Questions and answers on the withdrawal of the CPMP Note for guidance on preclinical pharmacological and toxicological testing of vaccines

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2016
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The CPMP Note for guidance on preclinical pharmacological and toxicological testing of vaccines was adopted in 1997 (1). No revision of the guideline has taken place after that. There is a need to consider revision of the document. The WHO plays an important global role in vaccine development. As part of this effort, they have developed guidelines directed to national regulatory authorities and vaccine manufacturers. The WHO guideline on nonclinical evaluation of vaccines (2) was published in 2005 and was the result of a collaboration between experts from different regulatory agencies, health agencies, academic institutions and vaccine manufacturers. EU regulators took active part in this work. 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.