Efficacy: pharmaceuticals
The European Medicines Agency's scientific guidelines on the efficacy of pharmaceuticals help medicine developers prepare marketing authorisation applications for veterinary medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline
- Conduct of pharmacokinetic studies in target animal species - Scientific guideline
- Demonstration of palatability of veterinary medicinal products - Scientific guideline
- Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline
- Questions and answers on requirements for pre-clinical studies submitted in support of a marketing authorisation application for a veterinary medicinal product - Scientific guideline
- Statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) - Scientific guideline
Reflection papers
Questions and answers
Guidelines
- Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Scientific guideline
- Conduct of efficacy studies for non-steroidal anti-inflammatory drugs (NSAIDs) - Scientific guideline
- Demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish - Scientific guideline
- Dossier requirements for anticancer medicinal products for dogs and cats - Scientific guideline
- Performance enhancers - Scientific guideline
- Veterinary medicinal products controlling Varroa destructor parasitosis in bees - Scientific guideline
- Veterinary medicinal products for fluid therapy in case of diarrhoea - Scientific guideline
- Veterinary medicinal products for zootechnical purposes - Scientific guideline
Guidelines
- VICH GL7 Efficacy of anthelmintics: general requirements - Scientific guideline
- VICH GL12 Efficacy of anthelmintics: specific recommendations for bovines - Scientific guideline
- VICH GL13 Efficacy of anthelmintics: specific requirements for ovines - Scientific guideline
- VICH GL14 Efficacy of anthelmintics: specific requirements for caprines - Scientific guideline
- VICH GL15 Efficacy of anthelmintics: specific recommendations for equines - Scientific guideline
- VICH GL16 Efficacy of anthelmintics: specific requirements for porcines - Scientific guideline
- VICH GL19 Efficacy of anthelmintics: specific recommendations for canines - Scientific guideline
- VICH GL20 Efficacy of anthelmintics: specific recommendations for felines - Scientific guideline
- VICH GL21 Efficacy of anthelmintics: specific recommendations for chickens - Scientific guideline
Reflection papers
Guidelines
- Data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats - Scientific guideline
- Demonstration of efficacy of ectoparasiticides - Scientific guideline
- Reflection paper on resistance in ectoparasites - Scientific guideline
- Specific efficacy requirements for ectoparasiticides in cattle - Scientific guideline
- Specific efficacy requirements for ectoparasiticides in sheep - Scientific guideline
- Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats - Scientific guideline