China drafts guidelines for use of real-world data

Five months after FDA released a framework for use of real-world data in drug development, China’s Center for Drug Evaluation followed with its first guidelines for the data in May, which the country’s large population may uniquely position it to utilize for drug development and regulatory decisions. By clarifying the government's position, the draft guidelines could incentivize industry use of the data.

The draft outlines several scenarios that could utilize real-world evidence (RWE), including postmarketing evaluation, label expansion, drug combination labeling, control arms in rare disease trials, supplementing clinical trials of traditional medicines with historical usage data, guiding clinical trial design and identifying target populations for precision medicine...