News Archive

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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Annual overview of the involvement of patients and healthcare professionals in the work of the EMA

17th March 2020

Public engagement highlights - Annual overview of the involvement of patients and healthcare professionals in the work of the European Medicines Agency (EMA)

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NIH clinical trial of investigational vaccine for COVID-19 begins

16th March 2020

A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today.

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MHRA Advice for Management of Clinical trials in relation to Coronavirus

12th March 2020

MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials....

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ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management

11th March 2020

Current version adopted 4th March 2020.

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MHRA Blog Post: GCP Inspections: Expectations and the dos and don’ts for hosting

11th March 2020

GCP Inspections: Expectations and the dos and don’ts for hosting

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Call for a MRA on GMP in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations

4th March 2020

Three European Industry Associations (EFPIA, Medicines for Europe and AESGP) have published 'Call for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations'.

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