GMP News - Regulatory Affairs

A quick guide on the main rules and procedures of the Clinical Trials Regulation (CTR) has been released for sponsors who wish to conduct clinical trials in the European Union (EU) / European Economic Area (EEA) or have ongoing clinical trials in this region.

On 31 January 2023 the Clinical Trials Information System has become mandatory for EU clinical trial applications. However, there are still some issues regarding the functionality of the CTIS. Now, the European Commission, together with the EMA and the HMA, published the results of a consultation on the implementation of the CTR.

The EU Commission and the UK government have reached an agreement on special arrangements for Northern Ireland (the so-called "Windsor Framework"). Part of it is also a possible solution for medicines.

On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at regular intervals. It indicates which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances (since January 2023) or will be deleted in the future (as of April or July 2023).

The European Directorate for the Quality of Medicines published a new chapter 5.1.13. PYROGENICITY, dealing with testing for pyrogens, for comment.

From 20 March 2023, Swissmedic will issue CPPs in the new WHO format. No CPP orders can be accepted during the transition to the new format.

The EDQM (European Directorate for the Quality of Medicines & HealthCare) has adopted the document "Management of CEP guidelines and operational documents for the CEP procedure" by the end of 2022 and has now published it on its website. This document explains the new process for the development of supporting documentation related to CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia).