China will further strengthen the supervision of chemical APIs

Shao Mingli, director of the State Food and drug administration, said at the national food and drug administration working conference on January 30 that China will further strengthen the supervision of chemical APIs and take it as one of the measures to consolidate the achievements of the special treatment of drugs It is understood that further strengthening the supervision and control of chemical raw materials drugs will focus on two issues: one is the problem of illegal production of chemical raw materials drugs by chemical enterprises; the other is the problem of illegal use of chemical raw materials drugs produced by chemical enterprises to directly produce drugs by drug manufacturers According to Bian Zhenjia, director of the Department of drug safety supervision of the State Food and drug administration, strengthening the supervision of chemical APIs will mainly start from three aspects: first, comprehensively investigate the production of APIs in chemical enterprises That is to say, in view of the problem that the production * purpose of chemical enterprises is pharmaceutical raw materials or the production of chemical raw materials directly for the use of pharmaceutical production enterprises, in conjunction with the national development and Reform Commission and other departments, we will conduct a comprehensive investigation on the production of chemical raw materials in chemical enterprises, and find out the production enterprises, varieties, quantities, sales, etc of such products On this basis, relevant policies shall be formulated to include those conforming to the requirements of drug management into drug supervision, and production can only be organized by obtaining drug production license, GMP certificate and drug approval number of relevant varieties Those who do not meet the requirements of drug administration shall be banned Second, strengthen the supervision of drug production, and prohibit drug manufacturers from using the chemical raw materials produced by chemical enterprises directly in the production of pharmaceutical preparations in violation of regulations Third, catalogue management shall be implemented for the export of chemical drugs, including chemical raw materials The varieties included in the catalogue of exported drugs must be registered and their production enterprises must obtain a drug production license.