GMP News - Regulatory Affairs

05.04.22

MHRA GCP Inspector´s Experience during the COVID-19 Pandemic

The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.

more

05.04.22

Recent Findings in GCP Inspections

The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.

more

05.04.22

Version 5 of the Q&As regarding the Clinical Trials Regulation

What is the final deadline for submission of a clinical trial according to the former CTD rules? The European Commission published an updated Version 5 of the Questions & Answers relating to the CTR which came into application on 31 January 2022. The revision includes new Q&As regarding arrangements for the transitional period.

more

05.04.22

EMA: Update of the "IRIS Guidance Documents"

Both the "IRIS guide to registration and RPIs" and the "IRIS guide for applicants" were updated in February and published on the EMA website.

more

05.04.22

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.

more

23.03.22

EDQM: CEP Application Templates redesigned

Due to the introduction of new IT systems, the EDQM has now also adapted the forms for applying for new CEPs, changes to CEPs and so-called "sister files" and plans to implement them on 01 April 2022.

more

16.03.22

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?

more

16.03.22

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).

more

16.03.22

Update on Quality Topics for Herbal Drugs

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.

more

15.03.22

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.

more

15.03.22

Remote Data Acquisition in Clinical Trials

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?

more

09.03.22

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.

more

09.03.22

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.

more

24.02.22

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).

more

24.02.22

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.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics