China to keep drug approvals on lockdown - expert
Shanghai. May 18. INTERFAX-CHINA - China's State Food and Drug Administration (SFDA) is set to continue its strict drug approval policies, especially for generics, an expert said at the third Drug Information Association (DIA) China Annual Meeting in Beijing on May 17.
"The SFDA hopes to curb imitation and encourage innovation through this approach," said Wu Zhi'ang, director of the School of Business Administration of Shenyang Pharmaceutical University.
Government-mandated price cuts are also helping encourage drug makers to develop new products, Wu said.
The number of drugs approved by the SFDA has plummeted in the past five years as the regulator drastically tightened registration procedures. The body approved only 886 drugs in 2010, of which 651 were generic, down from 11,086 in 2005, 8,000 of which were generic.
"On-site inspections are becoming more systematic so more drugs fail to make it through the approval process," he said.
China is also working to bring its technical guidelines for drug registration into line with international standards, Wu said.
The country plans to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), Sun Xianze from the SFDA's drug safety supervision department said in Beijing in February. These are two international instruments meant to improve cooperation between different regulatory authorities and the pharmaceutical industry.
And in 2009, the SFDA set up a body to translate guidelines from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICT), a global project that aims to standardize registration procedures for pharmaceutical products.
The SFDA's body, comprised of experts from the National Institutes of Food and Drug Control (NIFDC), the Center for Drug Evaluation (CDE) and the RD-based Pharmaceutical Association Commerce (RDPAC), has translated 22 ICH guidelines so far.
"These translations will be published this year," Maggie Chang, director of RDPAC, said at the meeting May 17.
According to Wu, other notable trends in China's drug registration procedures include the application of dimethylformamide (DMF) techniques in the regulation of active pharmaceutical ingredients, and better communication between the general public and the authorities and pharma firms.
- KZ
