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Scientific guidelines (human and veterinary)

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Last updated 1 day ago

Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products

1 day ago

Concept paper on the revision of Part IV guidelines on good manufacturing...

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Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b

9 days ago

Draft ICH Q1 guideline on stability testing of drug substances and drug...

Read full

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

about 1 month ago

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms...

Read full

Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes

about 1 month ago

Concept paper on the revision of the guideline on the Scientific Data...

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Draft guideline on the quality aspects of mRNA vaccines

about 1 month ago

Draft guideline on the quality aspects of mRNA vaccines

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ICH M11 Technical Specification - Updated step 2b

about 2 months ago

ICH M11 Technical Specification - Updated step 2b

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Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

2 months ago

Draft guideline on the clinical investigation of medicinal products in the treatment...

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Implementation strategy of ICH Guideline M12 on drug interaction studies

3 months ago

Implementation strategy of ICH Guideline M12 on drug interaction studies

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Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance

3 months ago

Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance

Read full

Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues

3 months ago

Draft reflection paper on the use of information in European Union herbal...

Read full

Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml

3 months ago

Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml

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Draft reflection paper on the qualification of non-mutagenic impurities

3 months ago

Draft reflection paper on the qualification of non-mutagenic impurities

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Scientific guidelines (human and veterinary)

Latest posts

Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products

Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes

Draft guideline on the quality aspects of mRNA vaccines

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

Implementation strategy of ICH Guideline M12 on drug interaction studies

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

Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml

Draft reflection paper on the qualification of non-mutagenic impurities

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