Interpretation of the effectiveness of food and drug supervision in 15 years with big data

2015 was the year of the "Twelfth Five-Year Plan," and it was also a year for the management system of foods (including health foods), medicines, medical devices, and cosmetics that comprehensively managed the transition of the system and the running of institutions.

According to Bi Jingquan, director of the State Food and Drug Administration, in the year, according to the “four most stringent” requirements, the food and drug regulatory system strengthened supervision and enforcement, paid close attention to outstanding problems, and focused on preventing risk and ensuring safety; The implementation of the "Food Safety Law" and other laws and regulations will focus on the establishment of the most stringent regulatory system; the reform of the examination, approval and approval system for pharmaceuticals and medical devices will be initiated, and efforts will be made to improve the quality of manufactured products in China; and the "hidden rules" for counterfeiting of clinical trial data will be eliminated, and efforts will be made to purify the drug R & D ecology. Environment; Innovative regulatory means and supervision methods, focusing on improving the efficiency of post-event supervision; Increasing information disclosure and publicity efforts, focusing on the implementation of the main responsibility of production and management enterprises; Vigorously promoting local implementation of “four-two responsibility” and strengthening grass-roots supervisory capabilities The construction of the "three strict and three practical" special education, focus on the implementation of the party's ethical governance and construction of the main responsibility and supervision responsibility, and achieved good results, for the "Twelfth Five-Year" food and drug safety work draws a successful conclusion.

On January 14th, the National Food and Drug Supervision and Management Conference and the Party Construction and Clean Government Construction Conference were held in Beijing. The meeting summarized the 2015 food and drug supervision work, research and deployment of key tasks of food and drug supervision and party style integrity management in 2016, a reporter from the “Medicine Economic News”. Obtain first-hand data from the conference and interpret the key tasks of the food and drug regulatory system in 2015.

Investigated more than 350,000 illegal cases

In 2015, the food and drug monitoring system properly handled hot and difficult issues such as Shanghai Fuxi’s expired meat, smuggled frozen meat, “ditch oil”, “toxic watermelon”, bean sprout supervision and enforcement, and aquatic product banned drug use. Milk flight inspection, illegal addition of health wine production, fraudulent adulteration of honey, special inspection on the use of aluminum-containing food additives, deployment of flight inspections, special inspections, and centralized remediation of key products such as Chinese herbal medicines, Chinese Herbal Medicines, Ginkgo biloba, and biochemicals . In the special rectification of Ginkgo biloba drugs, measures were suspended, suspended, sealed, and recalled for 57 production companies.

Food and drug regulatory authorities at all levels investigated and handled more than 350,000 illegal cases, imposed a fine of 1.6 billion yuan, revoked 331 licenses, recalled 143 pharmaceutical GMP certificates, dismantled 963 counterfeit dens, and transferred it to the judicial authorities to deal with 3381 cases. The earthquake struck a lawless person.

Drug standards released 1082 items

In 2015, the State Food and Drug Administration stepped up efforts to promote the implementation of the "Regulations on the Implementation of the Food Safety Law," "Drug Administration Law," and supporting regulations and regulatory documents, and issued food production and operation licenses, food recalls, market sales of edible agricultural products, and pharmaceutical operations. 11 departmental regulations, such as quality management and medical device classification rules, established legal advisors and a public service lawyer system, and formulated a series of management methods such as guidance on the standardization of grass-roots law enforcement. A total of 1082 drug standards, 130 drug packaging standards and 90 medical device standards were issued throughout the year, and efforts were made to ensure that regulations were followed and regulations were followed.

All localities combined with the actual improvement of food and drug laws and regulations, Inner Mongolia, Guangdong, Shaanxi and other provinces (autonomous regions) promulgated regulations for small food shops, small restaurants and small vendors; Hebei, Hunan, and Jilin provinces introduced food safety liability insurance pilot programs; Hubei, etc. The province comprehensively regulates the duties of administrative examination and approval and administrative punishment.

Around the "Regulations on the Supervision and Management of Medical Devices", the cancellation and decentralization of administrative examination and approval implementation, the organization carried out supervision and inspection of the entire system of administrative law enforcement, and carried out spot checks on more than 50 units in 12 provinces (autonomous regions and municipalities). A total of 9 major items and 5 items of administrative examination and approval items were cancelled, decentralized, and adjusted, and 27 items of administrative examination and approval items were retained. Since the online filing of domestic non-special-purpose cosmetics, more than 380,000 items have been filed online. Food production licenses implement "five cancellations" and "four adjustments", and food business licenses realize the "two certificates of oneness" of circulation and catering services.

At the same time, the GMP and GSP transition tasks were completed on schedule. Enterprises that have not passed GMP or GSP certification since 2016 are not allowed to engage in pharmaceutical production and operations.

Clearing the clinical trial data fraud "hidden rules"

In July 2015, the State Food and Drug Administration initiated the self-examination and verification of drug clinical trial data, and conducted inspections on the authenticity and standardization of 1622 drug clinical trial data for batch production. Twenty inspection teams were dispatched in three batches to carry out on-site inspections, 14 announcements were issued, and national conferences were held for deployment. All localities took active actions and implemented supervision responsibility. Many provinces such as Heilongjiang, Jiangsu, Zhejiang, Anhui, Fujian, Jiangxi, Shandong, Henan, Guangdong, Hainan, Sichuan, Shaanxi, Liaoning, Yunnan, and Qinghai have adopted conferences, interviews, and other methods to preach policy measures and do a good job in enterprises. Self-checking organization and data verification. Of the 1622 varieties included in the bulletin, 193 were exempted from clinical trials, and the total number of self-examination and verification required was 1,429. As of January 12, the company voluntarily withdrew 1,103, did not submit a self-examination report, refused 10 approvals, disagreed with 6 withdrawals, passed 24 verifications, passed 8 assessments, and withdrawn or failed a total of 1,151 , accounting for 80% of the total number of self-inspection checks, of which the active withdrawal of companies accounted for 77%. Of the 29 species that made the verification conclusions, 24 did not pass, and the pass rate was 83%; through 5, the pass rate was 17%. The remaining items to be checked are 273.

Improve post-event supervision efficiency

Adhere to the problem-oriented, scientific application of sampling techniques and spot checks to improve the level of risk management throughout the process. The State General Administration Bureau has arranged sampling of 168,000 batches of food, and more than 410,000 batches have been arranged by the provincial bureaus, involving nearly 200 kinds and more than 3,000 items of inspection items. A sample of more than one million households of various types of food production and business operations was spotted, and there were nearly 230,000 problem companies and more than 140,000 problems. Evaluate 127 drug varieties for evaluation, carry out follow-up sampling inspections on 68 drugs, conduct supervision and sampling on capsule products, ginkgo leaf medicines, and rabies vaccines, and publish six phases of drug sample testing results notification. Supervised the disposal of 5,136 unqualified (problem) products in real time. The organization carried out supervision and inspection on 4222 batches of 49 medical device varieties, and carried out follow-up sampling inspection on 31 batches of products of 5 varieties. According to the adverse drug reaction report and safety evaluation results, ketoconazole and pemoline have taken measures to stop production, sales, and use, and to take information control measures such as metoclopramide and modify drug product specifications. 23 medical device manufacturers, such as aseptic and implantable high-risk products, were inspected for flight operations, and seven enterprises with serious defects were suspended from production and rectification. In more than 400,000 catering service units, the "Ming kitchen bright stove" project was promoted.

Increase information disclosure and promotion efforts

The portal website has become an important window for publishing supervision information such as sampling and case punishment to the public. In 2015, the website of the State Administration of the People's Republic of China had a total of 69 million visits, and the page views reached 1.46 billion pages. Medical device registration gradually realizes online centralized acceptance. The National Food Safety Awareness Week, National Safety Month, and Food and Drugs Complaints 3.1 Topics Awareness Day campaign were successfully held. Actively clear and standardize the channels for complaints and reports. 25 provinces (autonomous regions and municipalities) opened the provincial 12331 website. The number of complaints raised by the public has increased by 33% compared with the previous year. The positive regulatory power has been greatly enhanced, and negative media hype has been greatly reduced.

Implementing the "Four-Two-Responsibility" and Strengthening the Supervision and Management Ability of Grassroots

The Food Safety Committee of the State Council held a pilot meeting on the “Two Creations” pilot project for food safety cities and agricultural product quality and safety counties in Weihai, Shandong. The pilot project for establishing food safety cities was further expanded to 30 cities in 15 provinces (autonomous regions and municipalities). The “four-two responsibility” (ie, food and drug supervision is responsible, there are posts, there are people, there are means to effectively perform supervision duties and inspection duties) into the assessment system for local food and drug safety work, puts forward the on-site tabulation of food production and operation enterprises Inspection norms, the introduction of grass-roots regulatory capacity building standards. We have increased investment protection efforts and implemented a total of 6.64 billion yuan of central government funds in the year, an increase of approximately 17% over the previous year. A total of 2.96 billion yuan of special transfer funds have been issued. Supported the construction of 163 food safety inspection agencies at the provincial and municipal levels. The number of funds and projects increased by 24% and 28% respectively over the previous year. A total of 30 county-level food safety inspection agencies have been established in 16 provinces (autonomous regions and municipalities) across the country. Opened a national food and drug regulatory information platform to realize electronic supervision of all drug product manufacturing and business processes. The implementation of state-level rotation training for the heads of supervisors at various levels of training, and the implementation of various types of training nearly 8,000 people. Grass-roots regulatory capacity has been significantly accelerated. Many provinces including Shanghai, Heilongjiang, Jilin, Shanxi, Henan, Shaanxi, Gansu, and Tianjin have put forward specific measures to guarantee grassroots “accountability, dedication, manpower, and means”. Shanghai has issued a professional team of inspectors. Guidance opinions have been made in Hebei, Guizhou, Ningxia, and other provinces. The Chongqing, Hubei, Zhejiang, Guangxi, and Fujian provinces have made active explorations in promoting the gridization of the primary regulatory system.