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Scientific guidelines (human and veterinary)
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Last updated 2 days ago
Concept paper on the development of a reflection paper on the use of External controls for evidence generation in regulatory decision-making
2 days 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
7 days 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
14 days 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
about 1 month 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
about 1 month 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
about 1 month 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
2 months ago
Draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal...
Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension
2 months ago
Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products...
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
2 months ago
Concept paper on the need for revision of the guideline on clinical...
Guideline on the plant testing strategy for veterinary medicinal products
3 months ago
Guideline on the plant testing strategy for veterinary medicinal products
Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients
3 months ago
Concept paper on the development of a reflection paper on proof-of-concept data...
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
3 months ago
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions...