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GMP News

27.11.2025

USP: Proposals for Extractables & Leachables

The USP is expanding the Extractables and Leachables (E&Ls) chapter series <1664>. Following the previously published draft chapter for E&Ls in parenteral drug products three new drafts of USP's E&L chapters were just published in Pharmacopoeial Forum. The comment deadline is 31 January 2026.

27.11.2025

EMA/CMDh: Nitrosamines Q&A Document updated again

In October 2025, the 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", which was jointly created by the EMA and the CMDh, was updated and published in the new Revision 23 on the EMA website.

27.11.2025

Final ICH M14 Guideline on the Use of RWD for Safety Assessment

The European Medicines Agency (EMA) has published the ICH M14 guideline. With the publication of ICH M14, the EMA has issued the first internationally harmonised guideline for non-interventional studies aimed at obtaining real-world evidence on the safety of medicinal products.

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