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Shanghai Municipal Food and Drug Supervision Administration
06.07.2010
Address: 298 Henan Rd S. ( Office hour: 9am to 5:30pm, Monday to Friday)

Telephone: 63356600 sendsend



    Shanghai Municipal Food and Drug Supervision Administration is established as an administrative institution managed by Shanghai Municipal Health Bureau in accordance with the “Notice of the General Office of the CPC Central Committee and the General Office of the State Council on Printing and Distributing ‘Plan on Reform of Organs of Shanghai Municipal People’s Government’” (Ting Zi [2008] No. 17).

    Main Functions

    1. to implement the laws, rules, regulations, guidelines and policies related to the safety control of food, health-care food and cosmetics and medicine supervision and administration; to formulate local policies and plans for safety supervision and management of medicines, medical apparatus and instruments, foods and cosmetics and supervise the implementation of these policies and plans; to participate in the drafting of relevant laws and regulations and departmental rules;

    2. to perform the responsibilities in the municipal food safety control and sanitary supervision and administration of health-care foods and cosmetics according to law; to organize to work out local standards for food safety; to perform the administrative supervision and technical supervision of the research and production, manufacturing, circulation and utilization of medicines and medical apparatus and instruments of the municipality according to law; to take charge of the control of the circulation and consumption links of foods (including catering and canteens, etc.) and the production, processing, circulation and consumption links of health-care foods (including cosmetics); to resume the responsibilities of comprehensive coordination of food safety and organization of settlement of significant accidents in food safety as authorized by the municipal government and the municipal health bureau;

    3. to take charge of the safety evaluation of foods, health-care foods and cosmetics; to cooperate with relevant departments to formulate the methods of publicity of information related to safety control of foods, health-care foods and cosmetics and supervise the implementation of these measures, to synthesize the key safety information from relevant departments related to foods, health-care foods and cosmetics and publicize these information in a regular manner;

    4. to take charge of the preliminary review of new medicines, generic drug products, protective species of traditional Chinese medicine, medical packaging materials and health-care foods; to organize to implement the system for nonprescription medicines; to review and approve the formulation and utilization of the preparations from medical institutions; to take charge of the issuance of export medicine certification according to application; to take charge of the monitoring and reevaluation of adverse reactions to medicines used in the municipality; to review and approve the advertisements of health-care foods and medicines;

    5. to supervise the implementation of the legal standards of medical apparatus and instruments; to review and approve the registration of Class II medical apparatus and instruments; to take charge of the monitoring and reevaluation of adverse reactions to medical apparatus and instruments used in the municipality; to review and approve the advertisements of medical apparatus and instruments;

    6. to supervise the implementation of the quality management codes and certification system of production and operation of medicines and medical apparatus and instruments and production of preparations by medical units, organize the certification of quality management standards of the medicine production and operation enterprises according to law; to issue permits for the medicine and medical apparatus and instruments production and operation enterprises and preparation by medical units;

    7. to take charge of the preliminary review of clinic research bases; to supervise the implementation of the codes for management of non-clinical studies and clinical studies of medicines; to take charge of the administration of the medicine and medical apparatus and instrument quality inspection institutions; to perform qualification for the medial apparatus and instrument quality inspection institutions and implement the relevant regulations related to the measure authentication;

    8. to control the narcotic drugs, psychotropic substances, toxic drugs, pharmaceuticals for drug addiction treatment, radioactive pharmaceuticals and special apparatus and instruments according to law;

    9. to supervise and inspect the quality of medicines and medical apparatus and instruments; to publicize quality report of medicines and medical apparatus and instruments; to investigate and punish the making and selling of counterfeit or substandard drugs, medical apparatus and instruments and any behaviors that breach the relevant laws and regulations;

    10. to take charge of the registration of licensed pharmacists, cooperate with relevant departments to organize the implementation, supervision and administration of licensed pharmacist qualification system;

    11. to carry out exchanges and cooperation between governments and international organizations in the supervision and administration of medicines and medical apparatus and instruments, and safety administration of foods, health-care foods and cosmetics;

    12. to take charge of the acceptance and hearing of relevant administrative reviews and responses to administrative proceedings;

    13. to undertake other tasks assigned by the municipal government.