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FDA - Use of Data Monitoring Committees in Clinical Trials

14th February 2024

Draft guidance, Feb 2024.

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MHRA - The first steps towards a new framework for medical devices in the UK

14th February 2024

Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK

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MHRA Pharmacovigilance Symposium 2024

14th February 2024

28 February 2024

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Public Consultation - Declaration of Helsinki

8th February 2024

Phase I period for public consultation now open.

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EMA - EMA to support establishment of the African Medicines Agency

7th February 2024

EMA will harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network. EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors.

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EMA - New platform for collection of sales and use data of antimicrobials in animals

7th February 2024

EMA has just launched the new Antimicrobial Sales and Use (ASU) Platform to support the collection of data by Member States on the sales and use of antimicrobials in animals.

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EMA - Transition to the Clinical Trials Information System (CTIS) by 31 January 2025

7th February 2024

All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.

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EMA - Veterinary medicines: Highlights of 2023

7th February 2024

On 24 January 2024 EMA published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.

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FDA - GMP for APIs Used in Veterinary Medicinal Products

7th February 2024

CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products Draft released and open for comments.

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FDA - Roundup, 6th February 2024

7th February 2024

An at-a-glance summary of news from around the agency

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