Administrative regulations refer to the general name of normative documents formulated by the State Council in accordance with the Constitution, laws and legal procedures concerning the exercise of administrative power and the performance of administrative duties. The Measures for the Administration of Drug Registration is a departmental regulation formulated by the State Administration of Market Supervision in accordance with relevant laws and regulations in order to standardize drug registration behavior and ensure drug safety, effectiveness and controllable quality, so it belongs to administrative regulations.
On June 22, 2020, 1, the Measures for the Administration of Drug Registration was promulgated by Order No.27 of the State Administration of Market Supervision signed by Xiao Yaqing, and shall come into force as of July 2020. The Measures for the Administration of Drug Registration promulgated by Order No.28 of the former US Food and Drug Administration in July 2007 10 shall be abolished at the same time.
Significance of Formulating Measures for the Administration of Drug Registration
1, protecting public health and safety
Drugs are indispensable items in people's lives, and the safety and quality of drugs are directly related to public health and life safety. Formulating the Measures for the Administration of Drug Registration can standardize the registration, approval, supervision and management of drugs, ensure the safety and quality of drugs before and after listing, and thus safeguard public health and safety.
2. Standardize the drug market order.
The drug market is a special market, and the quality and safety of drugs are directly related to public health and life safety. Formulating the Measures for the Administration of Drug Registration can standardize the drug registration behavior, require drugs to undergo strict examination and approval and inspection before listing, and ensure the quality and safety of drugs, thus standardizing the drug market order and ensuring public health and safety.
3. Promote pharmaceutical science and technology innovation.
The pharmaceutical industry is a high-tech industry, and the research and development and registration of drugs require a lot of scientific and technological investment and innovation. Formulate the Measures for the Administration of Drug Registration to encourage scientific and technological innovation of drugs and promote the development and progress of the pharmaceutical industry. The Measures stipulate the registration requirements for new drugs, improved new drugs and generic drugs, encourage enterprises to innovate in drug research and development and registration, and promote the development and progress of the pharmaceutical industry.
4. Improve the level of drug supervision and management.
The Measures for the Administration of Drug Registration is an important legal basis for drug supervision and management, which is of great significance to improving the level of drug supervision and management. Formulating the Measures for the Administration of Drug Registration can standardize the drug registration behavior, strengthen the supervision and management of drugs after listing, improve the level of drug supervision and management, and ensure the safety and quality of drugs.
The above contents refer to Baidu Encyclopedia-Measures for the Administration of Drug Registration.