Guide­line speeds ac­cess to drugs

China Daily European Weekly - - News Digest -

Drugs de­vel­oped in other coun­tries are ex­pected to be avail­able for use on the Chi­nese main­land more quickly un­der a new guide­line re­leased by the cen­tral govern­ment. Au­thor­i­ties in China will now ac­cept data col­lected from clin­i­cal tri­als con­ducted out­side the main­land for ap­pli­ca­tions to reg­is­ter drugs and med­i­cal equip­ment, ac­cord­ing to the guide­line on re­form­ing ap­proval pro­ce­dures, which was re­leased by the State Coun­cil. The data must be col­lected from clin­i­cal tri­als con­ducted at more than one cen­ter and must meet Chi­nese reg­u­la­tions for regis­tra­tion of drugs and med­i­cal equip­ment, the guide­line said. Un­der cur­rent reg­u­la­tions, food and drug au­thor­i­ties can­not ac­cept clin­i­cal trial data col­lected from over­seas, and new drugs be­ing de­vel­oped over­seas should fin­ish their first phase of clin­i­cal tri­als over­seas be­fore de­vel­op­ers can ap­ply to start clin­i­cal tri­als on the main­land, ac­cord­ing to Wu Zhen, vice-min­is­ter of the China Food and Drug Ad­min­is­tra­tion. This has de­layed the avail­abil­ity of some ma­jor drugs on the Chi­nese mar­ket, he says.

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