Full article reprinted from "PharmAsia News" November 19, 2008
Read about why China's State FDA will launch a new fast-track mechanism by year end called the special approval procedure for drug registration to accelerate drug registration...
Full article reprinted from "PharmAsia News" November 19, 2008
China Will Issue New Fast-Track Procedure For Drug Registration: CDE Official
China's State FDA will launch a new fast-track mechanism by year end called the special approval procedure for drug registration to accelerate drug registration, SFDA Center for Drug Evaluation Official Yi Feng, told China Trials 2008 attendees here Nov. 10.
China issued a first draft of the special approval procedure on its Web site last October and released the revised final draft for public comment Oct. 6. The special procedure aims to promote new drug innovation and ensure drug safety, according to SFDA.
China still does not allow Phase I global clinical trials to be conducted in China, according to Feng, who is director of review management and coordination in SFDA's Center for Drug Evaluation. "The earlier phase we enter clinical trials means we may face more risks. China has not set up sufficient risk-control systems to meet requirements [for Phase I trials]," Feng said.
China considers drugs marketed in other countries as "new drugs" in China and requires additional clinical trials to be conducted in China to gain marketing approval there. Companies must get clinical trial authorization from China's State FDA to conduct global late-stage trials.
The number of applications for global clinical trial authorization in China has increased to 70 cases in 2007 from three cases in 2002, when China began to participate in global clinical trials. The number of applications approved by China has also increased to 53 in 2007 from zero in 2002, Feng noted.
The technology review of most clinical trial authorizations for global trials were completed in four to seven months, but still some applications take longer than seven months, he said. In the U.S. and Europe it takes one to three months to get approvals from regulatory authorities to begin clinical trials.
Staff shortages at SFDA and CDE were cited as the main reason for the longer authorization periods, according to Feng.
"There are 118 employees working for CDE now. We would like to recruit and enforce our team, but due to China setting a ceiling for staff numbers working for government departments, it is hard for us to recruit more investigators," he said.
In addition, poor communication during the pre-IND phase means that China cannot take part in earlier stage drug development, Feng said.
"SFDA is taking too much responsibility during the drug approval procedure," he said. China needs to set up an accountability system for sponsors and CRAs [Certified Research Administrator] to strengthen data management, issue more specific guidelines and improve the communication system and project management."
To that end, video conference rooms have been equipped in CDE's new building, which should make it easier for reviewers to communicate with sponsors, he noted.
- Jialing Dai
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