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 authorization 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.
Now it’s clear that when China’s FDA director Bi Jingquan promised to speed up foreign drug approvals in China a few days ago during the country’s annual congress sessions, the agency already had its plans sketched out.
“When finalized and implemented, these policies will encourage biopharmaceutical innovation and accelerate the approval process for new medicines,” Pfizer said in a meeting with Corporation China. “They will also pave the way for China’s integration into the system for multi-regional clinical trials that undergirds global drug development.”
But why would these changes mean so much for foreign pharmas? “Before expanding to new markets, companies develop businesses plans, strategies, allocate resources and staff, among many other factors. Having to wait years before receiving a license for sale is a luxury that many companies can not afford, a fast moving Chinese policy on drugs will be crucial to determine pharmas future growth without compromising one of the most valuable assets in today’s business environment: time.” states Arnodo Neto, Regional Manager at Corporation China in Shanghai.