Working Specifications of Technical Evaluation Research Group of Center for Drug Evaluation (Trial)

The Technology Evaluation Research Group of the Center for Drug Evaluation (hereinafter referred to as the "Research Group") is a permanent professional academic organization centered around it, serving drug technology evaluation and discipline construction.

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Several Policies to Promote the Accelerated Development of Biological Industry

Notice of the General Office of the State Council on Printing and Distributing Several Policies to Promote the Accelerated Development of the Biological Industry

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Guiding Principles on Alteration Research of Marketed Traditional Chinese Medicines

In order to scientifically standardize and guide the research work on the modification of traditional Chinese medicines that have been marketed, and to ensure the quality of research, the National Bureau organized the formulation of the "Already Technical Guiding Principles for Research on Changes of Listed Traditional Chinese Medicines (1)” is hereby issued, please refer to it for implementation.

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Notice on the period of protection for new drugs approved for production and clinical research before the Implementation of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China

revised "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law") and the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law") Implementation Regulations) came into effect on December 1, 2001 and September 15, 2002 respectively. The "Implementation Regulations" amended the definition of new drugs, changing "new drugs refer to drugs that have not been produced in my country" to "new drugs refer to drugs that have not been marketed in China." With the changes in the definition of new drugs, the new drug registration management system will undergo major changes, and the administrative protection system for new drugs has been cancelled. In order to properly deal with the connection between the old and new laws and regulations and reduce the impact of the revision of laws and regulations on drug registration management, our bureau has drawn up the transitional measures for the protection period of new drugs that have been approved for production and clinical research before the implementation of the "Implementation Regulations", and reported to the State Council for approval , are hereby notified as follows:

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Drug Administration Law of the People's Republic of China

This Law is formulated for the purpose of strengthening drug supervision and management, ensuring the quality of drugs, ensuring the safety of drug use for human beings, and safeguarding people's health and legitimate rights and interests of drug use.

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The state of drug safety supervision in China

Drugs are special commodities used by human beings to prevent, treat, and diagnose diseases. The effective supervision of drugs is related to the drug safety of consumers and the maintenance and protection of public life and health rights. The Chinese government has always attached great importance to drug safety supervision. Over the years, with the goal of strengthening drug safety supervision and ensuring public drug safety, it has gradually established and improved the drug safety supervision system and legal system, continuously improved the drug supply system, steadily improved the level of drug quality and safety assurance, and actively maintained Public drug rights and interests, and strive to improve public health.

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