Functions of Zhejiang Food and Drug Supervision Bureau

Zhejiang Food and Drug Administration (ZFDA) is responsible for the administrative and technical supervision over the research, manufacture, distribution and application of the drugs used in Zhejiang Province (including raw traditional Chinese medicinal materials, traditional medicines prepared in ready-to-use forms and other prepared Chinese medicines, medicinal chemicals and their preparations, antibiotics, biochemical medicines, biological products, diagnostic aids, radiopharmaceuticals, narcotics,  toxic drugs, psychotropic drugs, pharmaceutic adjuvant, medical  instruments, sanitation material and medical packing material), and the inspection and coordination of the management of food, health products and cosmetics. ZFDA undertakes the investigation on serious medical accidents in accordance with laws and regulations and is responsible for the licensing of health products.

The major functions of ZFDA are as follows:

1. Implement state laws, rules and regulations on food, health products and cosmetics. Work out local laws and regulations on safety management of food, health products and cosmetics when entrusted. Formulate and implement supervision policies and working schemes.

2. Be responsible for the supervision over the safety management of food, health products and cosmetics according to the law. Organize and coordinate the safety management of food, health products and cosmetics undertaken by relevant departments.

3. Conduct investigation on serious safety accidents of food, health products and cosmetics in accordance with laws and regulations. Authorized by the provincial government or entrusted by State Food and Drug Administration, make legal supervision over the safety of food, health products and cosmetics. Coordinate and assist relevant departments to conduct rescue work of serious safety accidents of food, health products and cosmetics.

4. Coordinate the safety testing and assessment of food, health products and cosmetics. Instruct and coordinate the establishment of food safety supervision and assessment system. Work with relevant departments to formulate ways of how to analyze, predict and issue safety information of food, health products and cosmetics and supervise the implementation. Issue the information on a regular basis.

5. Implement market access standard of health products and be responsible for business and manufacturing licensing. Supervise and implement quality rules on health products and conduct examination of their advertisements. Supervise sampling inspection of the health products and issue the quality report.

6. Supervise the implementation of state laws, rules and regulations on drugs and medical instruments. Work out local laws and regulations on the supervision and administration of herbal medicine and medical instruments when entrusted. Formulate the standardized document and implement them.

7. Supervise the implementation of legal standard of drugs. Make preliminary evaluation and recommendation of national basic medicine and OTC drug catalogues. Make preliminary evaluation of new drugs, existing national standard drugs, eliminated drugs, protected varieties of traditional Chinese medicine and bases for clinical test and pharmacology. Examine the processing procedures for traditional medicines prepared in ready-to-use forms and the varieties of preparations from medical institutions. Be responsible for the licensing of medical packing materials. Examine exported drugs. Implement drug classification and administrative protection systems.

8. Supervise the implementation of the legal standards for medical biology materials and medical instruments , and products classification management catalogue. Approve the clinic trial of medical instruments. Issue registration certificate, manufacturing and business licenses after being approved. Inspect and supervise the implementation of standard for registered products. Conduct quality system for medical instruments and supervise the implementation of quality rules. Make market supervision over the medical instruments.

9. Supervise the implementation of management regulations for drugs of non-clinic research and clinic trial, and quality regulations and certificate system for drug production, management and preparations of medical institutions. Issue drug manufacturing and business licenses and the permit for preparations of medical institutions.

10. Inspect the quality of drugs and medical instruments from the drug manufacturers and medical institutions and issue the quality report regularly. Supervise the purchase and sale rules on prescription drugs, OTC drugs, raw traditional Chinese medicinal materials and traditional medicines prepared in ready-to-use forms. Investigate and punish the illegal act and the person who is responsible concerning the making and sale of fake or bad quality medicine or medical instruments. Inspect the trading of traditional Chinese medicinal materials in city and township markets.

11. Supervise the application of narcotics, psychotropic drugs, toxic drugs, drug-relief medicine, radiopharmaceuticals and special medical instruments. Be responsible for the testing and reassessment for adverse reaction of these drugs. Approve and inspect the advertisements for drugs and medical instruments.

12. Implement qualification system and organize the qualification examination, registration and administration for licensed pharmacists. Conduct training for relevant personnel. Organize technical position assessment of medical professionals and conduct vocational qualifications admittance system.

13. Be in charge of local food and drug administrative and technical institutions in Zhejiang Province.

14. Work with macro-control departments to implement state industrial policy of food and drugs. Organize drug supervision and administration and the foreign exchange and cooperation in food, health products and cosmetics.

15. Undertake other issues assigned by the Provincial Government. Undertake routine work of Zhejiang Food Safety Commission.

TEL£º96311

ADDR£ºNo.27 Wenbei Lane, Moganshan Road, Hangzhou, Zhejiang

POST£º310012

E-MAIL£ºzdaxx@hotmail.com