The Department of General Affairs of the National Medical Products Administration ("NMPA") and the Department of General Affairs of the State Administration of Science, Technology and Industry for National Defense ("SASTIND") have recently issued the Circular on Working Effectively on Examination and Approval of Radioactive Drug Manufacturers and Distributors (the "Circular").
According to the Circular, from December 1, 2019, the provincial drug regulators and the local administrations of science, technology and industry for national defense, in the locality of the pilot free trade zones in Shanghai, Guangdong, Tianjin, Fujian, Liaoning, Zhejiang, Henan, Hubei, Chongqing, Sichuan, Shaanxi, Hainan, Shandong, Jiangsu, Guangxi, Hebei, Yunnan and Heilongjiang, shall be responsible for examination and approval of radioactive manufacturers and distributors within the free trade zones. The Circular further clarifies that, for the establishment a radioactive drug manufacturer or distributor within the free trade zone, application documents shall be submitted to the provincial drug regulator in its locality. The provincial drug regulator in its locality, in concert with the local administration for science, technology and industry for national defense, will, by reference to relevant requirements set out by the Administrative Measures for Radioactive Drugs, examine the application documents submitted by the enterprise, and decide on whether to grant approval in consideration of findings of the examination and on-site inspections.