China is looking to speed up approvals for new drugs and plans to accept data from clinical trials carried out overseas, a potential boon for international drug makers and patients who often face lengthy delays for new medicines to reach the market.
The move, announced by the cabinet late on Sunday, said foreign drug trial data would be accepted in a bid to accelerate approvals and help China close an innovation gap with developed international markets.
“Clinical trial data from overseas centres that complies with Chinese drug and medical device registration requirements can be used to make registration applications in China,” the draft proposals posted on the State Council’s website said.
Demand for new therapies is surging in China due to an ageing population and rising incidence of chronic diseases such as cancer and diabetes, and the faster approvals are likely to provide a boost to multinationals like Pfizer, AstraZeneca and GlaxoSmithKline, who are expanding there. China spent US$116.7 billion on medicine in 2016 and the market is second only to the US in size, according to researcher QuintilesIMS.
Generally, draft proposals announced in China are later implemented much as they first appear.
The move should help speed up approvals in the world’s second largest drug market, after the United States, where global firms have faced rising challenges from Chinese rivals and authorities are keen to squeeze down prices.
“For multinational and leading local innovative drug makers, the anticipated acceleration of approval will improve patients’ access to new medicine and increase revenues for pharmaceutical companies,” said Jialin Zhang, senior health care analyst at ICBC International Research.
The China Food and Drug Administration has conducted bold reforms in recent years, and the latest policy appears to have received the blessing of top levels of the central government, Zhang said. Reforms “will help the industry select its fittest for survival and improve its overall competitiveness”, he said.
The proposal said that firms looking to register drugs or medical devices for the first time would need to provide clinical trial data related to any racial divergence relevant to the Chinese market.
The announcement comes as China aims to boost its drug industry and support a shift from generic drugs and towards more innovative medicines and medical equipment – a trend that raises a longer term challenge to global firms.
The State Council added that the changes would make China’s industry more competitive and help meet the clinical needs of its nearly 1.4 billion people, for whom high costs and access to health care are significant issues.
“Overall, China’s support for scientific innovation with drugs and medical devices is lacking, and the quality of products on the market still falls short of top international levels,” the central government body said.
“We must speed up the examination and approval of urgently needed drugs and medical devices,” it added.