News Archive

EMA - Revised transparency rules for the EU Clinical Trials Information System (CTIS)

6th October 2023

EMA has adopted PDF icon revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System. The simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way.

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EMA Management Board: highlights of October 2023 meeting

6th October 2023

EMA Management Board: highlights of October 2023 meeting

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

20th September 2023

Held 5-7 September 2023

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EMA - Accelerating clinical trials in the European Union (ACT EU) initiative website

20th September 2023

EMA is pleased to inform you that a website has been launched for the Accelerating clinical trials in the European Union (ACT EU) initiative, co-led by the European Commission, the Heads of Medicines Agencies and the European Medicines Agency.

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EMA - CTIS newsflash

20th September 2023

15 September 2023

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EMA - Human Medicines Highlight Newsletter

20th September 2023

Edition 173

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

20th September 2023

Held 11-14 September 2023

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FDA - FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive Agenda

20th September 2023

The FDA announced it is taking new steps to further modernise its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase regulatory flexibility, predictability and efficiency.

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FDA - Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products

20th September 2023

Guidance for IRBs and Clinical Investigators released September 2023

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FDA - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

20th September 2023

FDA releases guidance document

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