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Scientific guidelines (human and veterinary)
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Last updated about 9 hours ago
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2
about 10 hours ago
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2
Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
about 11 hours ago
Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
about 12 hours ago
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water
11 days ago
Concept paper on the need for revision of note for guidance on...
Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs
11 days ago
Concept paper for the development of a guideline on the methodology of...
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
12 days ago
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
12 days ago
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
Concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
12 days ago
Concept paper on the new reflection paper on the clinical investigation of...
Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)
26 days ago
Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular...
Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2
27 days ago
Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous...
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials
28 days ago
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I –...
Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations
29 days ago
Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6...