International Journal Of Drug Regulatory Affairs
  • Year: 2022
  • Volume: 10
  • Issue: 1

Overview oi vaccine regulations in european union and Japan

  • Author:
  • Dinesh Ingle, Raj Bhavsar, Jagruti Pawar, Atul Patil, Pankaj Nerkar*
  • Total Page Count: 9
  • Page Number: 14 to 22

R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Maharashtra425405

*Corresponding author

Online published on 15 November, 2022.

Abstract

In this article we identified the important considerations, in particular, on the preclinical assessments that would allow vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region like National procedure, Decentralized procedures, Centralized procedure, Mutual Recognition Procedure (MRP) monitored by European Medicines Agency (EMA) in Europe, Pharmaceuticals and Medical Devices Agency (PMDA) in relation with Ministry of Health, Labour and Welfare (MHLW) (determines if a proposed study meets the regulatory filing requirements in Japan), The various different types of vaccine regulations was studied with its approval, and development procedure are discussed.

Keywords

Vaccine Regulation, European Medicines Agency (EMA), Marketing authorization, Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Health, Labour and Welfare (MHLW)