The new version of Drug Administration Law shall come into force as of December 1

The drug administration law of the people's Republic of China (hereinafter referred to as the drug administration law) has been revised and adopted by the 12th meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019, and shall come into force on December 1, 2019 The State Food and drug administration is speeding up the preparation and revision of supporting regulations, normative documents and technical guidelines, and will release them in succession according to the procedures We hereby announce the implementation of the newly revised Drug Administration Law as follows: 1 The newly revised Drug Administration Law on the drug listing license holder system fully implements the drug listing license holder system Since December 1, 2019, any enterprise or drug development institution holding drug registration certificate (drug approval number, imported drug registration certificate, medical product registration certificate) as the holder of drug listing license shall strictly perform the obligations of drug listing license holder and control the safety, effectiveness and quality of drugs in the whole process of drug development, production, operation and use according to law Sexual responsibility 2、 As for the record management of clinical trial institutions, since December 1, 2019, the drug clinical trial institutions shall implement the record management Before December 1, 2019, we have accepted the application for qualification recognition of clinical trial institutions that have not yet completed the examination and approval, and will not continue the examination and approval, and will file it in accordance with the regulations 3、 As for the management requirements of GMP and GSP, from December 1, 2019, GMP and GSP certification will be cancelled, GMP and GSP certification applications will not be accepted, and GMP and GSP certificates will not be issued The certification application accepted before December 1, 2019 shall be handled in accordance with the relevant provisions of the original GMP and GSP certification If the on-site inspection is completed and meets the requirements before December 1, 2019, the GMP and GSP certificates shall be issued Where the current laws and regulations require the on-site inspection, the on-site inspection shall be continued after December 1, 2019, and the on-site inspection results shall be notified to the enterprise; if the inspection does not meet the requirements, it shall be dealt with according to the regulations 4、 As for the review and approval of chemical APIs, from December 1, 2019, no drug registration certificate will be issued for the chemical APIs, which will be registered on the original auxiliary package Registration Platform by the chemical API manufacturer and reviewed and approved together 5、 For the investigation and punishment of drug illegal acts, if the illegal acts of drug development, production, trade and use occurred before December 1, 2019, the drug administration law before the revision shall apply, but if the newly revised Drug Administration Law does not consider the illegal acts or the punishment is relatively light, the newly revised Drug Administration Law shall apply If the illegal act occurs after December 1, the newly revised Drug Administration Law shall apply Drug regulatory authorities at all levels should resolutely implement the "four strictest" requirements for drug safety, strengthen the publicity and implementation of the newly revised Drug Management Law, further strengthen supervision and inspection, urge the continuous compliance of enterprises' production and operation behaviors, strictly investigate and deal with all kinds of illegal behaviors according to law, and effectively maintain the drug safety of the masses It is hereby announced State Food and drug administration, November 29, 2019, March 7