News Archive

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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EMA - Human Medicines Highlights Newsletter 168

26th April 2023

Key information for patients, consumers and healthcare professionals.

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EMA - PRAC 11-14 April 2023

26th April 2023

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023

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EMA - Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines

26th April 2023

On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines.

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EMA - Single-arm trials as pivotal evidence for the authorisation of medicines in the EU

26th April 2023

EMA has opened a public consultation on a PDF icon reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).

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