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Norme Dogane e Valute

21 MARZO 2017

05:20 - Cina

CHINA CONSIDERS SPEEDING UP DRUG APPROVALS

(ICE) - ROMA, 21 MAR - China is considering taking measures that will shorten the time to market for approved imported drugs in an effort to ease a shortage of such medicines, according to the China Food and Drug Administration (CFDA). The proposed changes to current clinical trial requirements were in response to public demand for new drugs, the CFDA said in a document published on its website on Friday. The CFDA proposes eliminating a requirement asking applicants who intend to conduct an international multi-center clinical trial in China for drugs apart from vaccines to obtain prior foreign approval or be currently in phase II or III clinical trials overseas. Imported drugs would be allowed to directly apply for market authorization once completing international multi-center clinical trials, the document said. (ICE SHANGHAI)

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