New medicine, new rules

Guide­lines help stim­u­late Shang­hai’s in­no­va­tion in med­i­cal fields

Global Times – Metro Shanghai - - FRONT PAGE - This story was trans­lated based on a re­port by Shang­haifabu.

The Shang­hai Mu­nic­i­pal Gov­ern­ment re­leased 32 new guide­lines re­lat­ing to the city’s drug and med­i­cal en­ter­prises on Wed­nes­day, an at­tempt to fur­ther bring out these en­ter­prises’ cre­ativ­ity and de­vel­op­ment, and to im­prove the city’s com­pet­i­tive­ness in the drug and med­i­cal fields to the high­est in­ter­na­tional level, ac­cord­ing to the mu­nic­i­pal gov­ern­ment.

The guide­lines fo­cus on re­forms in six as­pects. One is about the re­form of clin­i­cal test man­age­ment. Lo­cal au­thor­i­ties have de­cided to al­low for­eign med­i­cal in­sti­tu­tions to carry out clin­i­cal tests syn­chronously in Shang­hai; it will also crack down on data fraud in clin­i­cal tests.

The sec­ond as­pect of the guide­lines is about ac­cel­er­at­ing the ap­pli­ca­tion of drugs and med­i­cal equip­ment on the mar­ket. No­tably, drugs and med­i­cal equip­ment ur­gently needed by the mar­ket can now en­joy a “green chan­nel” for faster ap­proval.

The lo­cal au­thor­ity also launched a one-stop ser­vice plat­form on­line, which al­lows en­ter­prises to han­dle ap­provals on­line in­stead of vis­it­ing dif­fer­ent gov­ern­ment de­part­ments off­line.

The third as­pect of the guide­lines is about turn­ing Shang­hai into a global leader in bi­o­log­i­cal medicine in­no­va­tion and re­search. A patent data­base of drug and med­i­cal equip­ment will be es­tab­lished for bet­ter patent pro­tec­tion. Com­pa­nies are also en­cour­aged to in­crease their in­vest­ment in med­i­cal re­search.

Su­per­vi­sion and re­spon­si­bil­ity

Uni­ver­si­ties and med­i­cal re­search in­sti­tutes are now al­lowed to keep most of the fi­nan­cial prof­its in their sci­en­tific find­ings. Some new drugs in can­cer treat­ment and ad­vanced med­i­cal equip­ment in overseas mar­kets will be al­lowed to be ap­plied into use in fixed points in Shang­hai.

The fourth area is about tight­en­ing reg­u­la­tions and su­per­vi­sion on the full life cy­cle of drugs and med­i­cal equip­ment. No­tably, a pun­ish­ment sys­tem that traces back to spe­cific in­di­vid­u­als will be launched.

The guide­lines also stress es­tab­lish­ing new in­sti­tu­tions, tal­ent teams, data shar­ing sys­tem and pro­mot­ing re­gional and in­ter­na­tional co­op­er­a­tion in the fields of drugs and med­i­cal equip­ment, to pro­vide bet­ter tech­ni­cal and sys­tem­atic sup­port to the in­dus­try.

The sixth as­pect is about the re­form of gov­ern­ment de­part­ments cov­er­ing drug and med­i­cal equip­ment is­sues. Clear re­spon­si­bil­i­ties will be al­lo­cated to re­lated de­part­ments.

Photo: VCG

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