, you can view the track changed (May 2023) and clean (Jan 2025) versions of the document.
5. CMDh Best Practice Guides for the Submission and Processing of Variations in MRP (Chapter 3 and 6)
The CMDh agreed an update of Chapter 3 (Type IA Minor Variations (Notifications)) and Chapter 6 ((Super-)Grouped Applications) of the Best Practice Guides for the Submission and Processing of Variations in MRP.
- The main change to the BPGs is to include information that a justification for the exceptional submission of type IA variations outside of annual updates (listed in Chapter 6 of the BPG on variations) should be clearly indicated in the background/scope section of the eAF.
- An optional wording to be used has been included in the guidance documents.
- The updated documents have now been published on the CMDh website under “Procedural Guidance > Variation”.
- Here, you can view the track changed (Oct 2024) and clean (Jan 2025) versions of BPG Chapter 3.
- Here, you can view the track changed (oct 2024) and clean (Jan 2025) versions of BPG Chapter 6.
6. CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity
The CMDh agreed an update of the SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity.
- As discussed previously and as is current practice, it has been reflected in the document that decisions on an additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh are published in a separate document (besides the CMDh minutes) and how the start date of the non-cumulative period of one year of data exclusivity for a new therapeutic indication granted under Article 10(5) should be calculated.
- The updated document has now been published on the CMDh website under “Procedural Guidance > Application for MA”. Here, you can view the track changed (June 2023) and clean (Jan 2025) versions of the document.
7. Experience with recent variation worksharing requests
Ireland raised some questions on the extent and scope of variation worksharing procedures based on their recent experience with these requests, following its mandatory use since January2025 under the amended Variation Regulation.
- The CMDh discussed variation worksharing (WS) requests covering large numbers of products where the reference authority (RA) does not have all the products authorised.
- It was noted that, the fact that a MS does not have all products covered by the WS authorised in their MS, should not be a reason for refusing to act as RA.
- Normally, if the outcome is the same for all products, the changes should be assessed in one WS procedure.
- In those cases, where the relevant authority identifies that a product-specific assessment is needed (for example, per pharmaceutical form), the MAH should be requested to submit separated WS variations.
- Additionally, this may result in a situation where a different MS has to be chosen as RA, namely if the initial MS acting as a RA has not granted a marketing authorisation for
- any of the medicinal products affected by the new WS procedure.
- In such cases, the assessment report could be shared but this is not always possible in case of type IB variations (as not all MSs prepare ARs or only very reduced ARs for type IB variations).
- It was agreed, as previously discussed, that requests covering a large number of products
- could be split into more than one procedure for technical reasons, but should preferably be sent to the same RA for assessment.
8. Art. 46 worksharing vs. Type II variation
The CMDh discussed the possibility to change the process for Art. 46 worksharing of paediatric studies when updates to the product information are proposed by the MAH, in line with the centralised procedure (i.e. if amendments to be introduced to the PI are identified by the MAH, a variation should be submitted directly containing the article 46 paediatric study results).
The CMDh agreed that the Best Practice Guide on Article 45 and 46 – Paediatric Regulation – EU Worksharing Procedure needs to be updated. An an update of the BPG and the cover letter will be prepared.
9. Zero day MR Procedures
The CMDh discussed the possibility for a CMS to accept a Zero Day MR Procedure request, while there is another procedure ongoing in the CMS for a similar product following a standard timetable.
- It was noted that, in most cases, it is the CMS that initiates the contact with possible MAHs in case of shortages or issues with access to critical medicines.
- However, most MSs confirmed that, in very exceptional and critical cases, they would accept the Zero Day MR Procedure in parallel of an ongoing procedure with full assessment.
10. Question & Answer on the need for bioequivalence studies with acid reducing agents (ARAs)
The CMDh was informed about the publication of a Q&A on the EMA website on the need for BE studies with acid reducing agents in situations where a generic product uses another salt/API form or different pH modifying excipient/technology than the reference medicinal product. The Q&A was developed by the PSBGL DG in relation to a previous CMDh request.
11. Usage patents
The CMDh discussed a request of an applicant of a generic product to amend the wording for the indication during the national phase in order to restrict the indication due to a national usage patent for the RefMP.
- The applicant proposed an addition to the wording of th indication that in principle leads to a restriction of the indication for certain populations (instead of a deletion of the indication).
- The CMDh agreed by majority that such modifications of the wording of the indication to exclude a patient population are not acceptable.
- This is in line with decisions taken in the past.
- In addition, the proposed modifications would currently be in conflict with information in other sections of the SmPC.
12. Handling of automated referrals in CTS
Following the CMDh agreement to start an automated referral in case the RMS switches its position from negative to positive after day 205 of a DCP (to allow CMS to raise PSRPH, as appropriate), it was noted that RMSs take different approaches on how the outcome is recorded in CTS (in case the automated referral is withdrawn).
- It was proposed that when an automated referral is triggered, the RMS fills in the Day 210 date in Procedure Outcome and marks the procedure with “CMD”.
- If the automated referral is withdrawn, the RMS will clear the box for CMD and instead mark “Accepted” as outcome, keeping the date for Day 210.
- The Day 210 date will also be kept in the End of Procedure template as “Date of approval / Day of procedure” as well as for calculating the common renewal date.
- In order not to lose record of the automated referral, it was further suggested to mention the automated referral in the annotation field in CTS.
- The CMDh agreed with the proposed approach.
- The CTS GPG will be updated accordingly.
- An update of CTS to provide a field to track automated referrals in the futur can be considered.
- It was noted that the End of procedure (EoP) template contains a tick box for the outcome referral to CMDh/disagreement among Member States.
- It was agreed that this tick box can be removed in the next revision of the template as in such a case the referral notification will be circulated instead of the EoP template. The EoP template will only be used in case of a positive outcome (agreement between Member States).
13. Mandatory use of variation worksharing
The CMDh discussed a query from a MAH (holding MAs for products with the same active substance authorised under Art. 8(3) and Art. 10(1)) if all MAs should be included in a type II variation worksharing procedure to implement safety updates triggered by internal signals or if the update should first be implemented via type II variation for the Art. 8(3)/RefMP MA and generic MAs should only be updated after approval of the change for the Art. 8(3) MA.
The CMDh agreed that all marketing authorisations for products containing the same active
substance owned by the same MAH belong to the same global marketing authorisation and (safety) updates should therefore be submitted to all MAs at the same time using variation
worksharing. A response will be sent.
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications
This document was last updated on 21 February 2025. Here, you can view the track changed (Dec 2024) and clean (Feb 2025) versions of the document.
The main changes in the document appear to be to the response to the following question.
2.3. When and how Rapporteur and Co-Rapporteur appointed? Rev. Feb 2025
Source: EMA
Guide for Change of Trial Sponsor
The CTCG provides this guide outlining the steps for Sponsors to follow and the expedited procedure for changing the sponsor legal entity (Org-ID). This change is a substantial modification per Annex IV of the CTR Q&A at EudraLex Volume 10.
Guide for Change of Trial Sponsor
Version 1 – February 2025
Source: HMA
Product Lifecycle Management Insights
27 January 2025
The issue with the above date has been published. It includes information on a range of topics including the following:
- IRIS Regulatory Procedure Management
- Electronic Product Information
- Product Management Service
- PMS updated roadmap and key actions for MAHs
Source: EMA
Clinical Trials Information System (CTIS) newsflash
11 February 2025
This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials. You can view it here. Included in this edition are the following topics:
- Get advice to improve your applications (CTAs and MAAs)
- Key updates for sponsors: end of CTR transition
- Tip for sponsors: End of trial notifications and substantial modifications
- System improvements
Source: EMA
Report from the CMDh meeting held on 28-29 January 2025
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
The report from the above meeting includes (but is not restricted to) the following items:
1. Template for Request for RMS in DCP
The CMDh agreed an update of the template for request for RMS in DCP.
- The document has been updated to include a field for the bioequivalence study number (as applicable) and a footnote to add the definition of the European Reference Medicinal Product.
- The declaration that no other Member State has agreed to become RMS for the procedure has been changed to a tick box and extended to pending requests.
- The updated document has now been published on the CMDh website under “Templates > Application for MA”.
- Here, you can view the track changed (Jun 2023) and clean (Jan 2025) versions of the document.
2. Procedural Advice on Repeat-Use
The CMDh agreed an update of the Procedural Advice on Repeat-Use.
- The main change is to align the guidance with the updated Best Practice Guide on Renewals.
- Other minor changes, in line with the experience gained, have been included.
- The updated document has now been published on the CMDh website under “Procedural Guidance > Application for MA > MRP/RUP”.
- Here, you can view the track changed (sept 2020) and clean (Jan 2025) versions of the document.
3. Questions and Answers on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
The CMDh together with the EMA has agreed an update of the joint EMA/CMDh Q&As on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746).
- The document has been updated to state that, when a Declaration of Conformity is not available, in certain cases (for class I (excluding Is and Im) medical devices), a MAH’s statement of compliance with the relevant general safety and performance requirements (GSPRs) of the MDR Annex I can be acceptable.
- The updated document has now been published on the EMA website. Here, you can view the track changed (3 May 2024) and clean (Jan 2025) versions of the document. (Source: EMA)
4. CMDh Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU reference date is not yet legally binding/followed
The CMDh agreed an update of the Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU reference date is not yet legally binding/followed as prepared by the Working Party on Pharmacovigilance Procedures Work Sharing.
- The update concerns a general revision of the guidance document and includes, among others, guidance and criteria for exceptional requests of an additional (ad hoc) PSUR upon request of an NCA (in accordance with Article 107c(2) of Directive 2001/83/EC as amended and as described in the GVP module VII section VII.C.3.3.4), i.e. outside of the scheduling or the DLPs set out in the EURD list.
- The updated document has now been published on the CMDh website under “Pharmacovigilance > PSUR > Informal PSUR Worksharing”.
- Here, you can view the track changed (May 2023)and clean (Jan 2025) versions of the document.
5. CMDh Best Practice Guides for the Submission and Processing of Variations in MRP (Chapter 3 and 6)
The CMDh agreed an update of Chapter 3 (Type IA Minor Variations (Notifications)) and Chapter 6 ((Super-)Grouped Applications) of the Best Practice Guides for the Submission and Processing of Variations in MRP.
- The main change to the BPGs is to include information that a justification for the exceptional submission of type IA variations outside of annual updates (listed in Chapter 6 of the BPG on variations) should be clearly indicated in the background/scope section of the eAF.
- An optional wording to be used has been included in the guidance documents.
- The updated documents have now been published on the CMDh website under “Procedural Guidance > Variation”.
- Here, you can view the track changed (Oct 2024) and clean (Jan 2025) versions of Chapter 3 CMDh BPG for the Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure
- Here, you can view the track changed (Oct 2024) and clean (Jan 2025) versions of Chapter 6 CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure.
6. CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity
The CMDh agreed an update of the SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity.
- As discussed previously and as is current practice, it has been reflected in the document that decisions on an additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh are published in a separate document (besides the CMDh minutes) and how the start date of the non-cumulative period of one year of data exclusivity for a new therapeutic indication granted under Article 10(5) should be calculated.
- The updated document has now been published on the CMDh website under “Procedural Guidance > Application for MA”.
- Here, you can view the track changed (June 2023)and clean (Jan 2025) versions of the document.
Overview of timetables 2025 CMDh 60-day procedures for MRP/DCP applications
You can view the timetable here.
PMS User Interface edit functionalities now available for users
The Product Management Service (PMS) User Interface (PUI) edit functionalities – live on the Product Lifecycle Management (PLM) portal – are now available for Industry users.
- Note that the write access is for now limited to:
- pack size and
- manufacturer data for non-Centrally Authorised Products* (non-CAPs).
- This data is required for the shortage reporting via the European Shortages Monitoring Platform (ESMP), which went live with full functionalities on 29 January 2025.
- Please consult this news article for full PMS roadmap and a recap of key current and future actions for MAHs.
Supporting events
You can obtain a timetable of the supporting webinars at the link below.
Source: eSubmission
Q&A Clinic on post authorisation procedure management transition to IRIS
You can view the EMA webinar with the above title held on 8 January 2025 here.
Source: EMA