Date of Publication: 20-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has released Revision 3 of its guideline on risk management requirements for elemental impurities in veterinary medicinal products. This…
Date of Publication:13-Feb-2026 INTELLIGENCE OVERVIEWThe European Medicines Agency (EMA) has released a concept paper proposing the development of a dedicated guideline for the clinical investigation of medicinal products in the…
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Date of Publication: 11-Feb-2026 INTELLIGENCE OVERVIEWAgency: US FDAThe FDA has issued a revised Draft Guidance (Revision 2) outlining the updated certification process for Designated Medical Gases (DMGs) under 21 CFR…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 (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…