Shanghai Food and Drug Administration to deepen the "tube service" reform medical device approval will be a big change

On September 4th, the Shanghai Food and Drug Administration issued the Implementation Opinions on Deepening the Reform of "Management Services" and Optimizing Administrative Approval. According to the unified deployment of the state, the reform will be drug GMP certification, drug GSP certification and drug production license and drug business license, respectively, the second category of medical device product registration and medical device production license changes 2 items of approval matters with a back-and-forth relationship, from the sequence of the series mode, reform to a simultaneous processing mode, shorten the product market approval cycle.
Shanghai Food and Drug Administration on deepening the reform of "management services" to optimize the implementation of administrative approval
In order to implement the 19th National Congress of the Communist Party of China report "to transform government functions, deepen the decentralization of government, innovation of supervision, enhance the credibility and enforcement of the government, build the people's satisfaction with the service-oriented government" spirit, Premier Li Keqiang in the national deepening of "release and service" reform and transformation of government functions teleconsced stressed the "five for" six "one" requirements, as well as "on deepening review and evaluation" Opinions on The Reform of the Approval System to Encourage Innovation in Pharmaceutical Medical Devices", "Approval of the State Council on Shanghai's Pilot Work Programme for Further Promotion of the Reform of "Separation of Licenses" "Focus on Optimizing the Business Environment to Accelerate the Construction of a New Institutional Action Plan for an Open Economy", "Comprehensively Promote the "One Network Office" and "Speed Up the Construction of a Smart Government Work Programme" and "The Pilot Deepening implementation Plan for the Reform of the Separation of Licenses" in Pudong New Area" and other requirements, and further deepen the reform and approval of the "Administration and Administration" of our Bureau.I. Overall Requirements
(I) Guiding Ideology
To fully implement the spirit of the 19th National Congress of the Party, guided by Xi Jinping's thought of socialism with Chinese characteristics in the new era, and in accordance with the overall deployment of the reform of the administrative examination and approval system by the CPC Central Committee, the State Council, as well as the municipal committees and municipal governments, to the highest international standards and best levels, to learn the advanced experience of brother provinces and cities, to adhere to the problem-oriented, demand-oriented, effect-oriented, "five for" six One "as a measure, find short board weaknesses, consolidate and enhance advantages, make full use of the rule of law thinking and rule of law approach, comprehensively deepen the "separation of certificates" reform pilot and "tube service" reform, and comprehensively promote the "one-network operation", further optimize the city's food and biopharmaceutical industry business environment, further release the vitality of innovation and entrepreneurship, effectively protect public food and drug safety.
(ii) The basic principles
be comprehensively combed and should be changed. All the administrative examination and approval matters implemented by our Bureau to conduct a comprehensive combing, one by one to check the problem, targeted reform initiatives and strengthen the after-the-fact supervision program, to make up for the board, strength and weakness.
strengthen supervision in accordance with the law. Adhere to the framework of laws and regulations, under the premise that the approval standards are not lowered, scientific and standardized to promote various reform initiatives. Resolutely in accordance with the "four most stringent" requirements, the implementation of corporate responsibility, strengthen the regulatory authorities throughout the process of regulatory responsibility, adhere to the bottom line of food and drug safety.
risk control, classification advance. Carry out risk assessment before the reform, for the low-risk approval link or product, priority reform, do a good job before and after the reform of the convergence work. Riskier reform initiatives, pilot first, experience mature after the city's replication promotion, step by step, steady progress.
system integration, multi-party linkage. We will strengthen the linkage of various reform tasks such as the construction of the FTZ, the construction of the science and technology center, the pilot reform of "separation of licenses", the reform of the examination and approval system for pharmaceutical and medical devices, the optimization of the business environment, and the "one network", and put forward a reform plan for system integration. Strengthen the linkage between different approval links, reduce duplication of review, avoid duplication of on-site inspection. Strengthen the linkage between departments, form a joint effort to implement various reform initiatives.
process re-create and improve service. We will comprehensively deepen the "Internet and Government Services" and promote the "One Network Office", focus on the electronicization of administrative examination and approval and break through, re-create the mode and process of the operation of administrative examination and approval power, improve the depth of online processing, and effectively improve the level of government affairs services.
(iii) Work objectives
focus on the implementation of our Bureau of all 53 administrative examination and approval matters item by item combing, put forward system integration reform initiatives and strengthen the after-the-fact supervision program, cancel a batch, close a batch on the spot, optimize the process to shorten the time limit of a batch, so that "can be released, can be simplified, Can be combined, can be as soon as possible, a network to do, after the event to strengthen supervision", and strive to achieve all the approval matters only run once, once to complete, to minimize the approval, reduce links, reduce materials, reduce certification, reduce time, reduce the number of running, and constantly improve the enterprise and the masses of the sense of access and satisfaction.I. Reform Initiatives
This program adopts 1-5 reform methods for each administrative examination and approval matter, so that it should be changed, including 9 items of cancellation, merger, decentralization or change to service matters, 12 items of reform and approval, 19 items of optimization process, 26 items of optimization of services, all matters to achieve a network, shorten the actual processing time frame, strengthen the integration of the after-the-fact supervision system. At the same time, the responsibility offices of the various reform initiatives, the expected effectiveness of the reform, time nodes and other content, to form a list of administrative examination and approval matters reform (see annex).
(a) decentralization of government and reduce the number of
1. Consolidated approval. According to the unified deployment of the country, the drug GMP certification, drug GSP certification and drug production license and drug business license respectively merged.
2. Cancel approval. According to law, five items, such as the examination of the sanitary conditions of cosmetics production enterprises, the application for the protection of varieties of Chinese medicine (first instance), the off-site filing of pharmaceutical advertisements, the examination of medical device advertisements, and the license for the use of radioactive drugs in medical institutions (classes I and II), etc. shall be cancelled. At the same time, the production plan for narcotic drugs, psychotic drugs in the first category and API in the second category and the plan for the use of narcotic drugs and psychotic drugs in the first category were changed from an examination and approval matter to a service item.
3. Decentralize approval. The filing of domestic non-special-purpose cosmetics shall be decentralized to the District Market Supervision Bureau and merged with the preliminary examination duties of the District Market Supervision Bureau.
(ii) reform the approval method and reduce the time limit
4. Implementation is done on the spot. Medical device clinical trial filing, imported medicinal materials registration filing, drug import filing, overseas vaccine manufacturers agency filing, pharmaceutical production enterprises to accept foreign pharmaceutical manufacturers commissioned processing drugs for the record, pharmaceutical business license (except pharmaceutical retail enterprises) in the scope of business reduction, registration address, personnel changes and other matters, the third category of medical device business license (third-party logistics) personnel change matters, food production license issued (special food) in the continuation of the 8 items.
5. License to file. According to the unified deployment of the State Bureau, the preparation of traditional Chinese medicine preparations and chinese medicine preparations in medical institutions shall be changed from licensing to filing.
6. Expand the scope of the pilot system of notification commitments. First, for the simple process, low-risk varieties of food production license in Pudong New Area pilot notification commitment system, enterprises apply for complete materials and commitment to meet the conditions of food production, food production license can be issued after on-site verification, shorten the time limit for licensing. Second, on the basis of the pilot project in Pudong New Area, the food business license for low-risk business projects and the internet information service approval and notification system for pharmaceutical medical devices will be extended to the whole city for implementation, shortening the time limit for approval.
7. Shorten time frames and improve efficiency. At the same time as the public statutory processing time limit, according to the actual work, self-pressure, public commitment to handle the time limit, and strive for all examination and approval matters of the administrative approval time limit shortened by more than 40%.
(iii) optimize the process and reduce the number of
8. Series change in tandeca. The second category of medical device product registration and medical device production license changes 2 items have a back-and-forth relationship of the approval matters, from the sequence of the series mode, reform to a concatenation mode that can be handled simultaneously, shorten the product market approval cycle.
9. Internal authorization approval. Changes in registration matters approved by start-up pharmaceutical production enterprises (enterprise name, legal representative, registered address, unified social credit code), changes, replacement certificates and continuations of the production licenses of medical devices in the second and third categories, changes and renewals in the registration of medical device products in the second category, changes and renewals in cosmetics production licenses, changes in pharmaceutical advertising, examination of health food advertisements and examination of medical device advertisements that have not yet been cancelled.
10. On-site inspections are carried out jointly. First, according to the application of the administrative relative, the fixed-point production approval of narcotic drugs, first-class psycho-drugs and second-class psycho-drug raw materials, second-class psycho-drug preparations fixed-point production approval, approval of pharmaceutical-type easy-to-drug chemicals in the first category and on-site inspection of drug production permits for the production of four special drugs, such as narcotic drugs or psycho-drugs, and on-site inspection and approval of drug production licenses commissioned by foreign pharmaceutical manufacturers. Second, according to the application of the administrative relative, the acquisition, operation (wholesale) approval of toxic drugs, poppy shell operation (wholesale) approval, drug business enterprises engaged in the second category of psychopicide wholesale business approval, drug-type easy-to-drug chemicals business license, protein assination agents, peptide hormone business wholesale approval, pharmaceutical business enterprises engaged in narcotic drugs and first class of psycho-drug regional wholesale business approval and other 6 special drug business approval on-site inspection and drug business license joint inspection. Third, according to the application of administrative relatives, the quality management system verification and medical device production license inspection of newly established medical device production enterprises applying for product registration for the first time are carried out jointly. In accordance with the relevant provisions of the city's medical device production enterprises exempt from on-site verification, qualified production enterprises that pass the full verification of the product registration quality management system are exempted from on-site verification and reduce duplication of on-site inspection.
11. To guide the implementation of retail pharmacies "one application, simultaneous processing" reform. To guide the regional market supervision bureaus to provide a "one-time application, simultaneous processing" approval path when enterprises apply for drug retail licenses, and implement a "one-time application, simultaneous processing" approval mechanism for drug business licenses, drug quality management standard certification, medical device business licenses, food business licenses, and the filing of second-class medical devices.
12. Strengthen the interface between the technical review and administrative review links. Technical reviewers and administrative examiners strengthen information exchange, intervene in advance, seamlessly connect, avoid duplication of review, and speed up the processing process.
(iv) to optimize services, promote industrial innovation and development
13. System innovation, service national strategy. According to the Reform and Opening-up Program of the China (Shanghai) Free Trade Pilot Zone, we will improve the pilot system for drug market license holders, fully implement the pilot system for medical device registrars, further optimize the allocation of resources and unleash the vitality of innovation.
14. Encourage innovation and the development of the service industry. First, implement the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices, formulate and implement the Opinions of the Municipal Implementation, promote enterprises to improve their innovation and research and development capabilities, and speed up the listing of new drugs and advanced medical devices. Second, the implementation of the Shanghai Second Class Medical Device Priority Approval Procedure, the requirements of innovative medical devices and clinically urgently needed medical devices into the priority approval process, before acceptance to provide technical services, and through the implementation of expert advice, early intervention guidance, full tracking services, reduce the market access process risks and uncertainties. Third, under the premise that the approval standards are not lowered, we should intervene in advance to guide the whole process, giving priority to the approval of the production license and commissioned production of innovative drugs, etc.
15. Reproduction and promotion of the "separation of certificates" reform pilot matters. On the basis of the 10 reform items that have been copied and promoted throughout the city, further copy and promote the record management of imported non-special-purpose cosmetics in the whole city according to law, cancel the application of radioactive drug use licenses (class I and II) and drug advertisements in medical institutions for off-site filing, inform the commitment system of Internet information service approval for pharmaceutical medical devices, license for pharmaceutical business enterprises (except for pharmaceutical retail enterprises), food business license, drug retail enterprise license, category III Medical device business license (third-party logistics), third-class medical device business license (except third-party logistics) and medical institutions radioactive drug use license (three, four categories) to strengthen access supervision and other 10 matters, the formulation of relevant documents, according to the pilot situation, is being piloted in Pudong "integrity file" "risk monitoring" "classification supervision" three methods revised and issued to the city implementation.
16. Early intervention, proactive service. To provide advance consultation and guidance services for administrative relatives, strengthen the institutionalization and standardization of advance services, clarify the way, scope and content of early intervention services, improve the quality and success rate of enterprise applications, improve the efficiency of approval.
17. Openness and transparency to improve standardization and predictability. For the administrative examination and approval matters of reform optimization, revise and make public the guidelines in a timely manner, make clear the commitment to handle the time limit, advance service channels, document templates and other content, formulate and improve the relevant technical guidelines, and further improve the standardization and predictability of administrative examination and approval.
(v) a network to do, to achieve the whole process of online
18. comprehensive promotion of "one network to do." In accordance with the "comprehensive promotion of "one network to do" to speed up the construction of intelligent government work programme, all administrative approval matters gradually to achieve a network acceptance, only run once, once to do, and gradually achieve coordinated services, a network to do, the city to do, to build a unified data sharing and exchange platform, promote data sharing, business synergy, to achieve government services to reduce links, reduce materials, reduce certification, reduce time, reduce the number of running. Relying on the "Shanghai, China" portal, to create a unified entrance and export of online government services, improve or increase online booking, public payment, logistics and distribution functions. With the city's unified electronic license library construction work, will be issued by my bureau of various types of documents into the electronic license library, all-round sharing of mutual recognition.
19. Process re-creation, the entire online processing. In accordance with the "one network to do" construction work docking requirements, the implementation of administrative examination and approval system business process re-creation of various matters, according to the plan to achieve all the approval items "full network office", "one network to do." Bureau of administrative examination and approval platform docking Shanghai legal person one certificate system, the establishment of online real-name identity authentication system, enterprises through the administrative examination and approval of integrated business management platform, upload the relevant declaration data scanning and the implementation of electronic seals, enterprises through the enterprise side can file the declaration data, legal person electronic signature, processing progress query, electronic license query printing and other business processing.
(vi) the combination of management, strengthen the integration of regulatory
20. Strengthen the use of credit information. Through the online government hall to query the public credit reports of administrative relatives, combined with our bureau and related departments pushed credit information, trustworthy food