China

Policy

China is the only country in the world where Western medicine and the traditional medicine work alongside each other at every level of the healthcare system. Traditional Chinese medicine has its own department at the Ministry of Public Health and at provincial and county Bureaus of Public Health. It has its own medical schools, hospitals, and research institutes. Traditional Chinese Medicine is undergoing medical reform in medicine in the important role of Chinese medicine into the implementation of preferential policies, the implementation of the basic drug system, reform of public hospitals, medical insurance system was established and the price formation mechanism, give full consideration to the rules and characteristics of their own medicine in order to benefit the public as a whole.

China further developed the newest Provision for Drug Registration on 10 July 2007 in accordance with Drug Administration Law, Administrative Permission Law and Regulations for Implementation of the Drug Administration Law to ensure the efficacy, safety and quality of drugs and regulate the drug registration. Article 21 in Chapter II describes that the study in the source of the crude drugs, and of their pre-treatment and processing should be included in the pre-clinical drug study for the traditional Chinese medicine preparation.

Contact

State Food and Drug Administration (SFDA)
A38 Beilishilu 
Beijing, 100810 China
Tel.: (86-10)6831-3344
Fax: (86-10)6831-5648
Website: http://www.sda.gov.cn

Ministry of Health of the People's Republic of China, 
South Road, Xicheng District, Beijing 
No. 1 Xi Zhi Men Wai Zip: 100044 
Tel :010 -68,792,114 
Website: http://www.moh.gov.cn
State Administration of Traditional Chinese Medicine of the People's Republic of China
Dongcheng District, Beijing Workers Stadium Road 
Tel: 59957666
Website: http://www.satcm.gov.cn/web2010/
 

Laws & Regulations

Health food in China is defined as any food that has special health-related functions that are any other than nutritional in nature. This "health food" category includes all dietary supplements, functional foods, and nutraceuticals. Therefore, dietary supplements (including vitamins), functional foods and nutraceuticals are all classified as health food.  The industry is regulated by the State Food and Drug Administration (SFDA).

Products may carry unsubstantiated claims such as immune system support or weight management as long as there is a specific product disclaimer printed on the package that identifies that the product is not a traditional or western medical product.

Botanical products must be manufactured by certified and registered facilities approved by the drug regulatory authorities.  China has guidelines for Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices.  There are efforts underway to develop and implement a Good Agricultural Practices agenda.

An extensive post-marketing surveillance program has been in effect since the mid 1980's.

Marketing and sale TM/CAM products are regulated via the Drug Administration Law of 1985 which requires registration and approval of both use of TM's in studies and sale of TM through the healthcare community.

Three keys drugs laws and regulations in China:

  1. Drug Administration Law of the People’s Republic of China (Dec. 01, 2001)
  2. Regulations for Implementation of Drug Administration Law of the People’s Republic of China (Sept. 15, 2002)
  3. Regulations on Administrative Protection for Pharmaceuticals (Jan. 31, 1993)

Drug Standards Improvement Action (2006-2010) was issued to improve the standards over 4000 TCM specification approved by SFDA as well as to establish and revise the national standards of 1000 Chinese crude drugs. 

In order to promote the safe and effective use of traditional medicine, the ‘Beijing Declaration’ was approved on 8 November 2008 by the member of World Health Organization Congress on Traditional Medicine.  The declaration encourages the governments to make and improve national policies on traditional medicine. Besides that, the importance of traditional medicine in the development of public health was recognized and its integration was supported into national health systems where appropriate. It also promotes improved education, research and clinical inquiry into traditional medicine, as well as improved communication between health care providers.

Contact

State Food and Drug Administration (SFDA)
A38 Beilishilu 
Beijing, 100810 China
Tel.: (86-10)6831-3344
Fax: (86-10)6831-5648
Internet: http://www.sda.gov.cn
 

Standards & Guidelines

According to the Drug Administration Law of the People's Republic of China, the national drug regulatory department has formulated 29 provisions, including Provisions for Drug Recall, Provisions for Drug Registration, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Provisions for the Drug Distribution Licenses, and Good Supply Practice (GSP).

State Food and Drug Administration (SFDA) has carried out numerous unannounced inspections over GMP company stating 2007 to strengthen the standards and guidelines.

China practices a certification system for the quality control by promoting Good Laboratory Practice (GLP) certification for non-clinical drug research, Promoting Good Clinical Practice (GCP) certification for drug clinical trials.

There are 7,014 national standards for TCM. Among them, the 2005 Pharmacopoeia of the People's Republic of China records 582 kinds of Chinese crude drugs, prepared slices of Chinese crude drugs, fats and extracts, as well as 564 kinds of TCM preparations. Standards made by the ministry and bureaus recorded 438 Chinese crude drugs and prepared slices of Chinese crude drugs, 4,690 TCM preparations, 308 crude folk drugs and 432 folk drug preparations. To ensure the safety and efficacy of TCM injections, and establish effective quality control methods, the state is enhancing the standardization of TCM injections. 

In 2000, the state launched the" Improvement of Quality Standards of TCM Injections with the Production Permission and Work on Fingerprints Chromatogram", and issued the Technological Requirements of Fingerprint Chromatogram Research of TCM Injections. At present, China is working hard to improve the safety and quality control and indices of 123 kinds of TCM injections sold on the market, fix the production areas of crude drugs of TCM injections, strictly control the quality of raw materials, intermediate products and finished products, and realize overall quality control for production and processing.

Contact

The Chinese Central Government's Office Web Portal 
Address: -
Tel: (8610) 88050813
Fax: (8610) 63070900
website: http://english.gov.cn/index.htm

State Food and Drug Administration (SFDA)
A38 Beilishilu 
Beijing, 100810 China
Tel.: (86-10)6831-3344
Fax: (86-10)6831-5648
website: http://www.sda.gov.cn