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FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval.

China’s ambition to become a leader in the biopharma industry has been clear in the last few years. The investment flowing into the sector is not limited to just the development of medicines, there has also been a focus on rapidly developing capability and capacity to manufacture both traditional pharmaceuticals and biologic medicines.

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