Date of Publication: 20-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA), through its Committee for Veterinary Medicinal Products (CVMP), has released a draft guideline outlining the quality requirements for mRNA…
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: 19-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has published its updated pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026. The document provides outcomes…
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: 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Date of Publication: 11-Feb-2026 INTELLIGENCE OVERVIEWAgency: US FDAThe FDA has issued a revised Draft Guidance (Revision 2) outlining the updated certification process for Designated Medical Gases (DMGs) under 21 CFR…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,…