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Scientific guidelines (human and veterinary)
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Last updated 11 days ago
Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application
11 days ago
Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal...
Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)
17 days ago
Questions and answers regarding co-processed excipients used in solid oral dosage forms...
Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1
19 days ago
Draft guideline on clinical development of medicinal products for the treatment and...
ICH guideline E11A on pediatric extrapolation Step 5
about 1 month ago
ICH guideline E11A on pediatric extrapolation Step 5
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
about 2 months ago
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate realworld evidence, with a focus on effectiveness of medicines
about 2 months ago
ICH reflection paper on pursuing opportunities for harmonisation in using real-world data...
Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats
2 months ago
Concept paper on the revision of the guideline on dossier requirements for...
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance
2 months ago
Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350...
Concept paper on the revision of the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees
2 months ago
Concept paper on the revision of the guideline on veterinary medicinal products...
Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/2000-Rev.4)
2 months ago
Concept paper for the revision of the guideline on the conduct of...
Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)
2 months ago
Concept paper on the revision of the guideline on user safety for...
Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance
2 months ago
Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and...