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Major Duties and Staffing Quota

  Pursuant to the Circular on Issuance of Plan for Institutional Reform of the Shanghai Municipal People’s Government by the General Offices of both the Central Committee of the Communist Party of China and the State Council, Shanghai Food and Drug Administration (Shanghai FDA) is now an administrative body affiliated to the Shanghai Municipal Health Bureau. The administration’s major duties include:

  II. Major Duties

  (I) To implement laws, regulations, rules, guidelines, and policies on safety of food, health products, cosmetics and drugs, formulate and implement local policies and plans on safety of drugs, medical devices, food and cosmetics, and facilitate the drafting of relevant laws and regulations as well as departmental rules;

  (II) To regulate food, health products and cosmetics in line with law, formulate local standards for food safety, conduct administrative and technical supervision on the research, production, circulation and usage of drugs and medical devices in Shanghai, oversee food distribution and consumption processes (including the catering sector and dining halls) as well as the production, circulation and consumption of health products (including cosmetics) in line with the Food Hygiene Law of PRC and local regulations, and coordinate and investigate into major food safety incidents on behalf of the Municipal Government;

  (III) To oversee safety evaluation of food, health products and cosmetics, formulate and implement disclosure procedures for such safety information together with related departments, and publicize major safety information on a regular basis;

  (IV) To conduct preliminary review of applications for new and generic drugs, protected Traditional Chinese Medicine (TCM), pharma-packaging materials and health food, organize the OTC drug system, review and approve hospital preparations and their usages, issue certificate for exported drugs upon application, monitor and re-evaluate adverse reactions to drugs used in Shanghai, review and approve drug and health product advertisements;

  (V) To enforce statutory standards for medical devices, review and approve registrations of class II medical devices, monitor and re-evaluate adverse reactions to medical devices used in Shanghai, review and approve advertisements of medical devices;

  (VI) To implement quality standards and corresponding accreditation for manufacturing and distribution of drugs and medical devices as well as hospital preparations in line with law, and issue licenses to qualified entities;

  (VII) To conduct preliminary review of clinical drug research organizations, ensure compliance with quality standards for non-clinical drug research and clinical drug tests, oversee quality inspection organizations for drugs and medical devices, and accredit qualified entities for medical device quality inspection;

  (VIII) To regulate psychotropic substances, narcotic, toxic, detoxification and radioactive drugs as well as specialty devices in line with law;

  (IX) To monitor quality of drugs and medical devices, publicize quality gazettes, and investigate and punish acts of producing and/or distributing counterfeit and inferior drugs and medical devices as well as other acts in violation of relevant laws and regulations;

  (X) To oversee the registration and regulation of licensed pharmacists, and implement the pharmacist qualification system together with competent authorities;

  (XI) To facilitate Shanghai’s exchange and cooperation in regulation of drugs and medical devices and safety administration of food, health products and cosmetics with international organizations and foreign governments;

  (XII) To deal with administrative review applications and litigations;

  (XIII) And to perform other duties assigned by the Municipal Government.

  III. Divisions

  According to the aforementioned duties, the Shanghai FDA is made up of twelve divisions, namely:

  (I) General Office (also General Office of the CPC FDA Committee)

  (II) Division of Legal & International Affairs

  (III) Division of Personnel and Education

  (IV) Division of Planning and Finance

  (V) Division of Circulation

  (VI) Division of Food Safety Supervision(Division of Food Licence)

  (VII) Division of Food Safety Coordination

  (VIII) Division of Drug Registration

  (IX) Division of Drug Safety and Inspection

  (X) Division of Medical Devices Registration

  (XI) Division of Medical Devices Safety Inspection

  (XII) Division of Inspection

  A department for discipline inspection and supervision and a CPC committee are also established pursuant to relevant provisions.

  IV. Staffing Quota

  The staffing quota for Shanghai FDA is 80 positions, including one Director-General, three Deputy Directors-General, one party secretary, one deputy party secretary, 25 heads and deputy heads of divisions, and five commissioners for food safety.

  V. Miscellaneous

  (I) The current vertical management system remains unchanged.

  (II) Shanghai FDA also hosts the General Office of Shanghai Municipal Joint Conference for Food Safety.

  (III) Matters regarding the establishment, duties, and staffing quotas of public service institutions affiliated to Shanghai FDA are stipulated separately.

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