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Scientific guidelines (human and veterinary)
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Last updated about 5 hours ago
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials
about 4 hours ago
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I –...
Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations
about 9 hours ago
Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6...
Draft reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in children and adolescents
about 10 hours ago
Draft reflection paper on data recommendations for herbal medicinal products and traditional...
Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets
10 days ago
Concept paper on the development of a guideline on consumer safety of...
Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products
25 days ago
Concept paper on the revision of Part IV guidelines on good manufacturing...
Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b
about 1 month ago
Draft ICH Q1 guideline on stability testing of drug substances and drug...
ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b
about 2 months ago
ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms...
Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes
2 months ago
Concept paper on the revision of the guideline on the Scientific Data...
Draft guideline on the quality aspects of mRNA vaccines
2 months ago
Draft guideline on the quality aspects of mRNA vaccines
ICH M11 Technical Specification - Updated step 2b
3 months ago
ICH M11 Technical Specification - Updated step 2b
Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
3 months ago
Draft guideline on the clinical investigation of medicinal products in the treatment...
Implementation strategy of ICH Guideline M12 on drug interaction studies
4 months ago
Implementation strategy of ICH Guideline M12 on drug interaction studies