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Scientific guidelines (human and veterinary)
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Last updated 15 days ago
Guideline on quality aspects of phage therapy medicinal products
15 days ago
Guideline on quality aspects of phage therapy medicinal products
Draft guideline on quality aspects of phage therapy medicinal products
15 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
16 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
29 days 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 1 month 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 1 month ago
Draft guideline on clinical investigation of medicinal products for the treatment of...
Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis
about 1 month ago
Draft guideline on clinical investigation of medicinal products for the treatment of...
Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)
about 1 month ago
Concept paper on new guidance on the clinical investigation of medicinal products...
Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance
about 1 month ago
Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and...
Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance
about 1 month ago
Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance
Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks
2 months ago
Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I –...