State Food and Drug Administration "three fixed" plan announced
Release time:
2018-08-08
State Food and Drug Administration "three fixed" plan announced
From: China Medical Device Industry Association website
On May 15, the website of the editorial Office of the people's Republic of China announced the provisions on the establishment and staffing of the main responsibilities of the State Food and drug administration. The Regulations clarify that the State Food and Drug Administration (at the ministerial level) is an agency directly under the State Council, with 345 administrative staff, including 1 director and 4 deputy directors, and an additional deputy director concurrently serving as the deputy director of the National Health and Family Planning Commission; There are 60 leading positions in the department and 10 national food and drug inspectors.
Some functions "abolished" and "decentralized"
According to their functions, the State Food and Drug Administration has 17 agencies. The original Food Supervision Department "changed from one to three". Among them, the first and second divisions are respectively responsible for the food situation, existing problem analysis and suggestions in the production and circulation and consumption links; the third division is responsible for analyzing and predicting the overall food situation and carrying out food risk early warning.
The Pharmaceutical and Cosmetic Registration Administration Division, the Pharmaceutical and Cosmetic Supervision Division, the Medical Device Registration Administration Division and the Medical Device Supervision Division shall be established.
An emergency management department was added to be responsible for emergency response to major food and drug accidents; in order to promote the construction of the food and drug inspection and testing system and the electronic supervision and traceability system, a science and technology and standards department was added; and a news and publicity department was added.
In this institutional reform, the State Food and Drug Administration will "cancel" and "decentralize" some functions ".
The drug production administrative license and drug production quality management standard certification, drug business administrative license and drug business quality management standard certification, cosmetics production administrative license and cosmetics health administrative license are integrated into one administrative license. At the same time, the continuing education management responsibilities of licensed pharmacists will be canceled and replaced by the China Licensed Pharmacists Association.
Apply for administrative license for the certification of quality management standards for drugs and medical devices, re-registration of drugs and supplements that do not change the internal quality of drugs, apply for administrative license for changes in the internal quality of domestic third-class medical devices that do not change the internal quality of products, administrative license for entrusted production of drugs, and import of non-use The administrative license for cosmetics is delegated to the provincial food and drug regulatory department.
Food regulatory links reduced
The "Regulations" clarify that in the future, edible agricultural products will be supervised by the agricultural department from planting and breeding to entering the wholesale, retail market or production and processing enterprises, and then by the food and drug regulatory department.
According to the "Regulations", the former Ministry of Health determined the qualifications of food inspection institutions and the responsibilities of formulating inspection specifications, which will be assigned to the State Food and Drug Administration. The bureau will also integrate the food inspection and testing institutions of the General Administration of quality Supervision, Inspection and Quarantine of the people's Republic of China and the former State Food and Drug Administration to share resources.
Sun Meijun, head of the Comprehensive Department of the State Food and Drug Administration, believes that the number of food from farmland to dining table has been reduced from the previous five regulatory departments to the State Food and Drug Administration and the Ministry of Agriculture. The regulatory links have been reduced, and there are fewer gaps and blind spots in supervision. This helps to avoid the problem of unclear responsibilities and prevarication, and to achieve seamless supervision of food throughout the process.
There's less repetition and more interdependence.
After this reform, great changes have taken place in the mode of division of responsibilities among departments, with fewer repetitions and more interdependence.
After the institutional reform, the State Food and Drug Administration added the brand of the Office of the Food Commission of the State Council to perform the duties of comprehensive coordination, supervision and inspection.
The National Health and Family Planning Commission organizes inspections and risk assessments of foods that may have hidden dangers, and promptly notifies the State Food and Drug Administration. The two will jointly establish a mutual notification mechanism and a joint disposal mechanism for major adverse drug reaction events.
The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China shall collect and summarize the information on imported and exported food, and notify the State Food and Drug Administration in a timely manner.
The food and drug regulatory department shall inspect the advertisements of drugs, medical devices and health food, and notify the administrative department for industry and commerce of the information on illegal advertisements and put forward suggestions for handling them.
The Ministry of Commerce is responsible for formulating plans and policies for the development of drug circulation, as well as for promoting the development of catering services and alcohol circulation. The State Food and Drug Administration is responsible for the supervision of drug circulation, catering service food and alcoholic food. The Ministry of Commerce shall obtain the consent of the State Food and Drug Administration before issuing import licenses for pharmaceutical precursor chemicals.
The State Food and Drug Administration will establish a linkage mechanism between administrative law enforcement and criminal justice work with the Ministry of Public Security. The public security organs examine the suspected illegal acts, and the food and drug regulatory authorities provide assistance in inspection, identification and identification.
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