Approval for Radioactive Drug Production and Sale Delegated to Provincial Level

The National Medical Products Administration and the State Administration of Science, Technology and Industry for National Defencerecently issued a notice (No. 22 [2020]) on the approval of enterprises that produce and sell radioactive drugs. The following are the main points of this notice:

• From 1 December 2019, the provincial-level drug regulatory department and local administration of science, technology and industry for national defence in the 18 pilot free trade zones are responsible for the approval of enterprises producing and selling radioactive drugs in the free trade zones.

• Enterprises that produce and sell radioactive drugs in the free trade zones have to submit the required materials to the local provincial-level drug regulatory department when applying for permits for the production and sale of radioactive drugs. The local drug regulator examines the submitted application materials in accordance with the Measures for the Administration of Radioactive Drugs in conjunction with the local administration of science, technology and industry for national defence, organise on-site inspection in accordance with the relevant provisions of the good supply practice for drug manufacturing, and decide whether or not to grant approval based on the result of examination and on-site inspection.

Source: National Medical Products Administration