Big push for homegrown innovative medicines

The National Medical Products Administration, China's top drug regulator, says it will redouble efforts to facilitate research and market registration of homegrown innovative drugs, while speeding up the introduction of novel foreign drugs to the domestic market to meet public demand.

From January to August, the administration approved 31 innovative drugs, a rise of nearly 20 percent from the same period last year, Li Li, the director of the administration, told a recent news conference in Beijing.

It also granted market clearance to 46 innovative medical devices during the same period, a year-on-year increase of more than 12 percent.

"In the meantime, progress has been made for domestic novel medicines such as molecular targeted therapy, immunotherapy and cell therapy to obtain market registration overseas, while domestic products are gaining increased recognition in the global market," he said.

Li added that homegrown, high-end medical equipment, such as surgical robots, artificial hearts and carbon ion treatment systems used to treat some cancer patients, have been approved in recent years, with some being of world-leading quality.

Li said the administration will continue to expedite market application procedures for medical products that can fill unmet, urgent medical needs. In Beijing, Shanghai and other regions, trial programs are underway to halve review periods for innovative medications from 60 to 30 working days.

"To advance opening-up in the pharmaceutical industry, we will also strengthen implementation of common international regulatory rules, support rollouts of international multi-center clinical trials and promote simultaneous research and review of global drugs in China," he said.

Li added that efforts will be made to explore segmented production of biological products, encourage international drugmakers to transfer manufacturing capacity of novel and high-end medical products to China and accelerate foreign novel drugs' market registration for the domestic market.

Regarding the supervision of drug production, the administration said that in the first eight months of the year it had carried out around 21,000 spot checks on drug manufacturers, with a pass rate of 99.43 percent.

wangxiaoyu@chinadaily.com.cn