GMP News - Regulatory Affairs

The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.

In March 2024, the "Questions & Answers (Q&A)" documents relating to centralised procedures were again updated and published on the website of the European Medicines Agency (EMA).

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

The MHRA published guidance updates on how to notify the MHRA about changes to the Pharmacovigilance (PV) system. The revisions came into effect on 11 May 2023 and have been updated on 17 November 2023.

The first version of the document "Quality Agreement Guideline & Template" was published in 2009, updated in 2017 and has now been revised again. Version 3 of the guideline was published in January 2024 and is now available on the APIC website in the "Publications" tab.

The nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.