Veterinary medicine developers are responsible for ensuring that they and any parties working for them comply with standards set out in European Union (EU) legislation and guidelines for good clinical practice (GCP), good laboratory practice (GLP) and good manufacturing practice (GMP) for investigational medicinal products.
The European Medicines Agency is responsible for harmonising these standards at EU level. It also coordinates inspections to verify that medicine developers comply with them.
The regulatory information on compliance for veterinary medicines is contained together with the information on human medicines, with the exception of compliance with veterinary good clinical practice and the VICH GL on good manufacturing practice for active pharmaceutical ingredients included in veterinary medicinal products:
- Good laboratory practice (GLP)
- Good manufacturing practice (GMP)
- VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products
Veterinary good clinical practice
Veterinary good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting clinical trials.
For clinical trials of veterinary products, the EU has adopted the VICH GL9: Good clinical practices - Step 7 which provides guidance on the design and conduct of all clinical studies of veterinary medicines in the target species.
The guideline is directed at all individuals and organisations involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in target species. It is intended to make sure that these studies are conducted and documented in accordance with the principles of GCP.
The Committee for Veterinary Medicinal Products (CVMP) adopted the guideline in July 2000. It came into effect in July 2001.
The Annex to Directive 2001/82/EC, as amended, sets out conditions for the conduct of clinical trials included in marketing authorisation applications.
Further information: