China raising regulations over radioactive drugs



China is finessing oversight on radioactive pharmaceuticals. According to a joint notification by the National Medical Products Administration (NMPA) and State Administration of Science, Technology and Industry for National Defense, manufactures and operators of radioactive drugs will undergo a more rigorous regulatory process.

The companies that file for such matters in free trade zones (FTZs) in Chongqing, Fujian, Guangdong, Guangxi, Hainan, Hebei, Heilongjiang, Henan, Hubei, Jiangsu, Liaoning, Shaanxi, Shandong, Shanghai, Sichuan, Tianjin, Yunnan, or Zhejiang, will have to be checked and reviewed on the spot by the provincial medical products administrations (MPAs) and national defense local science and technology units. Those outside FTZs will submit filings to the provincial drug administrations, who will issue an examination opinion and report to the NMPA. Approved manufacturers will receive a permit from the provincial MPAs, valid for five years.

Radioactive drug manufacturing licenses and business licenses are printed by the NMPA, but processed by MPAs.

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