2021 LS&HC Horizons - Flipbook - Page 52
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Hogan Lovells
China’s further improved fast-track review regime for drugs
Prior to the promulgation of new Drug
Administration Law (DAL) in 2019, the National
Medical Products Administration (NMPA) has
launched several expedited approval programs
for marketing of innovative drugs in China in
several scattered rules and notices, like the
Opinions on Encouraging Drug Innovation and
Implementing Priority Review and Approval
issued earlier in 2017. The amended Measures on
the Administration of Drug Registration released
on 22 January 2020 to implement the new DAL
formally adopts four procedural programs to
accelerate the review and approval of certain
categories of drug marketing applications based
on, among other things, the clinical need for the
drugs and the severity or rare nature of the illness
that the drugs can treat, including:
• the breakthrough therapy program,
which enables the applicant for the
registration of innovative drugs for serious
or life-threatening conditions to request
communication with the Center for Drug
Evaluation (CDE) at the clinical trial stage
and to receive comments and guidance from
the CDE reviewers on the applicant’s clinical
trial strategy and clinical data requirements;
• the conditional approval program, under
which the drugs that treat severity or rare
nature of the illness can be conditionally
approved but the NMPA will place
post-marketing conditions on drugs and
a timeline for completion after
conditional approval;
• the priority review and approval program,
under which the drugs eligible for this
program, including for example those
have received a breakthrough therapy
designation or conditional approval
designation or these are urgently needed,
will be granted with expedited review
timeframe; and
• the special approval program, under which
the drugs needed in responding to the
public health emergency will be reviewed,
inspected and examined by the NMPA in a
unified and accelerated manner.
On 7 July 2020, the NMPA issued the working
procedures on breakthrough therapy program,
conditional approval program, and priority
review and approval program. The working
procedures provide pragmatic guidance for the
application of the expedited approval programs
by specifying the qualified drugs eligible to apply
for the programs, how the applicants initiate the
program as well as the review process conducted
by the CDE.
Roy Zou
Office Managing Partner, Beijing
roy.zou@hoganlovells.com
Lu Zhou
Partner, Beijing
lu.zhou@hoganlovells.com
Jessie Xie
Senior Associate, Beijing
jessie.xie@hoganlovells.com
