Imported chemical raw materials and preparations are no longer mandatory for batch inspection

On May 3, the State Drug Administration issued an announcement to clarify the relevant matters relating to customs clearance of imported chemicals: Imports of chemical substances and preparations (excluding chemical products sold in China for the first time) Mandatory inspection. The drug regulatory authority at the port where the importation of chemical drugs is filed will no longer issue the "Notice of Inspection of Imported Drugs at Ports" and the Port Drug Control Office will no longer conduct port inspections on imported chemical drugs.

Clear announcement, import drug The holder of a marketing license must manufacture, sell and distribute imported pharmaceuticals. Adverse reactions The report assumes all legal responsibilities. It should ensure that the production process continues to be compliant, as well as conduct continuous research on the listed drugs to ensure the quality and safety of the drugs. Holders of imported drug marketing licenses should submit to the China Food and Drug Testing Institute in accordance with relevant regulations. standard substance.

For the supervision and inspection of imported drugs, the announcement requires that drug regulatory authorities at all levels should strengthen the supervision and inspection of imported drugs for market surveillance, strengthen supervision and inspection, and investigate violations of laws and regulations in strict accordance with the law. The drug regulatory authorities at the ports where the drugs are located should comply with relevant regulations. The summary of import drug registration information was submitted to the China Food and Drug Testing and Research Institute. The sampled imported chemical inspection tasks were completed before the announcement date. The port drug inspection agencies continued to carry out the inspection according to the original regulations.