Open AccessA REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA
Author(s) -
Vishal Prajapati,
Rahulgiri Goswami,
Pratik Makvana,
Jitendra Kumar Badjatya
Publication year - 2014
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i1.7
Subject(s) - business , drug , quality (philosophy) , process (computing) , product (mathematics) , drug control , drug approval , drug development , work (physics) , regulatory science , control (management) , clinical trial , public relations , medicine , political science , pharmacology , engineering , management , computer science , economics , mechanical engineering , philosophy , geometry , mathematics , epistemology , pathology , operating system
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.