China mulls ways to speed up time imported drugs can go on the market
Aim is to ease shortages of supplies of some medicines on the mainland
China is considering taking measures to shorten the time to market for approved imported drugs in an effort to ease a shortage of the medicines, according to the China Food and Drug Administration.
The proposed changes to current clinical trial requirements were in response to public demand for new drugs, the administration said in a document published on its website.
The body 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 16 months in the United States, the Chinese news website The Paper reported on Monday.
The government has 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.