News Archive

EMA - key recommendations in 2021 on the authorisation and safety monitoring of medicines for human use.

16th February 2022

EMA has published an overview of its key recommendations in 2021 on the authorisation and safety monitoring of medicines for human use.

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EMA - CTIS Bitesize Talks

15th February 2022

In 2022, EMA will offer short talks for clinical trial sponsors focused on CTIS functionalities.

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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).

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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.

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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®)

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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.

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