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News Archive
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
MHRA - two new UK Approved Bodies to certify medical devices
2nd February 2024MHRA announces two new UK Approved Bodies to certify medical devices
EMA - Major update of the SME user guide
24th January 2024The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.
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