Janki Patel, Nilesh Prajapati and Mansi Paradkar* Pages 4 - 12 ( 9 )
In the ASEAN countries, accessibility of generic medication is a vital issue and regulatory requirements vary from others. Hence, it is a challenging task for the pharmaceutical companies to develop a single document which can be concurrently submitted in various countries for approval. There are 10 ASEAN countries with different regulatory authority for the approval process of a drug. Though all the countries are harmonized, still every country differs in some local requirements such as administrative, quality, clinical and non-clinical documents. In the present scenario, countries like Cambodia, Laos, Vietnam and Myanmar are looking for importation of generic drugs. The purpose of this study was to provide a comparative overview on generic drug product regulation and to facilitate proper knowledge regarding critical issues, differences and similarities of drug regulation in ASEAN countries. There is a similar outline for all counties but varies from their regulatory aspects such as the need of letter of authorization, site master file, patient information leaflet, bioequivalence and clinical requirement. The present paper focuses on the specific regulatory process of Myanmar as it exhibits the high import rate as compared to other countries and it has some countryspecific guideline for market authorization.
ASEAN, generic drug, regulatory process, ANDAs, USFDA, Myanmar.
Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa, Gujarat-388421, Krosyl Pharmaceutical Pvt. Ltd., Ellora Park, Hari Nagar, Vadodara, Gujarat 390023, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa, Gujarat-388421