China Overhauls Drug Approvals in Win for Global Pharma

China is revamping its approval system for medicines and medical devices to speed up access to new therapies, a potential boon for local innovators and international drugmakers expanding in the world’s second-largest pharmaceutical market.

Data from overseas clinical trials will be accepted for drug registrations in China, according to a statement from the State Council, China’s cabinet, published by the official Xinhua news agency.

The changes will likely cut delays in approvals for new treatments by several years and free foreign drug makers from requirements to conduct expensive late-stage clinical tests on Chinese patients.

Demand for new therapies is surging in China due to an aging 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 $US116.7 billion on medicine in 2016 and the market is second only to the US in size, according to researcher QuintilesIMS.

Shares of Chinese drug makers researching new medicines also jumped on Monday. Jiangsu Hengrui Medicine Co. surged as much as 6.5 per cent and Shanghai Fosun Pharmaceutical Group Co. added as much as 6.1 per cent.

“For multinational and leading local innovative drugmakers, 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.

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Change was Signalled

The changes had already been widely telegraphed by the Chinese government, which earlier this year said it was considering overhauling the approval process.

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, said Zhang.

Reforms “will help the industry select its fittest for survival and improve its overall competitiveness,” he said in an e-mail.

The reforms also include measures to speed up approvals for clinically needed drugs and equipment, establish a compulsory-licensing system and make it easier for research institutions to conduct clinical trials, according to the document.

The government will also explore a slew of rules to protect patents.


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