Food and drug administration issues 2017 annual report on Government Information Disclosure

Source: CFDA 2018-03-20 prepares this annual report in accordance with the regulations of the people's Republic of China on the disclosure of government information The contents of the report include the general situation, the active disclosure of government information, the disclosure and non disclosure of government information according to the application, the information disclosure charges and exemptions, the application for administrative reconsideration or the filing of administrative litigation due to the information disclosure, the main problems in the information disclosure work and the improvement measures, etc The statistical period of data in this report is from January 1, 2017 to December 31, 2017 If you have any questions about this report, please contact the general office of the State Food and Drug Administration (address: No.2 office building, No.26, West Xuanwumen street, Beijing; postcode: 100053; Tel: 010-88331193) I overview In 2017, the State Food and Drug Administration conscientiously implemented the nineteen spirits of the party Guided by Xi Jinping's socialist ideology with Chinese characteristics, he paid great attention to the work of government information disclosure According to the regulations of the People's Republic of China government information disclosure, the notice of the general office of the national people's Congress on Issuing the key points of the work of making government affairs public in 2017 (China's government issued [2017] 24 No.) requirements: adhere to the general tone of seeking progress in stability, adhere to the concept of sunshine supervision, further strengthen the system construction, improve the active disclosure catalog, highlight the information disclosure in key areas, actively do a good job in policy interpretation and public opinion guidance, respond to social concerns in a timely manner, strengthen the governance of food and drug rumors, continue to increase the intensity of information disclosure, and improve the transparency of supervision 2 Actively disclose government information (1) strengthen the construction of information disclosure system Relevant system documents such as the implementation opinions of the food and Drug Administration on comprehensively promoting the publicity of food and drug administration, the administrative measures for the publicity of food and drug safety supervision information, the detailed rules for the implementation of the publicity of food and drug administrative penalty case information, etc shall be formulated and promulgated to clarify the ideas and requirements of the publicity of food and drug supervision information, establish and improve the system specifications, and the administrative department shall Regulatory information such as penalty cases shall be disclosed and detailed requirements shall be put forward For major decision-making and deployment, important policy measures and formulation and revision of laws and regulations related to public interest and high social concern, such as drug review and approval system reform, the opinions of relevant departments, relevant units and industry associations shall be widely listened to according to the procedures, and opinions shall be solicited from the public before the policy is issued, so as to expand public participation; the newly issued regulations and normative documents shall be well prepared in time Policy interpretation and positive response to social concerns (II) give full play to the role of "the first platform" for website information disclosure, and further strengthen the initiative of disclosure In 2017, the website of the general administration actively disclosed 9041 pieces of government information Among them: 1759 dynamic information, accounting for 19.4%; 4734 announcement information, accounting for 52.4%; 706 popular science information, accounting for 7.8%; 199 regulatory document information, accounting for 2.2%; 1508 column and comprehensive management information, accounting for 16.7%; 55 personnel information, accounting for 0.6%; 80 consultation information, accounting for 0.9% The website has established more than 120 information publishing columns, 4 interactive columns, 60 basic databases, 1 English website and 1 administrative licensing service sub station In 2017, the total number of independent users of the website reached 125 million, and the total number of visits to the website reached 1428 million In the "2017 performance evaluation report of Chinese government websites" of Tsinghua University, the website of the General Administration ranked sixth on the websites of ministries and commissions （3） We will strengthen information disclosure in key areas First, the information of food sampling inspection is open We will continue to optimize the frequency of random inspection information release, enrich the content of information release, and form a coordinated release cycle of weekly and monthly specific product information release, quarterly, semi annual and annual summary of random inspection, which covers the overall situation, non-conforming product situation, preliminary situation of audit and disposal, as well as inspection items and basis In 2017, the website of the State Administration of food safety released 53 issues of food safety supervision sampling information, involving 25211 batches of 30 food categories Reprinted 2199 issues of spot check information issued by Provincial Bureau A total of 26000 sampling information issues were released at the national, provincial, municipal and county levels throughout the year, involving 2.3 million batches of products We have constantly innovated the way of releasing sampling inspection information and promoted the use of "food safety inspection" mobile phone client (APP) As of December 31, 2017, the number of APP installations reached 155000, the number of views reached 9.738 million, and the average number of daily visits was 21000 We have collected 873000 pieces of food information sampled by the state, province, city and county since 2015, greatly enhancing the public's access to information and the acquisition of sampling inspection results Sense Second, food production license and regulatory information disclosure Monthly summary and statistics of the relevant data of food production license around the country, and make it public on the website of the general administration In 2017, 146626 licensed enterprises' food production license information was released Further strengthen the publicity of food production supervision information, and publicize the information of food production system inspection and flight inspection on the website of the general administration In 2017, 26 inspection letters of food safety production system were published, involving 26 enterprises; 94 flight inspection warning letters of food production enterprises were published, involving 117 enterprises Third, the registration information of special food is open Relying on the website of the General Administration, the registration information of special food was released in a timely manner As of December 31, 2017, the registration catalogue information of formula of 952 infant formula milk powder products in 34 batches and the registration catalogue information of 3 special medical formula milk powder products in 1 batch were released in the column of "key news of the General Administration" on the website of the general administration At the same time, the health food and infant and child were disclosed in the column of "enterprise query" on the website of the general administration The registration information of infant formula milk powder product formula and formula food for special medical use is convenient for enterprises and the public to inquire Fourth, the information of drug and medical device review and approval is open In order to facilitate the administrative counterpart to know the review and approval progress of medical devices in time, the administrative counterpart is provided with the review and approval progress query of the declared products by relying on the website of the drug review center and the medical device registration management information system Release the announcement of approval and registration of medical devices on a monthly basis Continuously improve the approval database information, and the registration and approval information of drugs, cosmetics and medical devices approved by the General Administration will be disclosed on the website of the General Administration for public inquiry In accordance with the relevant provisions of the standardization administrative department of the State Council, the publication, modification and repeal of 105 medical device industry standards shall be well done Organize the supervision and spot check of 20 registration application projects in 2 batches of medical device clinical trials, refuse to register 4 registration application projects with authenticity and other problems, timely release the announcement, disclose the inspection results of supervision and spot check to the public, protect the public's right to know, effectively crack down on clinical trial fraud, punish dishonest enterprises and protect public rights and interests Fifth, the information of supervision and inspection of drugs and cosmetics and sampling inspection is open Around the origin of APIs and other organizations to carry out the flight inspection of drug manufacturers, severely investigate and punish illegal behaviors, issued 9 notices in the column of "flight inspection" on the website of the General Administration, and publicized the illegal behaviors of 30 enterprises; carried out the centralized rectification of drug quality of pharmacies and clinics in rural areas, carried out flight inspection on 12 retail pharmacies in three provinces, and found violations Violations of laws and regulations shall be publicly exposed in the form of notices In 2016, we consolidated the results of special rectification in the field of drug circulation, continued to carry out flight inspection of drug wholesale enterprises, inspected 55 drug wholesale enterprises throughout the year, and notified 18 enterprises that seriously violated the GSP Four batches of flight inspections were carried out for cosmetics enterprises, including 28 production enterprises and 2 business enterprises, and the flight inspection report was made public on the website of the General Administration in a timely manner Build a unified platform for drug sampling information release, launch the drug sampling information query database on the website of the General Administration of drugs, and actively do a good job in the disclosure of drug sampling information In 2017, 46 issues of national drug sampling notice were issued, 1107 batches of substandard drugs and information of relevant enterprises and units were published; 230 issues of provincial drug sampling notice (notice) were issued Increase the intensity of cosmetic supervision and sampling information publicity, publish the 13 phase of cosmetics supervision and inspection notice throughout the year, expose 183 batches of substandard sunscreen products and 23 batches of substandard mask products, and make sure that a number of exposed products are exposed We strengthened the monitoring, analysis and evaluation of adverse drug reactions In 2017, we issued a total of 3 adverse drug reaction notifications and 12 pharmacovigilance alerts, and revised the instructions of 15 varieties to effectively control drug safety risks Sixth, the information of supervision and inspection of medical devices and sampling inspection is open The flight inspection was organized for 76 domestic medical device manufacturers and 31 medical device business enterprises, and the inspection situation was publicized in time on the website of the general administration 20 production enterprises and 4 business enterprises with serious defects were all publicized on the website of the General Administration in the form of the notice of the General Administration Organize on-site inspection of overseas medical device manufacturers, and the inspection results of 24 overseas enterprises shall be disclosed on the website of the General Administration; for two enterprises with serious defects and suspension of import, the inspection results shall be announced on the website of the General Administration in the form of announcement of the general administration Conscientiously do a good job in the supervision and sampling inspection of medical devices, a total of 29 national medical device quality announcements were issued throughout the year In 2017, 62 recall information were published in the column of "medical device recall" on the website of the General Administration, including 8 level-I recalls (only one of which is implemented overseas), and 54 level-II and level-III recalls of medical devices There are 693 recall information links published by the provincial bureaus on the website of the general administration A total of 755 recall information are publicized on the website of the general administration to effectively eliminate the potential safety hazards of medical devices and ensure the safety of medical devices The seventh is the publicity of administrative penalty information Steadily promote the information disclosure of food and drug administrative penalty cases In 2017, 249000 food and drug administrative penalty cases were publicized nationwide, an increase of 106.9% over 2016 Eighth, timely release the "power list" of the Department According to the requirements of the review and Reform Office of the State Council, the cancelled and decentralized administrative examination and approval items shall be made public on the website of the State Administration in a timely manner, and the regulatory measures for strengthening the cancellation and decentralization of administrative examination and approval items shall also be made public in a timely manner In 2017, a special column of "licensing services" was set up on the website of the General Administration, which announced 21 items of administrative approval matters of the General Administration, 41 items of administrative approval matters designated by the central government, and 6 items of intermediary services retained as necessary conditions for the administrative approval of the general administration The ninth is to do a good job in the budget and final accounts of departments and the publicity of "three public" funds According to the unified requirements of the Ministry of finance, carefully prepare the 2017 departmental budget and 2016 departmental final accounts In April 2017, on the website of the State Administration, the department budget statement and situation statement of 2017 approved by the Ministry of Finance and the State Administration were disclosed, as well as the budget situation of the "three public" funds in 2017, the operation funds of the organs, the government procurement situation, the occupancy and use of state-owned assets, the performance target setting and other information In July 2017, on the website of the General Administration, the 2016 Department final accounts statement and situation statement approved by the Ministry of finance of the people's Republic of China and the general administration were disclosed, as well as information on the 2016 "three public" expenditure, expenditure on the operation of the organs, expenditure on government procurement, possession of state-owned assets, budget performance management, etc In the public 2016 annual Department final accounts, the results of self-assessment of project performance are disclosed for the first time (4) steadily promote the publicity of the reply to the proposal of the two sessions everything