Open AccessCOMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA
Author(s) -
Dinesh Chandra Konuri,
S. Mamillapalli,
A. Elphine P.,
Brahma S.R. Desu
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v3i1.159
Subject(s) - china , business , regulatory agency , agency (philosophy) , food and drug administration , product (mathematics) , regulatory authority , process (computing) , pharmaceutical industry , industrial organization , international trade , marketing , pharmacology , public administration , risk analysis (engineering) , medicine , political science , computer science , law , operating system , philosophy , geometry , mathematics , epistemology
A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA.
JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.