China to accelerate drug approvals with overseas trial data

pharmafile | October 9, 2017 | News story | Research and Development, Sales and Marketing China, drug approvals, pharma, pharmaceuticals 

In a bid to speed up access to medicines for patients, China has revealed it intends to incorporate data from clinical trials conducted overseas into its approval process for new drugs, meaning international manufacturers and patients alike could face less delays in the world’s second-largest pharmaceutical market.

China’s process for authorising new drugs is known to be problematic compared to other developed markets, approving around 100 new drugs in the past five years – around two-thirds less than comparable nations. With a population of 1.4 billion, the country has also been grappling with high medical costs for its citizens. 

This divide between China and other nations was a driving factor in the draft proposals outlining the plan: “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. We must speed up the examination and approval of urgently needed drugs and medical devices,” the documents read.

The proposals, announced by the State Council, come just days before the 19th Congress of the Communist Party this week. In practice, they will mean that drug makers will no longer need to conduct additional trials in the country after receiving approvals elsewhere, potentially cutting years from the time it takes a drug to reach market.

“We want to make our drug industry large-scale and strong, make it more competitive, and shift our long-term reliance on imports of new drugs,” commented Wu Zhen, Deputy Head of the China Food and Drug Administration. “Some drugs have been used overseas for six to seven years before making it to market in China.”

Matt Fellows

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