Department of Regulatory affairs, Sree Siddaganga College of Pharmacy, 1st left cross,3rd block, Mahalakshmi nagara, Near railway gate, 80 feet road Batwadi, Tumkuru-572103, Karnataka-India.
Review Article
World Journal of Advanced Research and Reviews, 2023, 20(01), 404-409
Article DOI: 10.30574/wjarr.2023.20.1.2056
Received on 28 August 2023; revised on 06 October 2023; accepted on 09 October 2023
Developing a new drug requires great quantity of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the liability of evaluate whether the research data support the safety, efficacy 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 history, regulatory policy and organization, and related issues with respect to different countries like, India and Singapore.
Development; Drug; Generic; Global; Regulatory Authority
Preview Article PDF
Ashok Kumar P, Renu GM, Suhas S Gowda, Tejaswini HU, Vinay Kumar and Yashwanth HN. Current regulatory requirements and regulation on submission of ANDA in India comparison with Singapore. World Journal of Advanced Research and Reviews, 2023, 20(1), 404-409. Article DOI: https://doi.org/10.30574/wjarr.2023.20.1.2056