News Archive

MHRA new guidance to help applicants and shorten timeframes for assessment of established medicines

29th February 2024

Process changes from 1 March 2024 build on measures already implemented by the agency

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Animal and Veterinary - Consultations Open Now

26th February 2024

EMA consultations open for comment now.

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VICH - GMP for API GL60 open for consultation

26th February 2024

GMP for API

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FDA - Conducting Remote Regulatory Assessments Q&A

14th February 2024

Draft guidance, Released January 2024.

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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Draft guidance, Feb 2024.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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