BioCentury
ARTICLE | Politics & Policy

China accelerates drug review timelines for rare, life-threatening diseases

June 22, 2018 9:22 PM UTC

The China State Council set new policies to speed drug approvals, accelerate price cuts and market access for cancer drugs, and monitor and increase drug supplies.

The changes include setting a review timeline of three months for imported drugs approved overseas to treat rare diseases and six months for therapies to treat life-threatening diseases. Foreign clinical data may be used directly in these regulatory submissions. Additionally, samples of imported drugs will be tested after listing instead of prior to registration...