COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

  • Dinesh Chandra Konuri
  • Mamillapalli S.
  • A. Elphine P.
  • Brahma S.R. Desu

Abstract

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.

Keywords: Generic product, PMDA, CFDA, Regulatory requirements, Registration.

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How to Cite
Konuri, D. C., M. S., A. Elphine P., and B. S. Desu. “COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 1, Feb. 2018, pp. 75-87, doi:10.22270/ijdra.v3i1.159.