China Aims To Synchronize With Global Drug Approvals By 2025
China’s new Five-Year Plan for drug quality aims to address hurdles in clinical study ethics committee review while leaving out other restrictions including genetic material export and substandard clinical sites.
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China provides some long-awaited clarifications regarding the review and approval of international multi-center clinical trials but some groups are still calling for further steps.
A revised regulatory approach in China will include rolling data submissions among new incentives for the development of innovative new drugs in a bid to further accelerate the approval of such products.
Brian Yang, Dexter Yan and guest speaker Kevin Grogan from the UK discuss Shanghai's latest policy to spur biopharma investment, the US House's recent draft bill to restrict bio service providers from China, and multinationals' strategies in China and views on Chinese innovation.