General Administration to Revise 3050 National Drug Standards


Time:

2018-01-29

Recently, the State Food and Drug Administration issued an announcement, proposing the goal of my country's food and drug standard work by 2020, requiring accelerated establishment of "the most rigorous standards", building a scientific, comprehensive, testable, and enforceable food and drug standard system, and comprehensively improving The level of food and drug supervision. The State Food and Drug Administration proposed that by 2020, a standard system that meets the needs of food and drug safety supervision, has a complete system, reasonable structure and outstanding technology will be basically established, and the scientificity, effectiveness and applicability of the standards will be significantly enhanced. The standard management mechanism is more sound, basically forming the public food and drug safety standard can be guaranteed, supervision and law enforcement.

Recently, the State Food and Drug Administration issued an announcement, proposing the goal of my country's food and drug standard work by 2020, requiring the acceleration of the establishment of "the most rigorous standards" and the construction of a scientific, comprehensive, testable, and enforceable food and drug standard system To comprehensively improve the level of food and drug supervision.

The State Food and Drug Administration proposed that by 2020, a standard system that meets the needs of food and drug safety supervision, has a complete system, reasonable structure, and outstanding technology will be basically established, and the standards will be scientific, effective, and applicable. Significantly enhanced. The standard management mechanism has become more sound, basically forming a good situation in which the safety of public diet and drug use is guaranteed, supervision and law enforcement is based on standards, market norms are based on standards, and innovation is driven by standards.

Specifically, it will strengthen the effective connection between food safety standards and supervision, promote the revision of pesticide residue limit standards, and formulate and issue veterinary drug residue limit standards. Mandatory standards have been implemented in all directions. 3050 national drug standards were formulated and revised, including 1100 national drug standards for traditional Chinese medicine, 1500 chemical drug standards, 150 biological product standards, 200 pharmaceutical auxiliary materials standards and 100 drug packaging materials standards. 500 medical device standards were formulated and revised, including 80 diagnostic reagent standards, 200 active medical device standards, 220 passive medical devices and other standards.

In response, the General Administration stated that it will accelerate the improvement of the standard level from four aspects: improve the scientific and practical nature of food standards to ensure public food safety; accelerate the upgrading of drug standards to ensure the safety and effectiveness of drugs; Improve the technological innovation capability of medical device standards and lead the development of high-tech products; improve the cosmetics standard system to promote product safety and quality.

In terms of improving the standard management mechanism, the General Administration pointed out that it will strengthen the overall management of standards, basic research on standards, the construction of standard talent teams, international exchanges and cooperation, and the implementation of standards.