State Food and Drug Administration (SFDA)
| Director: | Shao Mingli |
| Vice Directors: | Liu Yi Hui Lusheng (Ms.) Zhang Jingli Wu Zhen |
| Address: | Jia 38 Beilishilu, Xicheng District, Beijing 100810 |
| Telephone: | 86-10-6831-3344 |
| Website: | www.sda.gov.cn |
| Departments: | General Office; Policy and Regulation; Food Safety Coordination; Food Safety Supervision; Drug Registration; Medical Devices; Drug Safety Administration; Drug Market Supervision; Personnel and Education; International Cooperation; CCP Committee; Discipline Inspection Group and Supervision Bureau |
SFDA is responsible for the implementation and enforcement of pharmaceutical rules and laws covering biological materials, products, and legal standards. Approval, imports, manufacturing permits, and distribution of drugs and medical-related products and materials are also the SFDA's responsibility.
SFDA is also charged with the registration, testing, and administration of pharmaceuticals, over-the-counter drugs, traditional Chinese medicines, and medical devices. In addition, SFDA determines guidelines for the use of medical devices in China.
SFDA also manages the pharmaceutical industry, and reserves the right to intervene directly in pharmaceutical enterprises, regulating pharmaceutical production equipment, packaging, and pricing. The Drug Management Bureau (DMB), formerly under Ministry of Health but now under SFDA, sets standards and drafts drug regulations. DMB is responsible for implementing the PRC's Pharmaceutical Law, examining and approving new medicines, and establishing national quality standards for drug products.
Technically, SFDA and the Price Bureau under NDRC control the pricing of pharmaceuticals. But hospital pharmacies, administered by MOH, serve as the distribution channel for roughly 85 percent of Chinese medicines. Other organizations involved in managing China's pharmaceuticals sector include the State Pharmaceutical Control Management Bureau (under the State Council) and the State Bureau for the Management of Traditional Chinese Medicine. SAIC regulates the limited retail sale of over-the-counter drugs.
Return to PART VI: State Council Directly Administered Offices