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Scientific guidelines (human and veterinary)
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Last updated about 1 month ago
Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases
about 1 month ago
Concept paper on the development of a reflection paper on the non-clinical...
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1
about 1 month ago
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems...
Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with WOAH recommendations - Revision 1
about 1 month ago
Guideline on data requirements for changes to the strain composition of authorised...
Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products
about 1 month ago
Concept paper on the quality and safety aspects of RNA interference and...
Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)
about 1 month ago
Concept paper on the revision of the guideline on pharmaceutical fixed combination...
Guideline on data requirements to support in-use stability claims for veterinary vaccines - Revision 1
about 1 month ago
Guideline on data requirements to support in-use stability claims for veterinary vaccines...
Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1
about 1 month ago
Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04...
Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products
about 2 months ago
Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal...
Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum
about 2 months ago
Concept paper on the revision of the guidelines on Good Manufacturing Practice...
Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths
about 2 months ago
Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance...
Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children
2 months ago
Guideline on the clinical evaluation of medicinal products for weight management -...
Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin
2 months ago
Concept paper on the revision of the guideline on data requirements for...