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News Archive
Public Consultation - Declaration of Helsinki
8th February 2024Phase I period for public consultation now open.
EMA - EMA to support establishment of the African Medicines Agency
7th February 2024EMA 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.
EMA - New platform for collection of sales and use data of antimicrobials in animals
7th February 2024EMA 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.
EMA - Transition to the Clinical Trials Information System (CTIS) by 31 January 2025
7th February 2024All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
EMA - Veterinary medicines: Highlights of 2023
7th February 2024On 24 January 2024 EMA published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.
FDA - GMP for APIs Used in Veterinary Medicinal Products
7th February 2024CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products Draft released and open for comments.
FDA - Roundup, 6th February 2024
7th February 2024An at-a-glance summary of news from around the agency
MHRA - updates on to how to notify the MHRA of changes to the PV System
7th February 2024Guidance updates on to how to notify the MHRA of changes to the PV System
Union Health Ministry (India) notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945
7th February 2024The revised Schedule M prescribes the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products; official says this will ensure Indian guidelines are at par with global standards.
EMA - New Q&As on EU GMP Guide Annexe
2nd February 2024Annex 1: Manufacture of sterile medicinal products
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