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News Archive
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.
EMA - Highlights CVMP 16-17 Jan 2024
24th January 2024Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17 January 2024
FDA - Roundup 23rd Jan 2024
24th January 2024An at-a-glance summary of news from around the agency.
EMA - Human medicines: highlights of 2023
18th January 2024In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent.
EMA - Meeting Highlights PRAC 8th - 11th Jan 2024
18th January 2024Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
FDA Roundup: 16th January, 2024
18th January 2024An at-a-glance summary of news from around the agency.
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