GMP News - Regulatory Affairs

In March 2022, the European Medicines Agency (EMA) published on its website the updated and revised version of the "Questions & Answers (Q&A)" document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" regarding centralised procedures.

Following the start of the application of the EU CTR on 31 January 2022, the MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Will the UK align with the EU CTR requirements, e.g. regarding labelling of IMPs?

EMA´s HMPC published the HMPC Work plan for 2022. Amongst others, the HMPC plans to establish a Guidance on New Manufacturing Techniques addressing, for example, supercritical CO2-extracts.

The FDA provides recommendations for sponsors, investigators, and other interested parties on the use of digital health technology for remote data acquisition in clinical trials. What is required regarding software validation and electronic documents?

The EDQM has published a new public document on the relationship between marketing authorisation holders/applicants and CEP holders. Here you can find out which duties and responsibilities a CEP holder has to fulfil towards his clients.

A new version of the "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation" was prepared in December 2021 and has now been published on the HMA (Heads of Medicines Agencies) website. This document is intended to serve as a supporting guide for the preparation of the electronic application form for the submission of medicinal products for human use and for the registration of traditional herbal medicinal products.

The reflection paper on the use of interactive response technologies (IRT) has been updated in view of the entry into application of the EU Clinical Trials Regulation (CTR) on 31 January 2022. It clarifies that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the CTR.