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.

General

Guidelines

• Conduct of bioequivalence studies for veterinary medicinal products
• Conduct of pharmacokinetic studies in target animal species
• Demonstration of palatability of veterinary medicinal products
• Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches
• 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 veterinary clinical trials

Reflection papers

• Criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6

Questions and answers

• Questions and answers on requirements for pre-clinical studies submitted in support of a marketing authorisation application for a veterinary medicinal product - Scientific guideline

Target animal safety

Guidelines

• VICH GL9 Good clinical practices
• VICH GL43 Target animal safety: pharmaceuticals
• VICH GL52 Bioequivalence: blood level bioequivalence study

Specific guidelines

Guidelines

• Conduct of efficacy studies for non-steroidal anti-inflammatory drugs (NSAIDs)
• Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances
• 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
• Owner assessment
• Performance enhancers
• Veterinary medicinal products controlling Varroa destructor parasitosis in bees
• Veterinary medicinal products for fluid therapy in case of diarrhoea
• Veterinary medicinal products for zootechnical purposes

 

Antimicrobials

Guidelines

• Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Scientific guideline
• Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

Products for intramammary use

Guidelines

• Conduct of efficacy studies for intramammary products for use in cattle
• Local tolerance of intramammary preparations in cows

Antiparasitics (general)

Guidelines

• Summary of product characteristics for anthelmintics

 

Anthelmintics

Guidelines

• VICH GL7 Efficacy of anthelmintics: general requirements
• VICH GL12 Efficacy of anthelmintics: specific recommendations for bovines
• VICH GL13 Efficacy of anthelmintics: specific requirements for ovines
• VICH GL14 Efficacy of anthelmintics: specific requirements for caprine
• VICH GL15 Efficacy of anthelmintics: specific recommendations for equines
• VICH GL16 Efficacy of anthelmintics: specific requirements for porcines
• VICH GL19 Efficacy of anthelmintics: specific recommendations for canines
• VICH GL20 Efficacy of anthelmintics: specific recommendations for felines
• VICH GL21 Efficacy of anthelmintics: specific recommendations for poultry

Reflection papers

• Anthelmintic resistance

Ectoparasiticides

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
• Reflection paper on resistance in ectoparasites
• Specific efficacy requirements for ectoparasiticides in cattle
• Specific efficacy requirements for ectoparasiticides in sheep
• 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