News Archive

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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New MHRA Blog Post: Remote working and QP certification

26th February 2020

In the modern world it is increasingly common to see flexible, part-time or home working arrangements. Digital connections can allow us to continue to work effectively when we are away from the office. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.

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Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4

20th February 2020

Period of consultation From 20 February 2020 to 20 May 2020. Objective of the consultation Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients. Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.

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EMA - How does EMA support SMEs?

12th February 2020

A new video on how the EMA supports small and medium enterprises.

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EMA Consultation - Reflection Paper on GMP and MAHs

12th February 2020

The European Medicines Agency has released for public consultation the reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.

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