LS&HC Horizons 2023 - Flipbook - Page 54
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | APAC
Strengthened emphasis on drug and medical device
quality management in China
In 2022, the People’s Republic of China (PRC)
National Medical Products Administration
(NMPA) released several pieces of regulations
and drafting rules which put further
emphasis on the establishment of effective
quality management systems (QMS) for
various aspects in the lifecycles of drugs
and medical devices. Compared with the
existing QMS requirements, these regulations
and drafting rules provide further detailed
updates and requirements in fields including,
but not limited to, the institution and
personnel, factory, facilities and equipment,
documentation management, and the design
and development process of different types
of drugs/medical devices.
drug/medical device-related activities of
clinical trials, manufacturing, and distribution
are also required to establish their quality
management systems.
These QMS related regulations and drafting
rules shed light on the NMPA's regulatory
focus in the near future. It may place a higher
demand on MAHs to further supervise their
cooperative partners and third party vendors
for compliance with their QMS. Accordingly,
drug and medical device companies should
prioritize monitoring the regulatory progress
and preparing for updated QMS requirements.
Furthermore, in addition to the market
authorization holder (MAH) of the drugs
and medical devices who take the ultimate
responsibility of the product QMS, all other
parties, such as medical institutions, contract
manufacturers, distributors, and third-party
logistics service providers participating in
Lu Zhou
Partner, Beijing
Carol Shao
Associate, Beijing
Jessie Xie
Counsel, Beijing
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