Hengyang US Food and Drug Administration

Hengyang American Food and Drug Administration, formerly known as Hengyang American Food and Drug Administration, was founded on April 26th, 2000, and implemented vertical management below the provincial level in July of 20001year. Now it is directly under the provincial food and drug administration.

Internal organs: Office, Policy and Regulation Department, Food Safety Supervision and Coordination Department, Drug Registration Safety Supervision Department, Drug Market Supervision Department, Medical Device Department, Inspection Detachment, Personnel Education Department, Finance Department, Supervision Office and Government Party Committee.

Directly affiliated institutions: Hengyang Food and Drug Inspection and Testing Center and Hengyang County, Qidong County, Changning City, leiyang city, Hengdong County, Hengshan County, Hengnan County and Nanyue District of the US Food and Drug Administration.

According to the Notice of Hengyang Municipal People's Government on Printing and Distributing the Implementation Opinions of Hengyang Municipal People's Government's Institutional Reform Plan (Hengfa [2010] No.3) and the Notice of Hengyang Municipal People's Government on the Institutional Setup of Hengyang Municipal People's Government (Hengwei [2010] No.4) (1), the administrative examination and approval items cancelled by Hengyang Municipal People's Government are cancelled.

(2) Assigning the food hygiene license, food safety supervision of Hengyang Municipal Health Bureau and the hygiene supervision and management responsibilities of health food and cosmetics in restaurants, canteens and other consumption links (hereinafter referred to as consumption links) to the US Food and Drug Administration.

(3) Assign the responsibility of comprehensively coordinating food safety and organizing the investigation and handling of major food safety accidents to Hengyang Municipal Health Bureau. (a) to supervise the implementation of policies and plans for food safety supervision and management of drugs, medical devices, cosmetics and consumption; Drafting relevant normative documents.

(two) responsible for the catering service consumption license and food safety supervision and management.

(three) to supervise the implementation of food safety management norms in consumption; Carry out investigation and monitoring of food safety in consumption.

(four) responsible for the supervision and management of cosmetics hygiene, and supervise the implementation of cosmetics hygiene standards and technical specifications.

(five) responsible for the administrative supervision and technical supervision of drugs and medical devices, and supervise the implementation of quality management norms in the development, production, circulation and use of drugs and medical devices.

(six) responsible for the supervision and management of drugs and medical devices and the registration of a class of medical devices, and supervise the implementation of national standards for drugs and medical devices; Organize and monitor adverse drug reactions and medical device adverse events; Cooperate with relevant departments to implement the national essential drug system; Organize the implementation of the national classified management system for prescription drugs and over-the-counter drugs.

(seven) to organize the implementation of Chinese medicine and ethnic medicine supervision and management norms, and supervise the implementation of Chinese herbal medicine production quality management norms and Chinese herbal medicine processing norms; Implement the protection system of traditional Chinese medicine varieties according to law.

(eight) supervision and management of the quality and safety of drugs and medical devices, supervision and management of radioactive drugs, narcotic drugs, toxic drugs and psychotropic drugs.

(nine) to investigate and deal with food safety and illegal acts in the research and development, production, circulation and use of drugs, medical devices and cosmetics.

(ten) to guide the supervision and management, emergency, inspection and information construction of food and drug related aspects in the city.

(eleven) to carry out exchanges and cooperation related to food and drug supervision and management.

(twelve) within the scope of duties, implement the national and provincial food and drug industry policies.

(thirteen) to undertake other tasks assigned by the Hengyang Municipal People's government. According to the above responsibilities, Hengyang Food and Drug Administration has internal organs 12:

(1) office.

Responsible for the daily operation, security, confidentiality, letters and visits, meetings, confidential documents, etc.; To undertake statistics, news propaganda and comprehensive information management; Guide the information construction of this system; Responsible for organizing, guiding and coordinating the emergency management of food and drug safety emergencies.

(2) Policy and Regulation Section.

Organize publicity and education on relevant laws and regulations and supervise their implementation; To undertake the legality review of normative documents; To undertake the supervision of administrative law enforcement; To undertake administrative reconsideration, administrative litigation and hearing; Organize the implementation of food and drug law enforcement inspection; Assist in handling major food and drug cases and cross-regional cases; Responsible for the issuance and replacement of law enforcement certificates of food and drug law enforcement personnel.

(3) Catering Service Supervision Division.

Responsible for the supervision and management of food safety in consumption; Supervise the implementation of food safety management norms in consumption links; To undertake the investigation and monitoring of food safety in consumption; To undertake the management of catering service license; Supervise the implementation of relevant standards for catering service licensing; Assist in emergency response, investigate and handle major food safety accidents in the consumption field.

(four) health food and cosmetics regulatory authorities.

Responsible for the supervision and management of health food; To undertake the supervision and management of cosmetics hygiene; Supervise the implementation of cosmetics safety management standards; Undertake the investigation and monitoring of cosmetic safety; To undertake the management of cosmetics hygiene license; Supervise the implementation of the relevant norms of cosmetics hygiene license; Assist in emergency handling, investigation and handling of major cosmetic safety accidents; Responsible for the monitoring of health food and cosmetics advertisements.

(5) Department of Drug Registration and Safety Supervision.

Supervise the implementation of quality management standards such as the production of Chinese herbal medicines, the production of packaging materials for drugs and direct contact drugs, and preparations of medical institutions; Entrusted by the provincial US Food and Drug Administration, it is responsible for the examination and approval of preparation dispensing and use of medical institutions within its jurisdiction; Responsible for the supervision and management of clinical trials of new drugs; Supervise the production and use of toxic drugs, narcotic drugs, psychotropic drugs, radioactive drugs, drug rehabilitation drugs and pharmaceutical precursor chemicals for medical use according to law; Implement the protection system of traditional Chinese medicine varieties according to law; Organize the implementation of adverse drug reaction monitoring; Guide the business work of the city's drug and drug packaging inspection institutions.

(6) Drug Market Supervision Section.

To supervise the implementation of the quality management standards for pharmaceutical trading; Supervise the implementation of the purchase and sale rules of prescription drugs, over-the-counter drugs, Chinese herbal medicines and Chinese herbal pieces; Organize the implementation of the classified management system for prescription drugs and over-the-counter drugs; Supervise the use of drugs in medical institutions according to law; Issuing the Pharmaceutical Business License according to law; To supervise the operation of toxic drugs, narcotic drugs, psychotropic drugs, radioactive drugs, drug rehabilitation drugs and pharmaceutical precursor chemicals for medical use according to law; Responsible for the monitoring of drug advertisements, and organize the monitoring of medical devices, health foods and cosmetics advertisements; Responsible for the supervision and management of drug information services and transactions on the Internet.

(7) Medical device supervision department.

Supervise the implementation of medical device standards and medical device product classification management catalogue; Supervise the implementation of quality management standards in the process of research and development, production, circulation and use of medical devices; Implement the medical device certification system; Organize and implement monitoring of adverse events of medical devices; Issuing licenses for the production and operation of medical devices according to law; Responsible for issuing the registration certificate of Class I medical devices; Responsible for the monitoring of medical device advertisements.

(8) Planning and Finance Department.

To formulate the development plan of the food and drug industry in the whole city; To formulate the financial management system of bureau organs and directly affiliated units and organize their implementation; Prepare the budget and final accounts of the bureau organs and directly affiliated units and supervise their implementation; Responsible for the daily financial accounting work of the bureau; Responsible for the supervision and management of the assets management and administrative fees of the bureau organs and directly affiliated units; To undertake the internal audit work of bureau organs and directly affiliated units; To undertake the examination and approval of the basic construction of bureau organs and directly affiliated units.

(9) Personnel Education Section.

Responsible for personnel, labor wages, organization management, retired cadres management, professional titles and foreign affairs management of bureau organs and directly affiliated units.

And other related work; To formulate a training plan for food and drug supervision and management personnel in the region and organize their implementation; To undertake the education and training of food, medicine and other related employees.

(10) Audit Bureau

Accepting case reports and complaints, and being responsible for investigating and handling cases of food safety violations in the fields of medical devices (including drugs, medical devices, drug packaging materials and containers), health food, cosmetics and consumption; Organize and implement the inspection and sampling plan of relevant personnel; Supervise product recall; Cooperate in handling major cases and cross-regional cases; Other matters assigned by the presidium.

(1 1) supervision office

Under the leadership of the discipline inspection and supervision department at a higher level and the party group of this bureau, carry out administrative supervision, be responsible for investigating and handling cases of violation of discipline by the staff of the bureau organs and directly affiliated units, and cooperate with the publicity and education work of building a clean and honest party style.

(12) Party committees of organs

Be responsible for the Party-mass work of the Bureau and its directly affiliated units.

Discipline inspection (supervision) institutions shall be set up in accordance with relevant regulations. The US Food and Drug Administration has 38 administrative staff, including: director 1, 3 deputy directors, discipline inspection team leader 1 and trade union chairman1; Department-level leaders 10 (including the director of the supervision office 1 person) and deputy department-level leaders 19.

The government logistics service is fully funded by four people. (1) agent

The branch offices of Yanfeng, Shigu, Zhu Hui and Zhengxiang of Hengyang Food and Drug Administration were established, and the brands of Yanfeng, Shigu, Zhu Hui and Zhengxiang Food and Drug Enforcement Brigade were added as the agencies of Hengyang Food and Drug Administration. The required personnel were transferred from Hengyang Health Supervision Institute to 15 people, including 2 people working in Yanfeng/kloc-0, 9 people working in Shigu, 2 people retiring, 9 people working in Zhu Hui, 3 people retiring in Zhengzhou 10, and 63 people are planned to be transferred, including 55 people working and retiring.

(2) Public institutions

1, Hengyang Institute for Drug Control was renamed Hengyang Food and Drug Inspection and Testing Center, and the brand of Hengyang Adverse Drug Reaction Monitoring Center was added, and a two-brand institution was implemented, which was a deputy-level institution managed by the US Food and Drug Administration in Hengyang.

2. Retain the establishment of the inspection detachment of the US Food and Drug Administration in Hengyang City and set it as a department-level institution managed by the US Food and Drug Administration in Hengyang City.

The organizational plans of the above-mentioned institutions and institutions shall be issued separately.

(3) The supervision and management of health food shall be the responsibility of Hengyang Food and Drug Administration, unless otherwise stipulated by laws and regulations.

(four) the division of responsibilities of food production, circulation and consumption supervision and management. Hengyang Municipal Health Bureau is responsible for supervising the hygienic standards and conditions for food production and circulation formulated by the state, as well as the conditions for inclusion in the food production and circulation license. Hengyang City, the United States Food and Drug Administration is responsible for the supervision and management of catering service licenses in the catering industry, canteens and other consumer areas. Hengyang Municipal Bureau of Quality and Technical Supervision is responsible for the supervision and management of food production licenses. Hengyang Administration for Industry and Commerce is responsible for the supervision and management of food circulation license. No longer issue hygiene licenses for food production and circulation.

(5) Division of responsibilities for drug circulation management. Hengyang Municipal Bureau of Commerce is the competent department of drug circulation industry, responsible for studying and formulating the development plans and policies of drug circulation industry, promoting the structural adjustment of drug circulation industry, guiding the reform of drug circulation enterprises and promoting the development of modern drug circulation methods. The US Food and Drug Administration of Hengyang City is responsible for the access management and drug circulation supervision of drug circulation enterprises according to law, drawing up relevant standards for quality and safety in the process of drug circulation and supervising their implementation; Cooperate with Hengyang Municipal Bureau of Commerce to implement the development plan and policy of drug circulation industry.