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Scientific guidelines (human and veterinary)
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Last updated 4 days ago
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
4 days ago
ICH M14 guideline on general principles on planning, designing, analysing, and reporting...
Guideline on in-use stability testing of veterinary medicinal products
13 days 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
14 days 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
14 days 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
14 days 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)
14 days 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
19 days 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
19 days 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
about 2 months ago
Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I –...
Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease
2 months ago
Concept paper on the need for revision of the guideline on the...
Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
3 months ago
Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Revision 2
3 months ago
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products...