LSHC Horizons Brochure 2024 - Flipbook - Page 63
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | APAC
63
China’s continuous efforts in improving the fast-track routes
for drug marketing authorization
Recently, China’s National Medical Products
Administration (NMPA) and Center for Drug
Evaluation (CDE) have issued several policies
on the optimization of review and approval of
drug marketing authorization, including, for
example, the Opinions on Reforming Review
and Approval Process for Drugs and Medical
Devices and the Announcement for Adjusting
the Review and Approval of Drug Clinical
Trials. The release of these optimization
policies aims to further improve the procedures
of four fast-track routes available in China,
namely, (1) Breakthrough Therapy Designation
(BTD), (2) the conditional approval procedure,
(3) the priority review procedure, and (4)
the special review procedure for the drug
marketing authorization established by the
PRC Drug Administration Law and the
Measures for the Administration of Drug
Registration since 2020.
Lu Zhou
Partner
Beijing
On 31 March 2023, the CDE issued the Work
Specification for Accelerating the Review of
Innovative Drug Marketing Authorization
Applications (Trial) with immediate effect
on the same day. This work specification is
designed to expedite the review workflow
of innovative drug marketing applications
through early involvement, research and
review coupling, rolling submission, and
prior inspection. On 25 August 2023, the
NMPA released the revised draft of Review
and Approval Procedures for Conditional
Approval of Drug Marketing Applications
(for Trial Implementation) for public
comments. This draft revised version provides
certain definite responses to the opening issues
regarding the drug conditional approval, which
have not been addressed in the existing version
issued by the NMPA in 2020.
The release of these new rules implies a
significant acceleration in the progress toward
the approval of drugs for pediatrics, rare
diseases, and those granted BTD.
Roy Zou
Partner
Beijing
Jessie Xie
Counsel
Beijing
Carol Shao
Associate
Beijing
