Date of Publication: 04-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has released a draft guidance on the conduct of clinical trials during public health emergencies, published on 27 February…
Date of Publication: 04-Mar-2026 INTELLIGENCE OVERVIEWAgency: Health Sciences Authority - SingaporeThe Health Sciences Authority (HSA), Singapore has released an updated guidance document titled “SG-HSA eCTD Specification and Guidance for Use…
Date of Publication: 02-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA), through its Committee for Medicinal Products for Human Use (CHMP), adopted a draft concept paper (EMA/CHMP/30023/2026) for public consultation…
Date of Publication: 23-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has published an updated list of reference documents supporting electronic safety reporting to the EudraVigilance system. This resource outlines…
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: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Date of Publication: 11-Feb-2026 INTELLIGENCE OVERVIEWAgency: US FDAThe FDA has issued a revised Draft Guidance (Revision 2) outlining the updated certification process for Designated Medical Gases (DMGs) under 21 CFR…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,…