News Archive

MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

10th May 2023

The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These are anticipated to reach Step 2 soon and will be available for public consultation.

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MHRA - Implementation of the Future Regulations

10th May 2023

The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.

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MHRA - Publication Scheme

10th May 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to making transparency and accountability to the public a fundamental principle of how we do business.

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MHRA Blog - Ensuring Child Vaccine Safety at Every Step

10th May 2023

Shiva Ramroop, discusses how we ensure the safety of vaccines for children in the UK.

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Swissmedic - Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers

10th May 2023

Clarification of the requirements for the submission of audit reports

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MHRA - Good Distribution Practice Symposium 2023

2nd May 2023

Held on 21-22 February 2023 - here is write up of the event.

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EMA - CHMP Highlights 24 - 26 April 2023

27th April 2023

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023

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EMA - CVMP Meeting Highlights 18-20 April 2023

26th April 2023

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023

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EMA - CTIS newsflash – 21 April 2023

26th April 2023

This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.

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EMA - Clinical Trials Highlights 14

26th April 2023

April 2023 issue of Clinical Trials Highlights.

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