Now Is The Time! Rule Changes To Smooth China New Drug Approvals?
The China FDA has outlined a raft of new measures to streamline the development and approval process for foreign new drugs, in changes that are likely to quicken the pace of launches to potentially overcome China’s “drug lag” and that may also bolster multinationals’ interest and activity in the country.
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The China FDA releases a raft of new regulatory proposals outlining fundamental changes in areas including patent linkage and data exclusivity, which look set to profoundly impact decision makers looking at bringing new drugs and devices to the world’s second-largest pharma market.
In a major show of force, four global pharma CEOs are heading to China to participate in high-level open and closed-door discussions that are expected to include a range of policy and regulatory reform topics. Tapping into China’s push to improve health and develop an innovation-driven economy may provide new openings for their voices to be heard.
China’s drug regulators have had plenty of views to offer at recent major government congress sessions in Beijing, which provide a forum for the industry to meet officials and opportunities to outline reform progress and planned policies.