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Scientific guidelines (human and veterinary)
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Last updated about 17 hours ago
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
about 17 hours 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)
about 17 hours 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
1 day 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
1 day ago
Concept paper on a paediatric update on the guideline on the development...
Draft guideline on non-inferiority and equivalence comparisons in clinical trials
1 day ago
Draft guideline on non-inferiority and equivalence comparisons in clinical trials
Guideline on quality aspects of phage therapy medicinal products
22 days ago
Guideline on quality aspects of phage therapy medicinal products
Draft guideline on quality aspects of phage therapy medicinal products
22 days 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
23 days ago
Reflection paper on non-human primates in safety testing of human medicinal products...
ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5
about 1 month ago
ICH M14 guideline on general principles on planning, designing, analysing, and reporting...
Guideline on in-use stability testing of veterinary medicinal products
about 1 month ago
Guideline on in-use stability testing of veterinary medicinal products
Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1
about 2 months ago
Draft guideline on the clinical evaluation of medicinal products intended for the...
Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1
about 2 months ago
Draft guideline on clinical investigation of medicinal products for the treatment of...