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MHRA - Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems

19th October 2022

Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems

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MHRA - annual accountability review minutes

19th October 2022

The minutes of the ministerial annual accountability review of the Medicines and Healthcare products Regulatory Agency (MHRA).

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MHRA - Quarterly Summary Reports added to Medical Device Guidance

29th September 2022

Quarterly Summary Reports added to Medical Device Guidance

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MHRA - Advertising and Promotion Section added to NIMAR

29th September 2022

MHRA have added an 'Advertising and Promotion' Section added to NIMAR

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MHRA - first new UK Approved Body to certify medical devices since Brexit appointed

29th September 2022

MHRA appoints first new UK Approved Body to certify medical devices since Brexit

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EC - Adoption of revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR)

28th September 2022

The European Commission (EC) have adopted the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR)

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022

28th September 2022

EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022

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EMA - Veterinary Medicines Regulation Highlights.

28th September 2022

The latest edition of the Veterinary Medicines Regulation Highlights.

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EMA - biosimilar medicines approved in the European Union (EU) are interchangeable

28th September 2022

EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.

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FDA - Answers to GCP Questions

28th September 2022

FDA have published an Excel sheet of answers to some GCP questions.

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