Last updated: 29 August 2024
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Management of rapid alerts arising from quality defects risk assessment
The document with the above title was adopted on 15 June 2024 and came into forse on 1 August 2024. You can view it here.
Source: EMA
Questions and Answers Document – Regulation (EU) 536/2014 on clinical trials
The document with the above title has been updated. You can view the latest Version 6.9 of July 2024 here. The updates from the previous version are listed on page 2 of the document.
Source: European Commission
Updates to Guidelines on good pharmacovigilance practices (GVP)
The following guidelines have been updated and update details are provided at the beginning of each document.
Source: EMA
Report from the CMDh meeting held on 23-24 July 2024
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. Active Substance Master File worksharing
Further to the update of the document “The worksharing procedure for the assessment of Active Substance Master File (ASMF)”, the CMDh agreed an update of the “EU ASMF number request form”.
- The main change is the request for additional information to check the eligibility of already approved ASMFs (with an assessment history of at least 2 years) to be included in the ASMF worksharing procedure.
- The template has been published on the CMDh website under “CMD Working Parties/Working Groups > WG on ASMF procedures”.
- Here, you can view the track changed (Oct 2020)and clean (July 2024) versions of the form template.
2. IRIS platform
For all EMA led post authorisation procedures (including procedures involving NAPs, e.g. PSURs, PASS, Referrals, etc.) starting from January 2025 IRIS registration is mandatory. The EMA therefore kindly requests MAHs to check that their procedure contact person has an IRIS account.
- Access can be requested via EMA Account Management System following the instructions available in the IRIS guide for registration and RPIs;
- Useful resources:
- IRIS user guide for applicants
- 13 June 2024 RPM update webinar for MAHs (presentation and recording available on event page)
- Industry RPM FAQ Document
Managing regulatory procedures in IRIS is part of EMA strategy to deliver an end-to-end data-driven process from submission to post-authorisation.
- This transition will enhance automation and efficiency, improve knowledge management and data security, and increase transparency.
- Additionally, it will simplify and standardise processes for MAHs, facilitating the decommissioning of SIAMED (the current EMA case management system).
2024 January-June- Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
You can view the stats in this slide deck.
Requirements on submissions for Variations and Renewals within MRP and National Procedures
The requirements document has been updated. Here, you can view the track changed (Jan 2022) and clean (July 2024))versions of the document.
Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures
The requirements document has been updated. Here, you can view the track changed (Jan 2022) and clean (July 2024) versions of the document.
Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers
This table has been updated. Here, you can view the track changed (May 2024) and clean (August 2024) versions of the table.