Module 9 2024

03/09/2024

European (EMA) Vaccine guidance Under "scientific guidelines"/"Multidisciplinary: vaccines". Link: https://www.ema.europa.eu/en/human regulatory-overview/research-development/scientific-guidelines/multidisciplinary guidelines/multidisciplinary-vaccines

The Organisation for Professionals in Regulatory Affairs

63

EMA Vaccines Guidances …..what to look for

⚫ Adjuvants in vaccines for human use

⚫ Clinical evaluation of new vaccines (effective 1 August 2023) (incl. Vx definition)

⚫ Draft addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals

⚫ A series of guidelines on influenza vaccines

⚫ Pharmaceutical and biological aspects of combined vaccines

⚫ Product information for vaccines

⚫ Preclinical pharmacological and toxicological testing of vaccines (note: now deleted and there is reference to the WHO guideline on nonclinical evaluation of vaccines)

⚫ Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

⚫ Also on Pharmacovigilance of Vaccines: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/12/ WC500157839.pdf

The Organisation for Professionals in Regulatory Affairs

64

32