News Archive

EMA Regulatory Science to 2025

1st April 2020

EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated so that we can adapt our process in real-time, where needed. The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary. The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.

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Advice for Good Laboratory Practice facilities in relation to coronavirus (COVID-19)

31st March 2020

MHRA Blog Entry: It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.

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Health Research Authority (NHS) - News

31st March 2020

Important updates about health research during the COVID-19 pandemic.

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Links from COVID-19 Webinar held on 31st March 2020

31st March 2020

Please find the links from the recent webinar on COVID-19, held at 1pm (BST) on 31st March 2020.

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Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

30th March 2020

Key changes from v1 (20-03-2020): additional clarification on obtaining informed consent; link to methodological guidance on statistical considerations in relation to COVID-19 pandemic; advice on IMP stocks, safety reporting, conduct of audits; temporary halts

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New advice to support mental health during coronavirus outbreak

30th March 2020

People struggling with their mental health during the coronavirus (COVID-19) outbreak will be offered additional online support and practical guidance to help them cope. RQA have also produced an infographic here to provide some tips.

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Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

30th March 2020

Due to the urgency, this guidance is issued with a 4-week public consultation. It should be noted that due to the rapidly evolving situation further updates to this guidance are possible and likely.

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Covid-19: FDA Postpones Domestic and Foreign Inspections

26th March 2020

In response to the COVID-19 outbreak, the U.S. Food and Drug Administration FDA has decided to postpone most foreign inspections until the end of April.

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EU GMP Annex 21 published

26th March 2020

On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled 'Importation of medicinal Products'. Consultation phase is 20 March 2020 to 20 June 2020. The deadline for coming into operation still needs to be determined.

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COVID-19 - MHRA

25th March 2020

The MHRA have put a lot of links on about inspections during these unprecedented times, here is the latest. We have also put together a COVID-19 Discussion Forum so everyone can discuss and share information related to working during this time.

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