Life Sciences Horizons Brochure 2025 - Flipbook - Page 78
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2025 Horizons Life Sciences and Health Care
China issues new rules on domestic responsible persons
On 13 November 2024, China’s National Medical
Products Administration (NMPA) issued the
“Management of Domestic Responsible Persons
Designated by Overseas Drug Marketing
Authorization Holders Interim Provisions” (the “Interim
Provisions”), which will come into effect on 1 July 2025.
The Interim Provisions are designed to enhance
regulatory oversight of overseas marketing
authorization holders (MAHs) and their designated
domestic agents, ensuring accountability across
the life cycle of imported drugs.
A domestic responsible person (DRP) is a legal entity registered in
China required to be designated by the overseas MAH to assume
joint responsibility for performing drug marketing authorization
obligations within China. Broadly speaking, the DRP shares
responsibility with the MAH for ensuring compliance with local
laws, regulations, and rules in China.
To qualify as a DRP, an entity must:
Be a Chinese-registered legal entity;
Have in place a quality management system aligned with the
MAH’s obligations;
The DRP will be responsible for performing several key
obligations, including:
Ensuring drug quality and safety and establishing postmarket
quality assurance systems;
Implementing traceability systems and submitting annual
reports on sales, postmarket research, and risk management;
Managing drug registration changes, renewals, and recalls;
and,
Monitoring adverse drug reactions and coordinating with
NMPA for inspection and enforcement.
Starting from 1 July 2025, the DRP’s name, address, and contact
details, must be included in the drug’s packaging insert. This
means that DRPs are likely to have a much more consumer-facing
role than previously.
The Interim Provisions underscore China’s growing commitment
to ensuring the safety and regulatory compliance of imported
drugs. Overseas MAHs must carefully assess their compliance
strategies and designate a qualified DRP in China that can meet
these new requirements. For MAHs that already have DPRs, they
should audit their existing stable and verify their compliance with
the new criteria. This may result in a shake-out of current DPRs.
The incumbent DPRs may also seek different commercial terms
based on the costs of complying with the new requirements.
Maintain dedicated personnel for drug quality oversight; and
Have suitable office facilities;
Failure to meet these conditions will result in the suspension
of the sale or import of the overseas drug, with provincial-level
NMPA responsible for enforcing these compliance requirements.
The DRP must be designated prior to importation of the drug into
China. Each drug can only have one designated DRP in China,
although the same DRP may represent multiple overseas MAHs
or drug products.
Andrew McGinty
Partner
Hong Kong
Wensheng Ren
Counsel
Hogan Lovells Fidelity
