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Scientific guidelines (human and veterinary)
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Last updated 1 day ago
Draft guidance on the conduct of clinical trials during public health emergencies
1 day ago
Draft guidance on the conduct of clinical trials during public health emergencies
Draft concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products
3 days ago
Draft concept paper on the development of a reflection paper on the...
Draft guideline on quality aspects of mRNA vaccines for veterinary use
13 days ago
Draft guideline on quality aspects of mRNA vaccines for veterinary use
Concept paper for the revision of the guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021)
21 days ago
Concept paper for the revision of the guideline on veterinary good pharmacovigilance...
Concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of Myasthenia Gravis
21 days ago
Concept paper on the need of a guideline on clinical investigation of...
ICH M15 Guideline on general principles for model-informed drug development - Step 5
23 days ago
ICH M15 Guideline on general principles for model-informed drug development - Step...
Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation
25 days ago
Concept paper on the revision of the guidelines on Good Manufacturing Practice...
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes
27 days ago
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant...
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk
27 days ago
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with...
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
27 days ago
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant...
Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development
about 1 month ago
Concept paper for the development of a reflection paper on the use...
Concept paper on the revision of the guideline on clinical evaluation of diagnostic agents and its appendix 1 on imaging agents
about 1 month ago
Concept paper on the revision of the guideline on clinical evaluation of...