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Scientific guidelines (human and veterinary)
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Last updated 3 days ago
Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children
10 days ago
Guideline on the clinical evaluation of medicinal products for weight management -...
Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin
9 days ago
Concept paper on the revision of the guideline on data requirements for...
Concept paper on the revision of the guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021)
9 days ago
Concept paper on the revision of the guideline on data requirements for...
Concept paper on the revision of the guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease
6 days ago
Concept paper on the revision of the guideline on the clinical evaluation...
Concept paper on the development of a reflection paper on the use of External controls for evidence generation in regulatory decision-making
about 1 month ago
Concept paper on the development of a reflection paper on the use...
Concept paper on the need for revision of the guideline on the development of medicinal products for the treatment of smoking
about 1 month ago
Concept paper on the need for revision of the guideline on the...
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
about 1 month ago
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update...
Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2
2 months ago
Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006)...
Draft concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products
2 months ago
Draft concept paper on the development for guidance on demonstration of biosimilarity...
Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union: development of resistance and impact on public and animal health - Revision 1
2 months ago
Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS)...
Draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ - Revision 2
3 months ago
Draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal...
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
3 months ago
Concept paper on the need for revision of the guideline on clinical...