Overview of Vaccine Regulations in European Union and Japan

  • Dinesh Ingle
  • Raj Bhavsar
  • Jagruti Pawar
  • Atul Patil
  • Pankaj Nerkar RCPIPER, Shirpur
DOI https://doi.org/10.22270/ijdra.v10i1.505

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)

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1.
Ingle D, Bhavsar R, Pawar J, Patil A, Nerkar P. Overview of Vaccine Regulations in European Union and Japan. Int J Drug Reg Affairs [Internet]. 2022Mar.15 [cited 2025Mar.18];10(1):14-2. Available from: https://www.ijdra.com/index.php/journal/article/view/505
Issue
Vol 10 No 1 (2022): VOLUME 10, ISSUE 1, 2022
Section
Review
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