Shanghai Food and Drug Administration Deepening | 'Let's Wear' | Reform | Medical Device Approval Will Change

Medical Network September 7th, September 4th, Shanghai Food and Drug Administration issued the "Implementation Opinions on Deepening the 'Administrative Examination and Approval of Reform and Optimization of 'Legigation Service'". The reform is based on the unified national deployment, and will be GMP certified. The GSP certification of the drug is merged with the drug production license and the drug business license respectively; the second type of medical device product registration and the medical device production license change have two pre-requisites for the examination and approval, and the serialization model is processed in a sequential order. For the parallel mode that can be processed at the same time, shorten the product approval period.

Implementation Opinions of Shanghai Food and Drug Administration on Deepening the Reform and Optimization of 'Putting Service'

In order to implement the spirit of 'transforming government functions, deepening the decentralization of government, innovating supervision methods, enhancing government credibility and execution, and building a service-oriented government that is satisfactory to the people in the report of the 19th National Congress of the Communist Party of China, Premier Li Keqiang deepened his efforts in the country. The 'five for' 'six one' requirements emphasized in the reform and transformation of government functions on the video conference, and the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices", "The State Council's Further Promotion of Shanghai" Separation of the 'Recommendation of the Pilot Work Plan', "Efforts to Optimize the Business Environment and Accelerate the Construction of an Open System for the New System of Action", "Towardly Promote the Work of a Network-wide Office", Accelerate the Work Plan for the Construction of a Smart Government, and Deepen the Implementation of the Pilot Reform of the Pudong New Area The plan and other requirements, further deepen the reform of the 'distribution service' of our bureau, optimize the administrative examination and approval, and formulate this plan.

Fully implement the spirit of the 19th National Congress of the Communist Party of China, guided by Xi Jinping's new era of socialism with Chinese characteristics, and in accordance with the overall arrangements of the Party Central Committee, the State Council, the Municipal Party Committee, and the municipal government on the reform of the administrative examination and approval system, benchmarking the highest international standards, the best level, Learn the advanced experience of brother provinces and cities, adhere to problem-oriented, demand-oriented, effect-oriented, use 'five for' 'six one' as a yardstick, find short-week weaknesses, consolidate and enhance advantages, and fully utilize the rule of law and the rule of law. Comprehensively deepen the reform of the 'testimony separation' pilot and the 'distribution service' reform, comprehensively promote the 'one network management office', and further optimize the city's food and biology medicine Industrial business environment, further release of innovation Start a business Vitality, effectively protect the safety of the public diet.

We should comprehensively sort out the changes. We should comprehensively sort out all the administrative examination and approval items implemented by the SIPO, check the problems one by one, propose reform measures in a targeted manner, and strengthen the post-event supervision programs, complementing shortcomings, strengths and weaknesses.

In accordance with the law, strengthen supervision. Adhere to the framework of laws and regulations, under the premise of not reducing the examination and approval standards, scientifically and standardizedly promote various reform measures. Resolutely follow the 'four most stringent' requirements, implement the main responsibility of enterprises, strengthen supervision 4. The department's overall process supervision responsibility, adhere to the food and drug safety bottom line.

Risk management, classification promotion. Conduct risk assessment before reform, prioritize reform for low-risk approval links or products, and do a good job before and after the reform. Risky reform measures, pilot first, after the experience is mature, the city replicates and promotes Step by step, steadily advance.

System integration, multi-party linkage. Strengthening the construction of free trade zone, the construction of science and technology center, the pilot reform of 'license separation', the reform of drug and medical device review and approval system, the optimization of business environment, and the linkage of various reform tasks such as 'one network management', Propose a reform plan for system integration. Strengthen the linkage between different approval links, reduce duplication of review, avoid repeated on-site inspections, strengthen linkages between various departments, form synergies, and implement various reform measures.

Reengineering the process, improving the service. Deepening the 'Internet + government service' comprehensively, promoting the 'one network management office', focusing on the electronic examination of administrative examination and approval, and re-engineering the mode and process of administrative examination and approval power, improving the depth of online processing, and effectively improving government affairs. Service Level.

Focus on all 53 administrative examination and approval items implemented by the SIPO, item by item, propose reform measures for system integration and strengthen the post-event supervision program, cancel a batch, complete a batch on the spot, optimize the process to shorten the time limit, and do ' Can be put out, can be simple and simple, can be combined, can be as soon as possible, one network through, after the event to strengthen supervision ', and strive to achieve all approvals only run once, once completed, minimize the approval, reduce links, Subtracting materials, reducing the proof, reducing the time, reducing the number of runs, continuously improving the sense of acquisition and satisfaction of enterprises and the masses.

This program adopts 1-5 reform methods for each administrative examination and approval item, and should be reformed, including cancellation, merger, decentralization or change to 9 service items, 12 reform approval methods, 19 optimization processes, and optimization of services. 26 items, all the items to achieve a network management, shorten the actual processing time limit, strengthen the integration of the post-event supervision system. At the same time, clarify the responsibility of each reform initiative, reform the expected results, time nodes and other content, form a list of administrative approval items reform (see Attachment).

1. Merger approval. According to the national unified deployment, the drug GMP certification and drug GSP certification are combined with the drug production license and the drug business license.

2. Cancel the approval. Cancel according to law cosmetic Appraisal of sanitary conditions of production enterprises, application for protection of Chinese medicines (initial review), drug Advertising, such as off-site filing, medical device advertising review, medical institution radioactive drug use license (Class I, II), etc. At the same time, narcotic drugs, first-class psychotropic drugs and second-class psychotropic drug substance production plans and narcotic drugs, The first category of psychotropic drugs needs to be changed from approval to service.

3. Decentralized approval. The domestic non-special-purpose cosmetics filing is devolved to the District Market Supervision Bureau, and merged with the district market supervision bureau's preliminary review duties.

4. Implementation on the spot. Medical device clinical trial filing, registration of imported medicinal materials, drug import filing, overseas vaccine manufacturers proxy Institutional filing, pharmaceutical manufacturers accepting the registration of processed drugs by overseas pharmaceutical manufacturers, licensing of pharmaceutical business enterprises (excluding pharmaceutical retailers), reduction of business scope, registered address, personnel changes, etc., third-class medical device operating enterprise license (third party) In the case of personnel change in the logistics), 8 items of the license renewal in the food production license is issued (special food), and the implementation is carried out on the spot.

5. Licensing to change the case. According to the unified deployment of the national bureau, the traditional Chinese medicine preparations prepared by the traditional process in the registration of the medical institution preparations, and the commissioning of the Chinese medicine preparations in the medical institutions shall be changed from the license to the record.

6. Expand the scope of the pilot program of the notification system. First, for the simple production process, the food production license for low-risk varieties will be announced in the Pudong New Area pilot project. If the enterprise application materials are complete and promise to meet the food production conditions, the food production license can be issued first. On-site verification, shortening the time limit for accreditation. Second, on the basis of the pilot project in Pudong New Area, the food business license for low-risk business projects and the approval of the drug medical device Internet information service will be extended to the city's implementation, shortening the time limit for approval.

7. Shorten the time limit and improve efficiency. At the same time of exposing the statutory time limit, according to the actual work, self-pressurization, open commitment to the time limit, and strive to shorten the administrative approval time limit of all examination and approval matters by more than 40%.

8. Serialization and parallel connection. The second type of medical device product registration and medical device production license change have two pre-requisites for approval, and the serialization mode that is processed in sequence is reformed into a parallel mode that can be processed simultaneously. Product approval approval cycle.

9. Internal Authorization Approval. Change of registration items for approval of drug manufacturing enterprises (company name, legal representative, registered address, unified social credit code), second, third class medical device production license change, re-issuance and continuation, The continuation of the registration of the second type of medical device products, the change of registration items and the re-certification, the change of the cosmetics production license, the continuation, the review of drug advertisements, the review of health food advertisements, and the review of medical device advertisements that have not been approved. The person in charge of the room or related directly under the unit is issued, reducing internal approval links and shortening the time limit for approval.

10. On-site inspection is carried out jointly. First, according to the application of the administrative counterpart, the drug production of the first class of psychoactive drugs and the second class of psychoactive drugs are designated for production approval, and the second type of psychotropic drug preparations are approved for production. Examination and approval of pharmaceutical precursor chemicals in the category and on-site inspection and drug approval by the pharmaceutical manufacturer for the approval of the production of four special drugs such as narcotic drugs or psychotropic drugs and compound preparations containing narcotic drugs or psychotropic substances (initial trial) The on-site inspection of the production license is carried out jointly. Secondly, according to the application of the administrative counterpart, the acquisition of toxic drugs, the approval of the operation (wholesale), the approval of the operation of the poppy shell (wholesale), and the examination and approval of the pharmaceutical enterprises engaged in the wholesale business of the second category of psychotropic drugs, On-site inspection of the operation and approval of six special drugs, such as the licensing of pharmaceutical precursor chemicals, the approval of protein assimilation preparations, the wholesale approval of peptide hormones, and the approval of pharmaceutical companies for the regional wholesale business of narcotic drugs and the first class of psychotropic drugs. The on-site inspection of the drug business license is carried out jointly. Third, according to the application of the administrative counterpart, The quality management system verification and medical device production license inspection for the newly-established medical device manufacturing enterprise applying for product registration for the first time shall be jointly carried out. According to the relevant regulations of the medical device manufacturing enterprises exempted from on-site inspection, the qualified product registration quality management system shall be passed. Production companies that have verified the whole project are exempt from on-site inspection and reduce repeated on-site inspections.

11. Guide the implementation of the retail pharmacy 'one application, simultaneous processing' reform. Guide the market supervision bureaus of each district, provide the 'one application, simultaneous processing' approval method path when the enterprise applies for the drug retail license, the drug business license, the drug business quality management Standardized certification, medical device business license, food business license, second-class medical device business record and other matters implement the 'one application, simultaneous processing' approval work mechanism.

12. Strengthen the connection between the technical review link and the administrative review link. Technical reviewers and administrative reviewers strengthen information exchange, intervene in advance, seamlessly connect, avoid double review, and speed up the process.

(4) Optimizing services to promote industrial innovation and development

13. Institutional innovation, serving the national strategy. According to the “Comprehensive Deepening of the China (Shanghai) Pilot Free Trade Zone Reform and Opening Program”, we will improve the pilot system for drug listing license holders, fully implement the pilot system of medical device registrants, and further optimize resource allocation. Unleash the vitality of innovation.

14. Encourage innovation and service industry development. First, implement the General Office of the Central Committee of the Communist Party of China, the General Office of the State Council, “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation of Pharmaceutical Medical Devices”, formulate and implement the implementation opinions of this Municipality, and promote enterprises to improve innovation and R & D capabilities, speed up the marketing of new drugs and advanced medical devices. Second, the implementation of the "Shanghai second class medical device priority approval procedures", the requirements of innovative medical devices and clinically urgently needed medical devices into the priority approval process, in the acceptance Prior to providing technical services, and through the implementation of expert consultation, early intervention and guidance, tracking services throughout the process, reducing the risk and uncertainty in the market access process. Third, in the premise of insisting that the approval criteria are not reduced, advance intervention in the whole process, priority Approval of pharmaceutical production licenses and commissioned production of innovative drugs.

15. Copy and promote the 'separation of licenses' reform pilot project. On the basis of copying and promoting 10 reforms in the city, further copy and promote the import and export of non-special-purpose cosmetics in the city, and cancel the use of radioactive drugs in medical institutions (1, 2 Class) and drug advertisements in different places, drug medical device Internet information service approval notification system, drug business enterprise license (excluding drug retail enterprises), food business license, drug retail enterprise license, third type medical device business license (third party logistics) ), the third category of medical device business licenses (excluding third-party logistics) and medical institutions' radioactive drug use licenses (three or four categories), strengthen ten-entry supervision and other 10 items, and formulate relevant documents. According to the pilot situation, it will be piloted in Pudong. 'Integrity Archive' 'Risk Monitoring' 'Classification Supervision' Three methods were revised and improved and issued to the city for implementation.

16. Advance intervention, active service. Provide early consultation and guidance services for administrative counterparts, strengthen the institutionalization of advance service, standardize construction, clarify the early access to service channels, scope and content, improve the quality and success rate of enterprise applications, and improve Approval efficiency.

17. Openness and transparency, improve standardization and predictability. For the reform and optimization of administrative examination and approval matters, timely revision and disclosure of the work guide, clear commitment to deadlines, advance service channels, document templates, etc., develop and improve relevant technical guidelines, further improve the administration Standardization and predictability of approval.

(5) One Netcom Office, to achieve full online processing

18. Advance the 'One Network Management Office' in an all-round way. In accordance with the “Promoting the Construction of a Smart Government Work Plan”, all administrative examination and approval items will be gradually accepted by one network, only once, once, and gradually realize collaborative services. Office, the whole city, to build a unified data sharing exchange platform, promote data sharing, business synergy, achieve government service reduction links, reduce materials, reduce certification, reduce time, reduce running times. Relying on the 'China Shanghai' portal Website, create a unified portal and export of online government services, improve or increase online booking, public payment, logistics and other functions. In line with the city's unified electronic license library construction work, the various certificates issued by the bureau will be included in the electronic certificate library, all-round Sharing mutual recognition.

19. Process reengineering, the whole process is handled online. In accordance with the requirements of the construction work of the 'One Netcom Office', the business process reengineering of the administrative approval system for each matter is implemented, and all the examination and approval items 'full network operation' and 'one network communication office' are implemented according to the plan. The platform connects to the Shanghai legal person's one-certificate system, and establishes an online real-name identity authentication system. The enterprise passes the administrative approval comprehensive business management platform, uploads relevant electronic documents and electronic signatures; the enterprise can submit the application materials through the enterprise, and the legal person electronic Signature, process progress inquiry, electronic certificate inquiry printing and other business processing.

(6) Combination of management and management, strengthening supervision system integration

20. Strengthen the use of credit information. Inquire about the public credit report of the administrative counterpart through the online government lobby, and combine the credit information pushed by the bureau and relevant departments to implement priority approval, advance service, parallel approval, and merger for the food and drug producers. Check and inform the commitment and other series of credit incentives; For the administrative counterparts with poor credit status, in the administrative licensing or filing work, the credit review measures for the above-mentioned simplified procedures, such as the key review object, the implementation of the restriction enjoyment commitment, etc. The illegal cost of breaking the trust of the most serious offenders and the implementation of the market exit mechanism.

21. Strengthen the integration of the supervision system after the event. Only when the management can approve the 'subtraction', do the 'additional law' to strengthen the supervision, strictly implement the 'four most strict', and supervise the enterprise implementation. The main responsibility, establish and improve the post-event supervision system, comprehensively use social co-governance, credit supervision, classified supervision, 'double random, one open' and other types of supervision, strengthen the integration of regulatory measures, and build a life cycle covering food and medicine. The closed loop of supervision, in the combination of release and management, puts emphasis on both the release and the management. At the same time, strengthen the information sharing and coordination between departments, and implement joint punishment for serious and untrustworthy enterprises according to law.

(1) Unifying thinking and understanding, strengthening organizational leadership

Fully understand the urgent situation and significance of deepening the reform of the administrative examination and approval system. Under the unified arrangements of the reform leadership group, all relevant offices implement various reform measures and strengthen post-event regulatory measures. The Office of the Reform Leading Group is responsible for coordinating and supervising all Implementation of reform measures.

(II) Strengthening the construction of technical support system

For the administrative examination and approval items of various reforms and optimization, the relevant departments need to put forward the information system design requirements. The Science and Technology Department will coordinate with the information center to plan, coordinate, coordinate the construction of the administrative approval information system, and do a good job in information technology support and platform data docking. Work. All relevant directly affiliated units should cooperate with the municipal bureau to do a good job in the acceptance of administrative examination and approval, technical review, authorization and issuance, etc., strengthen technical support, and strengthen communication with the relevant departments of the municipal bureau. At the same time, the relevant departments are authorized to directly The matters issued by the unit will strengthen guidance and training, do a good job of reforming the connection, solve the problem internally, and leave the trouble to themselves, 'cutting inward', reducing the cost of doing business.