Nod for drug licensing reform
Print Edition
A PROPOSAL on experimental changes to the drug licensing system was adopted by China鈥檚 top legislature yesterday, aiming at promoting pharmaceutical innovation and better quality by giving more incentive to researchers.
Under the three-year experiment, drug research and development agencies and researchers can directly apply for licenses to mass produce drugs they have developed. Previously, only drug manufacturers could apply for licenses and researchers were required to transfer their results to the producers.
The uncertainty over licensing results put researchers at a disadvantage in their negotiations with drug companies, making them less motivated in their job, Bi Jingquan, head of the China Food and Drug Administration, told lawmakers.
Lawmakers voted on the proposal at the closing meeting of the bimonthly session of the National People鈥檚 Congress Standing Committee.
The experiment, taking effect from today, will be piloted in 10 regions, including Beijing, Shanghai, Zhejiang, Guangdong, Shandong and Sichuan.
The proposal says the reform aims to narrow the gap of pharmaceutical development between China and developed countries and promote China-made generic drugs globally.
鈥淭he quality of some generic drugs lags far behind their international counterparts,鈥 a problem which reforming the licensing system could address, Bi said.
After three years, the State Council will submit a report on the experiment to the legislature, which decide whether to formally revise the law or not.
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