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The 'Reflection paper on the qualification of non-mutagenic impurities' was published on the EMA website at the beginning of February 2026. It is intended to supplement the existing guidelines for non-mutagenic impurities (NMI) with regard to qualification and safety assessments.

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In December 2025, updated documents on the topic "Variations" were published on the HMA/CMDh website. These include, for example, Chapter 7 "CMDh BPG on Variation Worksharing" of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" and the "EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only."

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In March 2025, the FDA identified serious GMP deficiencies during an inspection of a US manufacturer of sterile OTC products and contract testing laboratories. After the manufacturer's response to the Form 483 report was deemed insufficient, a Warning Letter was issued.

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In January 2026, the Q&A document 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)' was finally published on the EMA website.

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In December 2025, the "Questions & Answers (Q&A)" document relating to centralized authorization procedures was updated again and published on the website of the European Medicines Agency (EMA). The updates and changes mainly relate to chapters 2 and 5 of the list of questions "European Medicines Agency pre-authorization procedural advice for users of the centralized procedure."

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Version 4.0 of the technical interpretation on legal requirements for foreign trade and supply chain traceability defines concrete and enforceable obligations.

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During an inspection of a US OTC manufacturer in June 2026, the US FDA identified a significant risk of cross-contamination between pharmaceutical and non-pharmaceutical production and issued a Warning Letter.

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In November 2025 and January 2026, the 'IRIS guide for applicants' was revised again and published in its updated version. Version 3.12 is now available on the EMA website.

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During an inspection of a US manufacturer of terminally sterilised medicinal products, the FDA identified numerous GMP deficiencies. The key issues were inadequate handling of OOS results in endotoxin testing and significant technical and hygienic deficiencies in cleanrooms and equipment.

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Get a clear, structured overview of how GMP inspections are conducted in the EU and by the US FDA - from preparation and execution to reporting and regulatory outcomes.

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