China Speeds Review Procedures for Approval of Orphan Drugs

Eager to hasten the availability of medicines for rare diseases and life-threatening illnesses to Chinese consumers, China is easing approval procedures for orphan drug imports. At a meeting this summer, the China State Council set a review timeline of just three months for imported orphan drugs that have already been approved in Western foreign markets to treat rare diseases. Therapies to treat life-threatening diseases will have a review timeline of six months.

The new policy will permit new drugs that are already tested and sold overseas to be cleared for quick entrance to the Chinese market. It is the latest in a series of moves affecting medicines considered in urgent need for Chinese consumers.

At the same meeting, Chinese authorities took steps to expand pharmaceutical reserves, reduce prices for cancer treatments, and establish an alert system to prevent supply shortages of essential drugs. In late spring, the Chinese government published its first national list of rare diseases. And earlier this year, the China Drug Administration took the first step to expand data exclusivity—the protection of clinical data submitted by one pharmaceutical developer from use by others—to a broader range of pharmaceuticals.