China Issues New Domestic Responsible Person Rules for Foreign Drug Marketing Authorization Holders

China’s National Medical Products Administration (NMPA) on November 13, 2024 issued the Interim Provisions on the Administration of the Domestic Responsible Person Designated by Foreign Marketing Authorization Holders (New Regulation), which will become effective on July 1, 2025, along with NMPA’s official interpretation of the New Regulation (Interpretation).

The New Regulation integrates previously scattered provisions from various laws and regulations regarding the domestic responsible person (DRP), the designated local agent of a foreign holder of a drug marketing authorization (MAH) in China. It also provides more details on DRP-related responsibilities and requirements. This integration and refinement of DRP rules reflect the Chinese authorities' intention to strengthen compliance and accountability for both foreign MAHs and their DRPs. At the same time, it also signals a positive shift toward greater flexibility for foreign MAHs in appointing DRPs in China.

HIGHLIGHTS OF THE NEW REGULATION

DRP Shall Perform Substantive Responsibilities of the Foreign MAH and Undertake Joint and Several Liabilities with the Foreign MAH

The New Regulation reiterates the principle established under the 2019 revision of the Drug Administration Law: the DRP is deemed an extension of the foreign MAH in China, performing the regulatory obligations of the foreign MAH within China, and accordingly undertaking joint and several liabilities with the foreign MAH on the safety, effectiveness, and quality control of the approved imported drug. This role is substantive and distinct from that of a mere local agent, who may only handle specific regulatory procedures on behalf of the foreign MAH.

In particular, the New Regulation mandates that a foreign MAH must designate a DRP before the first importation and sale of its drug in China. The DRP’s information, such as name, address, and contact details, must be included in the drug instruction. This requirement underscores the DRP’s important role in regulatory compliance for imported drugs on the market in China.

While the New Regulation highlights the DRP’s primary role and duties in post-marketing compliance and lifecycle management, it suggests that a DRP is not necessarily to be involved in the pre-marketing stage. A foreign investigational new drug (IND) owner may engage separate domestic pre-marketing agents (e.g., a contract research organization) to assist tasks related to the drug development and regulatory procedural matters for the application of drug marketing authorization approval (MAA) in China. The Interpretation further affirms that the foreign MAH’s designation of a DRP will not affect pre-marketing regulatory approvals, such as IND filings or the MAA process for the product. This differentiation ensures imported drugs meet regulatory standards while allowing flexibility for foreign MAHs to engage specialized agents for pre-marketing regulatory tasks.

DRP Must Meet Required Qualifications, Including Appropriate Product-Specific Quality Management Systems

DRP should perform product-centric responsibilities jointly with the foreign MAH, including drug quality management, drug traceability, drug annual reports, post-marketing modifications or re-registration, pharmacovigilance, recalls and complaints, and cooperate with inspections by the NMPA including inspections on the overseas manufacturing site(s).

Given the importance of this role, a DRP shall meet the following qualifications:

• A Chinese corporate legal person: A DRP must be a duly registered corporate legal person in mainland China (excluding Hong Kong, Macau, and Taiwan), which means a representative office, branch office, or foreign MAH would not be qualified as its DRP
• Suitable quality management system: A DRP must establish a quality management system (QMS), have requisite personnel, facilities, and office premises, as well as dedicated personnel responsible for drug quality management activities
• These resources and systems must be adequate and suitable for the DRP to fulfill the responsibilities of a foreign MAH—in other words, they should align with the quality-related requirements for the imported drug under the DRP’s purview

This emphasis on QMS qualifications and related requirements under the New Regulation reaffirms the alignment between the DRP and the foreign MAH in terms of quality management and control, ensuring consistency based on the imported drug. This approach is more precise than the ambiguous requirement under the 2020 initial draft of the Interim Provisions on the Administration of the Domestic Agent Designated by the Foreign MAH (2020 Draft), which merely called for a QMS “adapted to its works” as a domestic agent of the foreign MAH. 

Furthermore, the New Regulation imposes significant consequences for noncompliance. Omission or violation of the requirements may result in administrative penalties up to suspension of the importation, use, and sale of the relevant drugs in China.

A Foreign MAH May Appoint Different DRPs for Different Products

The New Regulation retains the requirement that each drug must be assigned a designated DRP. However, it removes the requirement, previously proposed in the 2020 Draft, mandating that an MAH with multiple drugs must designate a sole DRP for all its products. If officially implemented, this change may allow foreign MAHs the flexibility to decide whether to assign the same DRP or different DRPs for their multiple drugs, based on product-specific needs, targeted product lifecycle management, cost-efficiency considerations, and other case-by-case factors.

This shift also reflects the authority’s intention to adopt a more product-centered approach to regulation and supervision while granting MAHs of multiple drugs greater discretion and operational flexibility.

Additionally, the New Regulation streamlines the process for foreign MAHs to change their DRP. They are now required to file the change with the NMPA within 15 business days of appointing a new DRP and to include the change in the drug’s annual report.

LOOKING AHEAD: RECOMMENDATIONS AND CONSIDERATIONS

We observe that specific guidance and practical implementation by the NMPA have not yet fully aligned with the New Regulation. In particular, the existing reporting platform may require upgrades to support functions related to the DRP, as outlined in the New Regulation. As the regulation was only recently issued and will not take effect until July 1, 2025, we anticipate updates and adjustments to the NMPA's regulatory frameworks and systems to align with the new requirements in practice.

In the meantime, we would recommend foreign pharmaceutical companies consider the strategic and operational measures below to prepare for the implementation of the New Regulation.

Enhanced Risk Management

The New Regulation underscores a strengthened regulatory framework for foreign MAHs and their DRPs, emphasizing the importance of selecting a DRP with robust compliance capabilities and expertise in navigating China’s regulatory landscape. A carefully chosen DRP can mitigate risks and ensure seamless regulatory compliance.

Operational Planning

While keeping a close eye on any further developments by China’s regulatory authority, Foreign MAHs may assess whether appointing different DRPs for different products is necessary, feasible, or to its interest by taking into consideration factors such as the real change of NMPA systems for different DRPs, product-specific needs, targeted product lifecycle management, cost-efficiency for multiple appointments, and potential confidentiality risks associated with managing multiple DRPs.

Proactive Transition Planning for New or Replacement DRPs

If a foreign MAH intends to appoint or replace a DRP, planning should begin during the transitional period before the New Regulation takes effect. This allows sufficient time to prepare or update the drug instructions, as the New Regulation requires the DRP’s details (e.g., name, address, and contact information) to be included in the drug instructions.

Adaptation to Post-Marketing Requirements

MAHs must ensure that their designated DRPs are equipped to handle critical responsibilities under the law, such as quality assurance, pharmacovigilance, and regulatory reporting. Failure to meet these requirements could result in disruptions to drug supply. Continuous supervision of the DRP’s compliance with applicable laws and regulations is essential to maintaining operational integrity.

By taking these proactive steps, foreign pharmaceutical companies can better navigate the transition to the New Regulation and ensure compliance with its requirements upon implementation.