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.
In the latest venture capital and private equity funding deals in China, SanegeneBio, Argo Biopharma and Ausper Biopharma raised a combined $136m on the back of their early-stage small interfering RNA and antisense oligonucleotide assets.