Hunan Provincial Food and Drug Administration

Internal agencies

Office

Main responsibilities Responsible for the daily operation of the organs of the work of communications, meetings, confidentiality, archives and other security, confidentiality, letters and visits; undertake statistics, comprehensive information management; guide the construction of information technology in the system; responsible for the organization of emergency management of emergencies related to food and drug safety, command and coordination; assume the news release and News propaganda work.

Policy and Regulation Division

Main Duties and Responsibilities Drafting of local laws and regulations in the area of food and drug supervision and management; reviewing and approving the legality of normative documents; supervising the administrative law enforcement; undertaking administrative reconsideration, administrative appeals and hearings; and undertaking the investigation and research on major policies related to the supervision and management of food and drug.

Food Safety Inspection Division (Food Licensing Division)

Main Duties Responsible for the supervision and management of food safety in the consumer sector; supervise the implementation of food safety management standards in the consumer sector; undertake the investigation and monitoring of food safety in the consumer sector, and release information related to the supervision and management of food safety in the consumer sector; undertake the evaluation of the safety of cosmetics in accordance with the law; undertake the supervision and management of cosmetics hygiene. Supervision and management work; undertake food, cosmetic health license management; supervise the implementation of food, cosmetic health licensing of relevant norms; according to law to undertake the use of new cosmetic raw materials, domestic production of special-purpose cosmetics, such as the examination and approval work.

Pharmaceutical Registration Division

Main Duties Supervise the implementation of national pharmaceutical standards; formulate local standards for Chinese herbal medicines, Chinese medicinal materials, Chinese medicinal preparations and quality standards for preparations in medical institutions; be entrusted by the State Bureau to undertake the registration of relevant medicines, packaging materials and containers in direct contact with medicines and medicinal excipients; be responsible for the registration of preparations in medical institutions and their management; preliminary examination of clinical pharmacological bases and supervision and management of clinical trials of new medicines; supervise and manage clinical trials of new medicines; supervise and monitor the use of new raw materials and production of domestic special purpose cosmetics. Supervision and management of clinical trials of new drugs; supervise the implementation of non-clinical studies of drugs, clinical trials of drugs, quality management standards; implementation of Chinese medicine varieties of protection system; guide the province's pharmaceutical products, pharmaceutical packaging materials testing organizations in the business.

Medical Devices

Major responsibilities Supervision and implementation of medical devices, sanitary materials, products, statutory standards and medical device product classification and management directory; responsible for the issuance of two types of medical device product registration, review of registered product standards; supervision and management of medical device clinical institutions; organization and implementation of medical device quality system assessment, supervision and implementation of medical device production, quality management standards and certification; responsible for the issuance of medical device quality management standards and certification work; responsible for the issuance of medical device clinical trials. Certification; responsible for the issuance of medical devices production, business licenses and on-site inspection work, responsible for a class of medical device manufacturers for the record; responsible for the organization of medical device registration verification work; responsible for medical device adverse event monitoring and re-evaluation work; guidance for medical device testing and technical review of the agency's business.

Drug Safety Supervision Division

Major responsibilities Supervision and implementation of the production of Chinese herbal medicines, drug production and medical institutions, such as the preparation of quality management standards; the issuance of drug production, medical institutions, preparation licenses; in accordance with the administrative authority to undertake the commissioning of the production of medicines for the initial examination, approval and supervision and management; undertake the production of pharmaceuticals and health care institutions, such as the supervision of preparation and other licensing supervision; in conjunction with the implementation of the national essential drug system, the initial examination and recommendation of the national pharmaceutical industry, the implementation of the national drug safety supervision and control system. Basic drug system, the first review and recommendation of the national essential drugs list and non-prescription drug list, the first review of prescription drugs and non-prescription drugs conversion evaluation; in accordance with the law to regulate the medical toxic drugs, narcotic drugs, psychotropic drugs, radioactive drugs, drug rehabilitation drugs and drugs and drug-type chemicals of the production and use of drug-type chemicals; organization and implementation of the monitoring of adverse drug reactions, drug re-evaluation and elimination of the work.

Pharmaceutical Market Supervision Division

Main Duties Supervision and implementation of prescription drugs, non-prescription drugs, Chinese herbal medicines, Chinese medicine, the purchase and sale of slices of Chinese medicine; supervision and implementation of the quality management standard of drug business; according to the law issued by the drug business license; according to the law on the implementation of the supervision of the use of drugs in medical institutions; according to the law to supervise the operation of toxic drugs for medical use, narcotic drugs, psychotropic drugs, radiopharmaceuticals, detoxification drugs and drug-type chemicals. The operation of classifiable toxic chemicals; supervision of Chinese herbal medicine market; supervision of Internet drug information services and trading behavior; organization and implementation of prescription drugs and non-prescription drugs classification and management system; responsible for the approval and supervision of drug and medical device advertising.

Planning and Finance Division

Major Duties and Responsibilities Formulate departmental development plans and organize their implementation; undertake the preliminary examination, declaration and implementation of national investment projects; formulate financial management systems for the Bureau's organs and directly subordinate units and organize their implementation; prepare budgets and accounts for the Bureau's organs and directly subordinate units and supervise their implementation; manage the finances and assets of the Bureau's organs and directly subordinate units; undertake the day-to-day financial accounting work of the Bureau; undertake the work of the Bureau's organs and directly subordinate units; prepare budgets, accounts and supervise their implementation. Financial accounting work; bear the bureau organs and units directly under the supervision and management of administrative fees; bear the bureau organs and units directly under the internal audit work.

Personnel and Education Division

Organizational Party Committee

Supervision Office

Inspector General's Office

Retirement Management Division Responsible for the management of retirees and services of the Bureau's organs, and guiding the management of retirees and services of directly subordinate units.

Directly under the Agency

Drug Evaluation and Adverse Reaction Monitoring Center