Pharmaceutical companies will soon be able to import raw materials for traditional Chinese medicine without requiring authorization from the top drug authority.
Instead, importers－including TCM producers and sellers－need only apply to provincial-level drug authorities for approval the first time they import from a country or region, according to a new regulation released by the National Medical Products Administration last week and to be adopted on Jan 1.
Afterward, they can just register with authorities in the ports certified for drug import, or with drug authorities in places that have jurisdiction over these ports before importing the raw materials, the regulation said.
Currently, importers have to apply to the National Medical Products Administration for approval every time they import TCM raw materials.
Simplifying the procedure will be more convenient to importers and save their time, the administration said. After the revised regulation is adopted, approval procedures for each import of TCM raw materials will take 20 working days at most, half the current time, it said.
“With the regulation adopted, enterprises across China will not have to come specially to Beijing to get imports approved,” said Yu Zhibin, chief for TCM at the China Chamber of Commerce for Import and Export of Medicines and Health Products.
Yu said China relies on imports for many kinds of TCM raw materials, and the new measures will encourage more enterprises to import, which will boost the development of TCM.
The revised regulation also intensifies supervision over the quality of TCM drug materials to ensure safety and quality, including strengthening sample checks at ports, improving traceability and information sharing between departments, the administration said.
China imported 91,000 metric tons of raw materials for TCM in 2017, an increase of 13.6 percent compared with the previous year, while exports exceeded 223,000 metric tons, a rise of 9.5 percent year-on-year, according to a report released by the Ministry of Commerce last year.
Total value of TCM raw material imported last year was $261 million, an increase of 29.7 percent year-on-year, the report said.
Major sources of import of TCM raw materials were Asian countries, including Thailand, Indonesia and Iran. The major imports included longans, ginseng and crocus, the report said.