China NMPA expands on review timeline for new imported drug pathway

China’s National Medical Products Administration will decide whether to approve applications for certain imported drugs that have been approved in the U.S., EU or Japan within 10 business days after the agency's Drug Review Center completes its review.

The guidance applies to drugs that have been approved in at least one of the three territories for nearly a decade to treat rare diseases, or life-threatening diseases for which there is no effective alternative or the drug has a clear clinical advantage...