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Scientific guidelines (human and veterinary)
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Last updated 20 days ago
Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension
21 days ago
Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products...
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
21 days ago
Concept paper on the need for revision of the guideline on clinical...
Guideline on the plant testing strategy for veterinary medicinal products
about 1 month ago
Guideline on the plant testing strategy for veterinary medicinal products
Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients
about 1 month ago
Concept paper on the development of a reflection paper on proof-of-concept data...
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
about 2 months ago
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions...
Draft guidance on the conduct of clinical trials during public health emergencies
about 2 months 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Draft guidance on the conduct of clinical trials during public health emergencies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
about 2 months ago
Draft concept paper on the development of a reflection paper on the...
Draft guideline on quality aspects of mRNA vaccines for veterinary use
about 2 months 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)
2 months 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
2 months 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
2 months 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
2 months ago
Concept paper on the revision of the guidelines on Good Manufacturing Practice...