News Archive

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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MHRA guidance on Coronavirus (COVID-19)

25th March 2020

The MHRA are producing guidance for industry covering the Coronavirus (COVID-19) outbreak. Quite a few updates today.

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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

25th March 2020

This guidance provides recommendations to industry regarding post marketing adverse event reporting for drugs, biologics, medical devices, combination products,2 and dietary supplements during a pandemic.

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Turning pharma green: an eco-wish list for the industry

25th March 2020

An interesting article: The reality of climate change is hard to ignore. As one of the biggest polluters, and simultaneously the industry tasked with trying to tackle the global health outcomes of environmental degradation, pharma has a responsibility to be more eco-friendly. Allie Nawrat compiles an eco-wish list of how this global industry can make its activities more sustainable.

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Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU

18th March 2020

The EU (EMA, the European Commission and national competent authorities in the Member States) have organised the first meeting of the EU Executive Steering Group on shortages of medicines caused by major events to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU.

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