LS&HC Horizons 2022 - Flipbook - Page 53
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
Asia-Pacific
Use of Real-World Evidence for the registration of
medical devices and drugs in China
Real-World Evidence (RWE) has been allowed to be used as
supplemental evidence of clinical evaluations in the registration
for market authorization of medical devices (including in vitro
diagnostics) and drugs with the National Medical Product
Administration (NMPA) in China since 2019.
In particular, as a pilot project, the unregistered foreign medical
devices and drugs (with home country approval having been
obtained) in urgent clinical needs can be imported and used
in designated medical institutions in Hainan Boao Lecheng
International Medical Tourism Pilot Zone (Boao) through the
special approval from the local authorities, in order to generate
the real-world data which could then turn into RWE to the benefit
of subsequent product registration with the NMPA. Typically,
using RWE for market authorization application will shorten the
registration approval time of products in China.
So far, the NMPA has approved the market authorizations of one
ophthalmic medical device from each of Ireland and U.S., and one
U.S. drug, all of which were applied by using the RWE generated
in Boao pilot as the supplemental evidence for the registration.
Jessie Xie
Counsel, Beijing
Carol Shao
Associate, Beijing
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