LSHC Horizons Brochure 2024 - Flipbook - Page 64
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | APAC
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China’s regulatory pathways for cell therapy products
The development of cell therapy products has
been a recent hot topic in China’s life sciences
industry. Generally, clinical research on
cell therapies that do not aim for marketing
authorization is regulated by the National
Health Commission (NHC), while clinical
trials of cell therapy products for the purpose
of obtaining marketing authorization are
regulated by the National Medical Products
Administration (NMPA), following the
application procedures for drugs.
In terms of clinical research, Chinese
authorities released the Administration
Measures for Stem Cell Clinical Research
(Trial) in 2015, stipulating requirements on
the clinical research institutions qualified for
conducting clinical research, the application,
review, and filing procedures for such projects,
and certain other requirements during the
clinical research process. Although this
regulation is not applicable to stem cell clinical
trials, it allows the submission of the clinical
research results for supporting materials in
applying for drug clinical trials aiming for
product marketing authorization. In May
Lu Zhou
Partner
Beijing
2023, the NHC released a draft Working
Guidelines for Somatic Cell Clinical Research
(Trial) (Working Guidelines) for public
comments and later authorized the China
Medicinal Biotech Association to issue the final
and official version. Similarly, the Working
Guidelines specify detailed requirements as to
the constitutional and technical requirements
to conduct somatic cell clinical research, and
documentation materials required for prefiling. In the application scope, the Working
Guidelines mentioned that “the somatic cell
clinical research administration cannot replace
drug clinical trial administration,” but it does
not seem to clearly exclude the possibility
that clinical research results can be used for
supporting product clinical trials for product
marketing authorization applications.
Certain cities, including Beijing, Shanghai,
and Shenzhen, have also released municipal
policies to incentivize the research and
development of cell and gene products, for
example, facilitating such products’ application
for marketing authorization.
Roy Zou
Partner
Beijing
Jessie Xie
Counsel
Beijing
Olivia Xie
Junior
Associate
Beijing
