Preclinical pharmacological and toxicological testing of vaccines - Scientific guideline

Following discussion within the CHMP Safety Working Party and Vaccine Working Party, it has been agreed to remove the CPMP guideline on preclinical pharmacological and toxicological testing of vaccines, and to refer to the WHO guideline on nonclinical evaluation of vaccines.The aim of this Q&A document is to provide clarification on the grounds for this decision and the consequences thereof.

Keywords: preclinical, vaccines, non-clinical requirements, WHO, pharmacology, toxicology

Current effective version

Questions and answers on the withdrawal of the CPMP Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465)

Reference Number: EMA/CHMP/SWP/242917/2016

Initial guideline - Withdrawn

Note for guidance on preclinical pharmacological and toxicological testing of vaccines

AdoptedReference Number: CPMP/SWP/465/95Legal effective date: 01/06/1998