Date of Publication: 09-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has released a Concept Paper outlining plans to revise Annex 15 of the EU Good Manufacturing Practice (GMP) guidelines,…
TITLE: EMA Publishes UPD Registration Guide for UI & API UsersDATE: 02-Feb-2026DESCRIPTION: The European Medicines Agency (EMA) released an updated Union Product Database (UPD) registration guide to support UI and…
Date of Publication: 02-Feb-2026 INTELLIGENCE OVERVIEW Agency: EMA The European Medicines Agency (EMA) has released updated guidance on the registration process for users accessing the Union Product Database (UPD). This…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW The U.S. FDA has issued an Emergency Use Authorization (EUA) to support efforts against the New World screwworm outbreak affecting cattle. The authorization enables…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW Agency: US FDA The U.S. FDA has updated the safety labeling for Capecitabine to strengthen warnings related to Dihydropyrimidine Dehydrogenase (DPD) deficiency. The update…
INTELLIGENCE OVERVIEW The U.S. FDA has issued guidance on Computer Software Assurance (CSA) for Production and Quality Systems, introducing a risk-based, critical-thinking approach to software validation in the pharmaceutical and…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW The U.S. Food and Drug Administration (FDA) has announced its intent to take regulatory action against non-FDA-approved GLP-1 drug products, including certain compounded versions…
Date of Publication: 05-Feb-2026 (Official Gazette) INTELLIGENCE OVERVIEW Agency: Ministry of Health & Family Welfare – India/ The Gazette of India The Ministry of Health and Family Welfare (MoHFW), India,…
Date of Publication: 02-Feb-2026 INTELLIGENCE OVERVIEW Agency: Central Drugs Standard Control Organization - India/ Ministry of Health & Family Welfare - India The Ministry of Health and Family Welfare (MoHFW),…
Date of Publication (Latest update): 05-Feb-2026 INTELLIGENCE OVERVIEW The European Medicines Agency (EMA) has published an updated data protection notice for EudraVigilance (Human), clarifying how personal data are processed within…