China to speed up approvals for new drugs and plans to accept foreign trial data
Move is likely to provide a boost for global pharmaceutical companies and reduce delays for patients awaiting new medicines
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.
