1. Requirements for GLP and GCP in the EU
5th VICH Outreach Forum meeting, February 2015, Washington DC
Presented by Dr Kornelia Grein
Head of Veterinary Medicines Department; EU Coordinator at VICH

2. EU requirements regarding GCP
“Clinical field trials shall be conducted in accordance with established principles of good clinical practice, unless otherwise justified”.
Studies must be conducted in compliance with animal welfare legislation.
Problem: Study submitted in support of a dossier considered unethical according to EU animal welfare legislation. Could e.g. occur if a study has been conducted outside EU where other animal welfare legislation. Difficult situation for the assessors when a study is unethical but scientifically sound - if refused, this means that new studies would need to be carried out.
GCP and GLP requirements in the EU

3. EU requirements regarding GLP
General principles: Pharmacological, toxicological, residue and safety tests shall be carried out in conformity with the provisions related to Good Laboratory Practice (GLP).
Pivotal studies must be according to GLP requirements, supporting studies may be not GLP.
GCP and GLP requirements in the EU

4. Thank you for your attention
Any questions
GCP and GLP requirements in the EU