News Archive

Swissmedic - Interpretation of Annex 1

22nd November 2023

This technical interpretation focuses on some of the most important main changes of the revision 2022 of Annex 1 and also covers aspects that were already included in the previous version of this guideline and that repeatedly gave rise to questions.

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EMA - Veterinary Papers Released for Public Consultation

16th November 2023

Comments by 31st January 2024

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023

13th November 2023

Meeting highlights

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EMA - CTIS newsflash

13th November 2023

10th November 2023

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EMA - Call for expression of interest for independent scientific experts to participate in the work of EMA’s Safety Committee

13th November 2023

The European Commission is launching a selection procedure to appoint independent scientific experts to EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Six experts will be appointed for a three-year mandate starting on 2 July 2024.

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EMA - Global regulators celebrate 10 years of strategic leadership and cooperation

13th November 2023

This year marks the 10th anniversary of the International Coalition of Medicines Regulatory Authorities (ICMRA).

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EMA - Human Medicines Highlights Oct 2023

13th November 2023

Issue 174

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

13th November 2023

6-9 November 2023

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)

13th November 2023

7-9 November 2023

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FDA - Benefit-Risk Assessment for New Drug and Biological Products

13th November 2023

The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA's regulatory decisions.

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