As of 21 March 2010, a SingleEU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready? Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA & other EU/EFTA authorities by world-leading CE Marking Specialists based in London/UK. Click to get FREE Guide Now!
SFDA of China
As part of the government restructuring announced in March 1998, the Ministry of Health's Department of Drug Administration merged with the State Pharmaceutical Administration of China (SPAC) to become the State Drug Administration (SDA). As a result, SDA oversees all drug manufacturing, trade, and registration.
In 2003, the SDA was restructured to become the State Food and Drug Administration (SFDA). Other former functions of the ministry have been assigned to different government bodies. The most important of these was the transfer of medical insurance responsibilities to the new Ministry of Labor and Social Security. Nonetheless, the Ministry of Health retains its other main functions-regulatory development and oversight, healthcare resource allocation, and medical research and education. The Chinese government's establishment of a single drug regulatory authority was an important step toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more transparent. SFDA now oversees all medications-both Western and TCM-as well as advertising.
SFDA's new regulations follow US FDA's model. In July 1999, as part of medical insurance reform, SFDA released its first list of over-the-counter (OTC) medications, and in 2000, the state began to regulate OTC and prescription drugs separately. SFDA did so to encourage patients to purchase OTC medicines for less serious diseases, thereby reducing government medication expenditures and hospital visits. The SFDA plans to cut the number of manufacturers down to around 2,000 over the next two years by attrition and by requiring remaining firms to meet the new GMP standards. In fact, SFDA required all pharmaceutical companies in China to obtain GMP certificates from SFDA by June 30, 2004 to be licensed to sell their drug products in China. About 3000 of the companies met the deadline; companies in the process of obtaining certification may subcontract secondary production to a certified company until June 30, 2005.
In 2005, SFDA launched a regulation on drug research and supervision management aimed at enforcing GLP to investigative drugs, traditional Chinese medicine injections and biotechnology products. The regulation aims to help China’s drug research and development gain international recognition.
Main Responsibilities of the SFDA
1. To organize relevant authorities to draft laws and regulations on the safety management of food, health food and cosmetics; organize relevant authorities to formulate comprehensive supervision policy, work plan and supervise its implementation.
2. To exercise comprehensive supervision on the safety management of food, health food and cosmetics in accordance with laws; organize and coordinate supervision work on the safety of food, health food and cosmetics carried out by relevant authorities.
3. To organize and carry out investigation and impose punishment on serious safety accidents of food, health food and cosmetics; delegated by the State Council, organize, coordinate and conduct specific law-enforcement campaigns over safety of food, health food and cosmetics nationwide; organize, coordinate and collaborate with relevant authorities in carrying out emergency rescue work on serious safety accidents of food, health food and cosmetics.
4. To comprehensively coordinate the testing and evaluation for the safety of food, health food and cosmetics; formulate provisions on releasing of supervision information for safety of food, health food and cosmetics in conjunction with relevant authorities and monitor their implementation; sum up safety information of food, health food and cosmetics from relevant authorities and release it to the public regularly.
5. To draft law and administrative regulations on drug administration and supervise their enforcement; carry out protection system for certain traditional Chinese medicinal preparations and administrative protection system for pharmaceuticals in accordance with law or regulations.
6. To draft law and regulations on administration of medical devices and supervise their enforcement; take charge of registration and regulation of medical devices; draft relevant national standards, draw up and revise professional standards of medical devices, manufacturing practice and supervise their implementation.
7. To be in charge of drug registration, draw up, revise and promulgate national standard of drugs; draw up criteria for marketing authorization of health food; review and approve health food; set up classification system for prescription drugs and OTC drugs; establish and improve ADR monitoring system; be responsible for drug reevaluation, review drugs to be withdrawn and formulate national essential medicines list.
8. To draft and revise good practices for drug research, manufacturing, distribution and use, and supervise their implementation.
9. To control the quality of drugs and medical devices in manufacturers, distributors and medical institutions; release national quality bulletin on drugs and medical devices on a regular basis; investigate and punish illegal activities of producing and selling counterfeit and inferior drugs and medical devices in accordance with law.
10. To regulate radioactive pharmaceuticals, narcotics, toxics, psycho -tropics, and other controlled drugs and devices in accordance with law.
11. To draw up and improve qualification system for licensed pharmacist, supervise and direct the registration of licensed pharmacist.
12. To direct national drug regulation and comprehensive supervision on the safety management of food, health food and cosmetics.
13. To carry out exchanges and cooperation in drug regulation, relevant safety management of food, health food and cosmetics with foreign governments and international organizations.
14. To undertake other work assigned by the State Council.
English
UK/Europe
Australia
USA/Canada
Brazil
Mexico