China will accept data from overseas clinical trials to hasten drug approvals

China pharmacy

Access to medicines could be hastened in China after the country’s government said it planned to accept data from overseas clinical trials for the first time.

The move is intended to address the high costs of medicines and make access to healthcare for China’s 1.4 billion population more comparable with international levels of access to drugs. Global pharmaceutical firms face growing competition and pressure from Chinese firms to keep prices down.

The draft proposals from the State Council of the People’s Republic of China said approval for urgently needed drugs and medical equipment should become faster. The proposals include creating a catalogue of marketed drugs, improving the protection of drug trial data and building a system linking drug approvals and patient access to data. They also proposed increasing the number, and improving the quality, of clinical trial testing centres in China.

“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,” said a Council statement.

The world’s second largest pharmaceutical market, China, has increasingly opened up to new drugs over the past five years. In that time, 100 new drugs have been approved — around a third of those generally approved in most healthcare markets.

No details were given on a timeline for implementation for the proposals.

“We want to make our drug industry large scale and strong and shift our long-term reliance on imports of new drugs,” deputy head of the China Food and Drug Administration Wu Zhen said on Monday 9 October. “[Some drugs] have been used overseas for six to seven years before making it to [the] market in China.”

Last updated
The Pharmaceutical Journal, China will accept data from overseas clinical trials to hasten drug approvals;Online:DOI:10.1211/PJ.2017.20203714

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