News Archive

MHRA - New year, new standards for investigational medicines

15th February 2022

New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human use (more commonly known as the revised Annex 13 of EU GMP).

Read More+

MHRA - Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned

15th February 2022

In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the unprecedented challenges we faced in each area and the lessons we have learned during the last two years.

Read More+

EMA - Launch of the establishment phase of DARWIN EU® and the initiation of the Coordination Centre

10th February 2022

EMA is initiating the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®)

Read More+

A faster path to UK trials approvals: CTIMP review service launches

9th February 2022

In this joint blog, Catherine Blewett, Senior Development Manager at the HRA, and Martin O’Kane, Head of the MHRA Clinical Trials Unit, fill us in on the new process, which will lead to faster approvals.

Read More+