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Scientific guidelines (human and veterinary)
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Last updated about 18 hours ago
All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 5
about 18 hours ago
All languages - Annex to the European Commission guideline on ‘Excipients in...
Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU
1 day ago
Explanatory note on the withdrawal of the interim guidance on enhanced safety...
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease
5 days ago
Concept paper on the need for revision of the guideline on clinical...
Procedural advice for vaccine platform technology master file (vPTMF) certification
8 days ago
Procedural advice for vaccine platform technology master file (vPTMF) certification
Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species
22 days ago
Concept paper for the development of a guideline on the assessment of...
Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)
22 days ago
Questions and answers on classification of a product as intended for a...
Concept paper on a paediatric update of the guideline on clinical investigation of medicinal products for the management of Crohn’s disease
23 days ago
Concept paper on a paediatric update of the guideline on clinical investigation...
Concept paper on a paediatric update on the guideline on the development of new medicinal products for the treatment of Ulcerative Colitis
23 days ago
Concept paper on a paediatric update on the guideline on the development...
Draft guideline on non-inferiority and equivalence comparisons in clinical trials
23 days ago
Draft guideline on non-inferiority and equivalence comparisons in clinical trials
Guideline on quality aspects of phage therapy medicinal products
about 1 month ago
Guideline on quality aspects of phage therapy medicinal products
Draft guideline on quality aspects of phage therapy medicinal products
about 1 month ago
Draft guideline on quality aspects of phage therapy medicinal products
Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation
about 1 month ago
Reflection paper on non-human primates in safety testing of human medicinal products...