The drug administrations of provinces, autonomous regions, and municipalities directly under the Central Government, and the Ministry of Health of the General Logistics Department of the People's Liberation Army: the
　　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:
　　1. For new drugs that have obtained new drug protection before September 15, 2002, the new drug protection period remains unchanged.
　　2. For new drugs that have been approved for clinical research but not approved for production by the Bureau before September 15, 2002, they shall still be approved in accordance with the relevant provisions of the original drug registration management. After approval of production, according to the original "New Drug Approval Measures", a 5-year transition period shall be granted for Class I new drugs; a 4-year transition period shall be granted for Class II new drugs; and a 3-year transition period shall be granted for Class III to Class V new drugs. transition period. During the transition period, other drug manufacturers are not allowed to produce the same type of drug.
　　3. For new drugs that have been accepted by our bureau before September 15, 2002 but have not been approved for clinical research, and new drugs accepted by our bureau after September 15, 2002, the revised "Drug Administration Law" and "Implementation Regulations" Approval of relevant regulations. That is: for varieties that have not been marketed in China, they shall be approved in accordance with new drugs, and for new drugs produced by approved drug manufacturers, a monitoring period of no more than 5 years shall be established; for varieties that have been marketed in China, they shall be approved in accordance with existing national standards. Drug approval.