China considers ways to speed up time to market for imported drugs
BEIJING – China is considering taking measures that will shorten the time to market for approved imported drugs in an effort to ease a shortage of such medicines, according to the China Food and Drug Administration (CFDA).
The proposed changes to current clinical trial requirements were in response to public demand for new drugs, the CFDA said in a document published on its website on Friday.
The CFDA proposes eliminating a requirement asking applicants who intend to conduct an international multi-center clinical trial in China for drugs apart from vaccines to obtain prior foreign approval or be currently in phase II or III clinical trials overseas.
Imported drugs would be allowed to directly apply for market authorization once completing international multi-center clinical trials, the document said.
High drug costs and a lack of access to the most recent treatments is a major flashpoint in China, where patients often are forced to resort to risky gray markets to get cheaper medicines.
Imported drugs face 3-4 years of reviews on average before being allowed into the Chinese market, compared with about 10 months in the United States, Chinese newspaper The Paper reported on Monday.
Last month, the government updated its list of medicines covered by basic medical insurance schemes, a long-awaited fillip for drugmakers in the world’s second-largest drug market where many new drugs have been kept out of patients’ reach because of high costs. –Reuters