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Scientific guidelines (human and veterinary)
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Latest posts
Last updated 3 days ago
Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes
3 days ago
Concept paper on the revision of the guideline on the Scientific Data...
Draft guideline on the quality aspects of mRNA vaccines
3 days ago
Draft guideline on the quality aspects of mRNA vaccines
ICH M11 Technical Specification - Updated step 2b
16 days 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
about 1 month ago
Draft guideline on the clinical investigation of medicinal products in the treatment...
Implementation strategy of ICH Guideline M12 on drug interaction studies
about 2 months ago
Implementation strategy of ICH Guideline M12 on drug interaction studies
Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
about 2 months ago
Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues
2 months ago
Draft reflection paper on the use of information in European Union herbal...
Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
2 months ago
Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
Draft reflection paper on the qualification of non-mutagenic impurities
2 months ago
Draft reflection paper on the qualification of non-mutagenic impurities
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
2 months ago
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance
3 months ago
Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg...
Draft concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use
3 months ago
Draft concept paper for the development of a guideline on quality aspects...