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.


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.


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.


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.


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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