Regulatory requirements and registration process of Generic Drugs in China

  • Posted on: 31 January 2016
  • By: admin

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PharmaTutor (February- 2016)


Print-ISSN: 2394 - 6679
e-ISSN: 2347 - 7881
(Volume 4, Issue 2)


Received On: 07/09/2015; Accepted On: 11/09/2015; Published On: 01/02/2016


Jitendra Kumar Badjatya
Deputy Manager-DRA,
Montajat Pharmaceutical Company Limited, Dammam, KSA


ABSTRACT: A Generic Product must meet the standards established by China Food and Drug Administration (CFDA) to be approved for marketing in China respectively. This study covers the introduction to generic drugs, in China regulatory authorities. It also includes the requirements and registration of Generic Drugs.
Many large pharmaceutical companies have increased their presence in emerging markets in recent years like China markets is predicted to be the second largest market after US in Pharmaceuticals. China is moving past its phase as a supply market for ingredients and generic finished drugs. So, is more important to know about Regulatory considerations and Registration process of Generic Drugs. This article focuses in particular on pharmaceuticals companies, the Registration process of Generic Drugs, and their activities in the China.


How to cite this article: Badjatya JK; Regulatory requirements and registration process of Generic Drugs in China; PharmaTutor; 2016; 4(2); 13-18