China Waives Overseas Trial Requirement for Pharmaceuticals

In an attempt to segway innovative drugs into the international market, China plans to accept data from overseas to speed up pharmaceutical approvals.

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The new legislation allows pharmaceutical companies to by-pass up to seven years delay which required overseas clinical trials reach a mature stage before Chinese trials could begin.

Per a statement made by Cabinet late Sunday, certain companies can avoid Chinese trials altogether, gathering the necessary information from foreign partners.

“This will be a positive factor for the approval of overseas companies’ innovative drugs in China,” said Li Yin of Clarivate Analytics, a research group. “The long backlog of products awaiting approval has a chance to be cleared more quickly.”

The move seeks to address high medical costs and access to healthcare for China’s population of nearly 1.4 billion. In the past five years, China has approved just over 100 innovative new drugs, about one-third the number in developed markets.

“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 draft proposals said.

“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,” Wu Zhen, deputy head of the China Food and Drug Administration, told a briefing on Monday.

A number of drugs have been in circulation for over six or seven years before making to China’s market, Wu said.

Pharmaceutical agencies will have to wait to discover the details behind accessing new legislation, but experts speculate it will have to do with including a specific number of persons of Asian or Chinese descent in their trial processes.

According to Wang Lifeng of the Chinese Food and Drug Administration, the use of clinical data will be determined based on the results from these “eastern” trial groups.

In March, China proposed ways to speed up approvals for imported drugs, including reforming clinical trial requirements. It also wants to boost its own drug industry and see a shift from generic drugs and towards more innovative medicines and medical equipment.