Centralised Procedures: Update of the Q&A Document
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.
UK: Public Consultation on new Clinical Trials Legislation and Impact on IMPs
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?
Will there be an EU Herbal Monograph for Cannabis?
EMA´s HMPC announced the start of several activities relating to regulatory requirements and standards for medical cannabis. Amongst others, the HMPC will establish some basic information regarding existing standard requirements for herbal medicinal products (HMPs).
Updated Guidance relating to Clinical Trials during the COVID-19 Pandemic
The Guidance on the management of clinical trials during the COVID-19 Pandemic has been updated. The key changes are relating to updates with references to the EU Clinical Trials Regulation (CTR) which entered into application on 31 January 2022.
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?
Herbal Drugs: Concept Paper on GACP Revision Published
EMA´s HMPC published the concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin. Amongst others, the revision will address the need for clarification regarding GMP vs GACP.
Information Duties and Responsibilities of CEP Holders - the new EDQM Public Document
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.
Variation Application Form: Revision of the "Explanatory Notes"
The updated version of the "EMA/CMDh explanatory notes on variation application form (Human medicinal products only)" 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 supportive guide for the submission of the variations application form (specifically for human medicinal products).
CMDh: Adjustments to the Guide for Electronic Submissions (eAF)
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.
PIC/S revises GMP guide to reflect EU Clinical Trials Regulation
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its GMP guide to reflect the EU Clinical Trials Regulation, which became applicable on 31 January 2022. In addition, a new PIC/S Annex 16 on the certification by the authorized person and batch release has been included.