Module 9 2024

03/09/2024

Guidelines relevant for nonclinical evaluation (cont.)

⚫ WHO guideline on Nonclinical evaluation of vaccines; WHO TRS 927 (2005) Annex 1 ⚫ WHO “Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations”, Annex 3. 2021 ⚫ Guidelines on the Nonclinical Evaluation of Adjuvanted Vaccines; WHO Adopted 2013, TRS 987 (2014) Annex 2 ⚫ Guidance on Nonclinical Safety studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2); ICH, 2009 ⚫ ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals ⚫ ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals ⚫ ICH guideline S6 (R1) – preclinical safety evaluation of biotechnology-derived pharmaceuticals (ICH, CHMP 2011) ⚫ Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications. FDA 2006

1: WHO-ICH-CHMP and FDA: general

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Guidelines relevant for nonclinical evaluation (cont.)

⚫ 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

1: WHO-ICH-CHMP and FDA: specific

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