GMP News

UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.

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Rapid Revision and Implementation of Pharmacopoeial Monographs Concerning 5 Sartan Preparations

In the light of the recommendations made in CHMP's final assessment report on nitrosamine impurities in sartan preparations, the European Pharmacopoeia Commission has revised 2 general chapters and 5 API monographs in a rapid procedure. Read more here about which new requirements are specified in the updated sartan monographs.

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MHRA starts combined Distant / On-Site Inspections

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is launching a sensible and likely workable approach to resuming domestic inspections - a combination of distant and on-site inspections.

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Post-Authorization Safety Studies - Recent Inspection Findings

The MHRA recently published inspection findings in the conduct of post-authorization safety studies (PASS). In particular, the agency observed significant breaches of the study protocol for the MAHs non-interventional PASS during inspection at a study site.

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How to Classify Changes to Ongoing Clinical Trials

The European Commission published an updated Version 3 of the Questions & Answers relating to the Clinical Trials Regulation. Amongst others, the new version covers the classification of changes to ongoing clinical trials.

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