Open AccessOverview of Vaccine Regulations in European Union and Japan
Author(s) -
Dinesh Ingle,
Raj Bhavsar,
Jagruti Pawar,
Atul Patil,
Pankaj Nerkar
Publication year - 2022
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v10i1.505
Subject(s) - agency (philosophy) , regulatory agency , marketing authorization , christian ministry , european union , authorization , mutual recognition , regulatory science , welfare , business , directive , relation (database) , public administration , political science , medicine , international trade , computer science , law , computer security , data mining , bioinformatics , philosophy , epistemology , pathology , biology , programming language
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.