Notice of the State Drug Administration on Printing and Distributing the "Implementation Plan for the State Drug Administration to Implement the State Council's Deepening the Reform of "Separation of Licenses and Licenses" to Further Stimulate the Development Vitality of Market Entities"

All provinces, autonomous regions, and municipalities directly under the Central Government, Drug Supervision and Administration Bureau, Xinjiang Production and Construction Corps Drug Supervision and Administration Bureau, various departments and bureaus, and directly affiliated units:

The State Drug Administration’s Implementation Plan for the Implementation of the State Council’s Deepening the Reform of "Separation of Licenses and Licenses" to Further Stimulate the Development of Market Entities" is hereby issued to you.

State Food and Drug Administration

August 20, 2021

The State Drug Administration implements the deepening of the State Council

The reform of "separation of licenses and licenses" further stimulates market players

Implementation plan for development vitality

In order to implement the "Notice of the State Council on Deepening the Reform of "Separation of Licenses and Licenses" and Further Stimulate the Development of Market Entities" (Guo Fa [2021] No.

1.

Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, fully implement the spirit of the 19th National Congress of the Communist Party of China and the 2nd, 3rd, 4th, and 5th Plenary Sessions of the 19th National Congress of the Communist Party of China, continue to deepen the reform of “decentralization, management, and service”, and coordinate the advancement of the administrative examination and approval system Reform and reform of the commercial system, promote the reduction of licenses and simplify approvals in the field of drug supervision on a larger scale, innovate and strengthen supervision during and after the event, further optimize the business environment, stimulate the development of market players, and accelerate the construction of a domestic cycle as the main body , A new development pattern of mutual promotion of domestic and international double cycles

2.

Starting from July 1, 2021, the management of a full-coverage list of business licensing matters in the drug regulatory field will be implemented nationwide, and it will be implemented in four ways: direct cancellation of approval, approval to record, implementation of notification commitments, and optimization of approval services.

3.

In accordance with the requirements of the "Notice", a total of 27 enterprise-related business licensing matters in the field of drug supervision are included in the "Central-level Enterprise-related Business Licensing Reform List (2021 National Edition)", 1 item of approval is directly cancelled, and 3 notification commitments are implemented.

4.

In accordance with the requirements of the "Notice", a total of 6 enterprise-related business licensing matters in the field of drug supervision are included in the "Central-level Enterprise-related Business Licensing Reform List (2021 Free Trade Pilot Zone Version)", and added within the scope of the free trade pilot zone.

5.

After the implementation of the reform on July 1, 2021, the drug regulatory authorities involved in the relevant licenses shall no longer implement the approval management for the “direct cancellation of approval” and “approval to record” matters, and the approval procedure shall be terminated in accordance with the law if the application has been accepted

6.

Drug regulatory authorities at all levels shall, in accordance with the "four strictest" requirements, make full use of inspection, inspection, and monitoring methods to strengthen the entire process and life cycle of drug supervision, investigate and deal with false promises, illegal operations and other violations in accordance with the law, and urge enterprises to continue Operate in compliance with laws and regulations

7.

In accordance with the requirements of the "Notice" and the provisions of the "National Integrated Online Government Service Platform Electronic License Management Measures (Trial)", the National Bureau takes the lead in organizing the standardization of drug regulatory electronic licenses in accordance with the principle of "emergency first", and revises and improves relevant rules and regulations for the application of electronic licenses And to promote the "cross-department, cross-level, cross-regional" implementation and application of electronic licenses of drug regulatory departments at all levels

Attachment 1 Issues concerning the reform of enterprise-related business licenses by the drug regulatory authority (2021 national version).
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Attachment 2 Issues concerning the reform of enterprise-related business licenses by the drug regulatory authority (2021 Free Trade Pilot Zone Edition).
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Attachment 3 Summary Table of the Reform of Enterprise Operation Licensing Issues of the Drug Regulatory Department (2021 National Edition).
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Attachment 4 Summary Table of the Reform of Business Licensing Issues Related to Enterprises by the Drug Regulatory Authority (2021 Free Trade Pilot Zone Edition).
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