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    Home > Medical News > Latest Medical News > The State Drug Administration has issued the implementation plan for the State Council to carry out the pilot program of "license separation" reform in the pilot free trade zone

    The State Drug Administration has issued the implementation plan for the State Council to carry out the pilot program of "license separation" reform in the pilot free trade zone

    • Last Update: 2019-11-29
    • Source: Internet
    • Author: User
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    The State Drug Administration has printed and distributed the implementation plan for the full coverage pilot implementation of the reform of "separation of license and license" carried out by the State Council in the pilot Free Trade Zone, and implemented the implementation plan for the full coverage pilot implementation of the reform of "separation of license and license" carried out by the State Council in the pilot free trade zone In order to implement the requirements of the notice of the State Council on carrying out the full coverage pilot of the reform of "license separation" in the pilot free trade zone (GF [2019] No 25, hereinafter referred to as "No 25 document"), comprehensively and solidly promote the reform of "license separation" in the field of drug supervision, this plan is formulated I guiding ideology Guided by Xi Jinping's socialist ideology with Chinese characteristics in the new era, we carried out the spirit of the nineteen and nineteen sessions of the second China, third and fourth plenary session of the party in a comprehensive way, and continued to deepen the reform of the "letting go management" in accordance with the decision making arrangements of the Party Central Committee and the State Council, further clarifying the responsibilities of the government and enterprises, clearing up the matters related to the business license in the field of drug supervision, and promoting the examination and approval system reform in a classified way We will improve the simple and transparent industry access rules, further expand the business autonomy of pharmaceutical, medical equipment and cosmetics enterprises, innovate and strengthen in-process and post event supervision, optimize the business environment, stimulate market vitality and promote the high-quality development of the industry II Scope and content of the pilot Since December 1, 2019, in Shanghai, Guangdong, Tianjin, Fujian, Liaoning, Zhejiang, Henan, Hubei, Chongqing, Sichuan, Shaanxi, Hainan, Shandong, Jiangsu, Guangxi, Hebei, Yunnan, Heilongjiang and other pilot free trade zones, the reform of the business license related matters in the field of drug supervision has been carried out in accordance with the implementation of the notification commitment and the optimization of the examination and approval services, so as to promote the reform in an all-round way In China, the reform of "separation of license and license" is fully covered to form replicable and popularized system innovation achievements The pilot reform involves 28 licensing matters in the field of drug regulation (see Annex), including 3 licensing matters that are promised by notification, and 25 licensing matters that optimize approval services 3 Promote the reform of examination and approval system by classification (1) clarify the three regulatory systems of informing commitments For the three items of "examination and approval of drug Internet information service", "examination and approval of medical device Internet information service" and "license for medical institutions to use radioactive drugs (class I and class II)", the provincial drug regulatory authorities in each pilot area shall, before November 30, comply with the requirements of the license conditions and the acceptance standards for the issuance of radioactive drug use license as stipulated in the administrative measures for Internet drug information service The law accurately and completely lists the specific conditions of permit that can be quantified and operated, and does not contain the underpricing clause, clarifies the post supervision measures in the event and the consequences of breach of commitment, and makes the model text of letter of commitment (the provincial drug regulatory authorities in the pilot areas shall be responsible for it) (II) carry out the examination and approval in accordance with the mode of notification commitment After the launch of the pilot project on December 1, the provincial drug regulatory authorities in each pilot area shall carry out the approval services of "approval of drug Internet information service", "approval of medical device Internet information service" and "permission of medical institutions to use radioactive drugs (class I and class II)", and inform the enterprise of the licensing conditions, in-process and post regulatory measures at one time, As well as the consequences of breach of commitment, formulate or update the guidelines, and provide the model text of letter of commitment After the applicant makes a commitment and submits the materials as required, the provincial drug regulatory authorities in each pilot area shall make a licensing decision through formal examination If the relevant conditions meet the requirements, the license shall be granted and the qualification certificate for Internet drug information service and the license for use of radioactive drugs shall be issued on the spot If the relevant conditions do not meet the requirements, the supplementary materials shall be informed once and for all on the spot After the decision of examination and approval is made, the relevant information of the examination and approval certificate shall be disclosed to the public in a timely manner according to law, so as to facilitate public inquiry and strengthen social supervision The losses caused by the failure of the examination and approval department to inform in accordance with the provisions shall be borne by the relevant examination and approval department (the provincial drug regulatory department in the pilot area is responsible for) (3) clarify the handling procedures for the two items of decentralization of approval authority In order to facilitate enterprises to work nearby, from December 1, the examination and approval authority of "examination and approval of radioactive drug production enterprises" and "examination and approval of radioactive drug trading enterprises" shall be delegated by the State Food and Drug Administration and the State Administration of science and industry for national defense to the provincial drug regulatory department and the Provincial Department of science, technology and industry for national defense in the pilot area The provincial drug regulatory authorities in each pilot area shall, by referring to the guidelines for the approval of radioactive drug production and trading enterprises issued by the State Drug Administration and other relevant regulations, formulate and publish accurate, complete, concise and easy to understand guidelines before November 30, clarify the application procedures, improve the working standards, refine the responsibilities of departments, and do a good job in directly accepting the "approval of radioactive drug production enterprises" and All preparations for the approval of radioactive drug trading enterprises The State Food and drug administration shall, together with relevant departments, formulate and issue the requirements for examination and approval as soon as possible (the provincial drug regulatory departments in the pilot areas and the drug regulatory department of the State Food and drug administration are respectively responsible for) (IV) do a good job in the connection and implementation of the decentralization of approval authority From December 1, the provincial drug regulatory authorities in each pilot area shall, in accordance with the law, examine and approve the production and marketing enterprises of radioactive drugs, standardize the discretion, strictly restrict the time limit, eliminate the hidden threshold, and continue to strengthen personnel training After the approval decision is made, the relevant information of the approval certificate shall be disclosed to the public in a timely manner according to law, so as to facilitate public inquiry and strengthen social supervision After the approval authority is delegated, the SDA shall strengthen the personnel training and business guidance of provincial drug regulatory departments in the pilot areas, timely carry out supervision and inspection, pay close attention to the emerging new problems, and timely solve and correct them The implementation and connection of the administrative licensing matters should be done well to ensure that the licensing matters under decentralization can be opened, connected and well managed (the provincial drug regulatory authorities in the pilot areas and the drug regulatory department of the State Food and drug administration are respectively responsible for) (V) updating the guidelines for 23 matters of optimized approval services In order to improve the efficiency of examination and approval and reduce the cost of handling affairs, from December 1, we took measures to optimize the examination and approval services, such as streamlining the examination and approval materials, optimizing the process of handling affairs, and reducing the time limit of examination and approval, for 23 licensing items, such as "drug production enterprise license", "cosmetics production license", "class II and class III medical device production license" The drug regulatory authorities involved in the pilot licensing matters shall formulate and update the guidelines in a timely manner and make them public before November 30 (the acceptance and reporting center of the State Food and drug administration, the drug registration department, the drug supervision department, the provincial drug regulatory departments in the pilot areas, and the drug regulatory departments of the people's governments at the city and county levels in the pilot areas are respectively responsible for) (VI) implement the reform measures to optimize the examination and approval services The drug regulatory authorities involved in the pilot licensing shall, in accordance with the specific reform measures listed in Document No 25, simplify the licensing conditions and approval materials for "drug manufacturing enterprise licensing" and other possible matters, and resolutely cancel the "wonderful work certificate" For the "cosmetics production license" and other matters, the application and approval of the whole online processing shall be adopted to optimize the processing process For "re registration and approval of domestic drugs" and other matters, the related on-site inspection is adopted to optimize the handling process and further improve the approval efficiency The approval time limit shall be reduced for the "production license for class II and class III medical devices" and other possible matters (the drug registration department and Drug Supervision Department of the State Food and drug administration, the provincial drug regulatory departments of the pilot areas, and the drug regulatory departments of the people's governments at the city and county levels of the pilot areas are respectively responsible for) IV improve the supporting measures for reform (I) strengthen the in-process and post supervision According to the "four strictest" requirements, make full use of inspection, inspection, monitoring and other means, strengthen daily supervision and management, investigate and deal with illegal behaviors such as false promises and illegal operations according to law, and urge enterprises to continue to operate in accordance with law In the process of supervision, if any false promise or serious untrue promise is found, the enterprise shall be ordered to make rectification within a time limit If the enterprise fails to make rectification within the time limit or fails to meet the requirements after rectification, the license shall be revoked according to law, and the corresponding license application shall not be accepted within a certain time limit in accordance with relevant laws and regulations The loss caused by false promise or breach of promise shall be borne by the enterprise itself (2) innovate the supervision work mode Enterprises that have committed to obtain permits through notification shall be treated equally with enterprises that have obtained permits through general approval procedures We will promote the improvement of coordination and cooperation mechanisms among drug regulatory, national defense science and industry, ecological environment and other departments, and share relevant information in a timely manner, with regard to matters under the delegated examination and approval authority According to the requirements of credit supervision, strengthen the use of inspection results, implement joint incentive for trustworthy enterprises and joint punishment for dishonest enterprises We will further strengthen social supervision and handle complaints and reports in a timely manner in accordance with the law We should give full play to the role of industry associations and guide social forces to actively participate in the governance of market order (3) continuously improve the service level We will further promote the standardization of approval services, standardize discretion, tighten time limits, and eliminate hidden barriers We should accelerate the "Internet plus government service" and promote the business license matters related to enterprises from the application, acceptance to the whole process of audit and certification Strengthen the supervision and management of the examination and approval behavior, establish the "good and bad evaluation" system of examination and approval service, and evaluate the service performance by the enterprise (4) adhere to the principle of promoting reform in an orderly manner in accordance with the law According to the adjustment of laws and regulations, the regulations and normative documents shall be adjusted in time, and the unified and clear guidance documents for local implementation of reform shall be issued in time, so as to provide system support for the pilot project of "separation of licenses" reform In the process of promoting the pilot work, new situations and problems shall be studied and reported in a timely manner (5) to do a good job in the acceptance and approval of the transition period The provincial drug regulatory authorities in each pilot area shall accept the applications for "approval of radioactive drug production enterprises" and "approval of radioactive drug trading enterprises" in the pilot area as of December 1 The applications for "approval of radioactive drug production enterprises" and "approval of radioactive drug trading enterprises" in the pilot areas accepted by the national drug regulatory authorities before December 1 shall be continuously approved by the national drug regulatory authorities For the remaining 26 items that have been accepted and have not been approved before December 1, the drug regulatory authorities involved in the pilot licensing items shall handle according to the specific reform measures listed in document 25 5 We will earnestly implement the reform policies (1) strengthen organizational leadership Carrying out the reform of "separation of license and license" is an important measure to implement the major decisions and arrangements of the Party Central Committee and the State Council, continuously optimize the business environment, and release the entrepreneurial and innovative vitality of enterprises The drug regulatory authorities involved in the pilot licensing should attach great importance to the reform work, put it on the important agenda, strengthen organizational leadership, timely study and solve major problems in the work, and ensure the effectiveness of various work (2) pay close attention to the implementation of the work The drug regulatory authorities involved in the pilot licensing issues should work together and closely cooperate with each other to comprehensively implement the reform tasks in the spirit of nail driving, strictly follow the requirements of the State Council documents, implement the responsibilities and track the effectiveness, and ensure the implementation of various reform measures (3) strengthen publicity and interpretation "License separation" reform pilot policy has a large amount and a wide range We need to organize the publicity and interpretation of the reform pilot policy, expand the awareness of the policy, let enterprises accurately perceive the strength and temperature of the reform, and create a good atmosphere for the smooth progress of the reform pilot Adorable adorable
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