ABSTRACT
This chapter illustrates the regulatory considerations for the implementation of the ICH E17 guideline in China that was released in 2019. Chinese regulators encourage the sponsors to apply the general principles in the guideline when multi-regional clinical trials (MRCTs) are planned and designed. This chapter discusses some common issues and challenges in practice encountered by the reviewers in the agency, like the totality of the evidence, pooling strategy, study with local enrollment extension, etc.
