China considers ways to speed up time to market for imported drugs
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.
The CFDA proposes eliminating a requirement asking applicants who intend to conduct an international multi-centre 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 authorisation once completing international multi-centre 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 grey markets to get cheaper medicines.
Imported drugs face three to four years of reviews on average before being allowed into the Chinese market, compared with about 10 months in the US, Chinese newspaper The Paper reported yesterday.
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.