Date of Publication: 12-Feb-2026 INTELLIGENCE OVERVIEWThe European Medicines Agency (EMA) has issued guidance for applicants on the preparation of the “Precise Scope” section within variation application forms. This section plays…
Date of Publication: 10-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting held on 24–27 November 2025. The document…
Date of Publication: 11-Feb-2026 INTELLIGENCE OVERVIEWAgency: US FDAThe FDA has issued a revised Draft Guidance (Revision 2) outlining the updated certification process for Designated Medical Gases (DMGs) under 21 CFR…
Date of Publication: 09-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has published its recommendations and safety signals adopted at the 12–15 January 2026 meeting, providing…
Date of Publication: 09-Feb-2026 INTELLIGENCE OVERVIEWAgency: AEMPS (Spain)/EMAThe European Medicines Agency (EMA) has published the January 2026 Bulletin of the Committee for Medicinal Products for Human Use (CHMP), outlining key…
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…