Open AccessA New Drug Approval Process in Europe: A Review
Author(s) -
Krishnasis Chakraborty
Publication year - 2019
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v7i3.332
Subject(s) - marketing authorization , regulatory affairs , authorization , regulatory agency , agency (philosophy) , regulatory science , business , process (computing) , drug approval , drug , political science , risk analysis (engineering) , process management , public administration , medicine , pharmacology , computer science , computer security , bioinformatics , operating system , philosophy , epistemology , pathology , biology
Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and Regulatory requirements according to European Medical Agency (EMA) (1).