Last week’s round -up;
22-26 March 2021

published 29 Mar 2021

WHO/IAEA investigational radiopharmaceutical GMP draft guidance

The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) have released a draft guideline on GMP for investigational radiopharmaceuticals, due to the rapidly expanding use of radiopharmaceuticals to diagnose and treat cancers and other diseases. The draft guidance sets out the minimum GMP standards for Phase 1-3 clinical investigations of novel radiopharmaceuticals that are not yet authorized or approved. The draft guidance is open for public consultation until the end of April 2021, and a revised document is expected to be worked up for public consultation by July 2021.

EC-DG SANTE/HMA-CTFG/EMA joint training on the Clinical Trials Regulation (EU) 536/2014

The EC-DG Sante has published a raft of presentations from their recent training on 9th to 10th March 2021. The aim of the training was to provide an outline of the key changes which will apply under CTR.

Full details and all the presentations can be found here:

Nitrosamine Impurities in Sartans – Updates

The following updates concerning nitrosamine impurities in sartans are available: • Euro Roundup: EDQM clarifies implications of new sartan monographs for the holders of a currently valid Certification of Suitability (CEP). • CMDh Questions & Answers on implementation of outcome of Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (with tracked changes) • Rapid implementation of the revised sartan Ph. Eur. monographs (Valsartan, Losartan potassium, Irbesartan, Candesartan cilexetil and Olmesartan medoxomil) on 1 April 2021. • General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs.

The guidance listed above may be viewed at the following link:


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