Module 9 2021

23/03/2021

Guidelines relevant for nonclinical evaluation (cont.)

1: WHO-ICH-CHMP and FDA: specific

 Guideline on Influenza Vaccines, Non-clinical and Clinical Module, CHMP 2016  Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines, CHMP 2010  Guidance for Industry: considerations for Plasmid DNA Vaccines for Infectious Disease Indications. FDA, 2007  Guidance for Industry Preclinical Assessment of Investigational Cellular and Gene Therapy Products; FDA 2013

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Guidelines relevant for nonclinical evaluation (cont.)

2: guidelines from national regulatory agencies (NR): examples

 Notice on the issue of technical guidelines for preclinical research on preventive vaccines; SFDA (April 2010)  Guideline for Non-clinical Studies of Vaccines for Preventing Infectious Diseases (PFSB/ELD 0527-1); Japan MHLW 2010

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