China Sets Norms For Foreign Trial Data Submissions

24 Oct 2017

China's latest draft rules set conditions for accepting foreign clinical study data, discouraging ‘selective filing’. Experts see enhanced opportunities for international drug makers to register new products, especially drugs to treat critical, pediatric and rare diseases.

female scientist working with microscope — Clinical research

China FDA released on Oct. 20 a new draft pertaining to clinical trial data that specifies requirements for foreign drug makers to use study data obtained outside China towards a new product approval in China.

Per the draft, data from a global parallel study or multi-regional clinical trial (MRCT) can be used towards a product...