News Archive

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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MHRA - Updated CAPA Guidance

28th September 2022

MHRA have updated the CAPA guidance PDF on 27th September.

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