Preclinical pharmacological and toxicological testing of vaccines

PDF iconQuestions and answers on the withdrawal of the CPMP note for guidance on preclinical pharmacological and toxicological testing of vaccines

Reference numberEMA/CHMP/SWP/242917/2016
Published22/07/2016
Keywordspreclinical, vaccines, non-clinical requirements, WHO, pharmacology, toxicology
DescriptionFollowing 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.


Document history

Initial guideline

Withdrawn

PDF iconAdopted guideline Published: 17/12/1997


Related content


How useful was this page?

Add your rating