News Archive

MHRA Blog Post: Reference Safety Information (RSI) for Clinical Trials- Part III

5th February 2021

Since RSI blog posts part I and II were released, the MHRA GCP inspectorate has continued to see non-compliance in this key aspect of pharmacovigilance. Whilst additional guidance was released by the Heads of Medicines Agencies, Clinical Trials Facilitation and co-ordination Group (CTFG), we are still seeing unreported suspected unexpected serious adverse reactions (SUSARs) and absence of adequate risk mitigation measures due to incorrect use of the RSI.

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EU Commission - Brexit Notice on Medicinal Products

3rd February 2021

The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021 entitled "Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2021/C 27/08)".

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EU Commission - New Health Authority - feedback open

3rd February 2021

European Health Emergency Preparedness and Response Authority (HERA) - New health authority

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MHRA - Pharmacovigilance requirements for UK authorised products - 13 January 2021

30th January 2021

Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.

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NHS HRA - Public Involvement in an Pandemic

28th January 2021

An interesting article by the NHS HRA - Public involvement in a pandemic: lessons from the UK COVID-19 public involvement matching service.

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NHS HRA - Trial Design Podcast Series Now Available

28th January 2021

New podcast series looks at innovation in trial design and study delivery during the COVID pandemic

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NHS Health Research Authority - HRA Now Newsletter

28th January 2021

HRA are launching HRA Now - a new way to share the changes that researchers and R&D professionals need to know about.

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EMA - Human medicines and Veterinary: highlights of 2020

27th January 2021

EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human and veterinary use.

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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021

27th January 2021

CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025 CVMP opinions on veterinary medicinal products

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EMA - Updated Timeline for the Clinical Trial Regulation

27th January 2021

The European Medicines Agency, EMA, is still planning with December 2021 for the go-live date of the EU Clinical Trials Information System (CTIS) database and portal, and thus with the first application of the Clinical Trial Regulation (CTR, Regulation (EU) No 536/2014).

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