China Issues Draft Circulars on Conditional Drug Approvals

The China Food and Drug Administration (CFDA) has proposed two draft circulars on conditional approvals for urgently needed drugs and the compassionate use of investigative drugs in China. The two drafts, if approved, would increase market access for new drugs and innovative therapies—part of recent government moves to encourage healthcare innovation. Under the guidelines, conditional approval could be given to drugs not available in China that can treat severe or rare illnesses. Conditional approval for early marketing could be given if early or mid-stage data indicate a drug’s efficacy. It could also be given to “orphan” drugs marketed outside China. The drafts also outline specific conditions under which patients could be eligible for compassionate use of investigational drugs.