Licensing Guidelines and Regulations

Enfoque por país/China | Posted 09/11/2012 post-comment0 Post your comment

First posted: 9 November 2012 

Concerning biosimilars in China, view the articles: 

Chinese guidelines for biosimilars

China releases draft biosimilars guidance

Strategy for biosimilars in China

According to the Chinese Ministry of Health, by the end of October 2010, the three public health insurance schemes covered 1,233 million Chinese citizens, accounting for more than 90% of the total population [1].

The regulatory body for approval of pharmaceutical products in China is the SFDA. The agency evaluates the safety, efficacy and quality of drugs applying for marketing approval in China and decides whether or not to approve such applications [4].

China has introduced significant regulatory changes in an effort to modernise its pharmaceutical industry and bring it in line with international standards. These include the reorganisation of the former State Drug Administration in 2003 into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing [2].

Pharmaceutical products are now patentable in China, but before the patent law was amended as of 1 January 1993, pharmaceuticals were specifically excluded from the patent system [2]. This meant that generics had a major foothold in the Chinese pharmaceutical market.

Pharmaceutical products may be placed on the market in China after approval by the SFDA, which is modelled on the US FDA. Since 1998, the government has raised the bar for entering the pharmaceutical business by passing laws including drug management law and regulations on pharmaceutical manufacturing. There should be no big differences between Chinese pharmaceutical regulations and those of the US, partly because China is following and trying to keep up with the standards of EU, Japan and US [3].

Marketing applications from domestic applicants are handled according to the procedures and requirements for new drugs or generic drugs, whereas marketing applications from overseas applicants are handled according to those for imported drugs [4].

Applications for generic drugs may refer to drugs which already have an existing national drug standard which is approved to be marketed by the SFDA, whereas applications for biological products must be submitted via a new drug application [4].

Drugs applying for importation to China need to have already obtained drug marketing authorisation in the producing country or region where the overseas pharmaceutical manufacturer is located.  Those not yet having obtained marketing authorisation in the producing country or region but with confirmed safety, efficacy and clinical data by the SFDA may be approved for importation [4].

The production of drugs must comply with the GMP requirements of both the producing country or region where the drug manufacturer is located and China [4].


1.  Datamonitor. China pharmaceutical market overview [monograph on the Internet]. Pharmaceutical Market Research [cited 2012 Aug 2]. Available from:

2.  Tsoi A. Pharmaceutical policies and regulations in China. Deacons. 2007 June.

3.  Tigermed. Overview of Chinese Regulatory Framework [monograph on the Internet] [cited 2012 Nov 9]. Available from:

4.  SFDA. Provisions for drug registration. SFDA order no. 28 [monograph on the Internet]. SFDA [cited 2012 Nov 9]. Available from:

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