GMP News - Regulatory Affairs

Now that the ICH Q 12 Guideline on Pharmaceutical Product Life Cycle Management has also been implemented in the US, guidance on the subject is following. In a new guideline "Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA", combination products are also addressed.

The "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures, last revised in June, have now been updated again and published on the European Medicines Agency (EMA) website. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and to provide answers to potential questions at different stages of the centralised marketing authorisation application process.

The EMA published the ICH M11 draft Guideline on the Clinical Electronic Structured Harmonized Protocol (CeSHarP) for comments. The comment period runs until February 26, 2023.

In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.

Since the beginning of September 2022, the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" has been published for comments on the USP Pharmacopeial Forum website. Comments and observations on this draft can be submitted until 30 November 2022.

The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.