China considers ways to speed up time to market for imported drugs


Reuters

CORRECTED-China considers ways to speed up time to market for imported drugs


(Corrects number of months in paragraph six to 10 from 16)
    BEIJING, March 20 (Reuters) - 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-centre
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
authorisation once completing international multi-centre
clinical trials, the document said.
    High drug costs and a lack of access to the most recent
treatments is a major flashpoint in China, where patients often
are forced to resort to risky grey markets to get cheaper
medicines. [nL4N1EL2NW]
    Imported drugs face 3-4 years of reviews on average before
being allowed into the Chinese market, compared with about 10
months in the United States, Chinese newspaper The Paper
reported on Monday.
    Last month, the government updated its list of medicines
covered by basic medical insurance schemes, a long-awaited
fillip for drugmakers in the world's second-largest drug market
where many new drugs have been kept out of patients' reach
because of high costs. [nL4N1G824C]

 (Reporting by Muyu Xu and Brenda Goh; Editing by Stephen
Coates)
 ((muyu.xu@thomsonreuters.com;))

Keywords: CHINA PHARMACEUTICALS/ (CORRECTED)



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