On November 13, 2024, the National Medical Products Administration (NMPA) issued the "Interim Provisions for the Management of Domestic Responsible Persons Designated by Foreign Drug Marketing Authorization Holders," which will come into effect on July 1, 2025. The new regulations explicitly require foreign marketing authorization holders to designate local delegates[1] and authorize them to undertake important post-marketing responsibilities, including post-marketing change management, pharmacovigilance, and product quality complaint handling. For multinational pharmaceutical companies, establishing an effective management system is crucial: they must not only select professional and reliable local delegates, properly handle label and instruction updates, ensure compliance through contractual arrangements, and regulate cross-border data transfer, but also consider engaging professional legal teams as intermediaries to help establish long-term cooperation mechanisms between foreign holders and local delegates. This article will discuss these key issues and provide practical suggestions for companies.

I.Comprehensive Due Diligence 

Local delegates will undertake multiple important post-marketing responsibilities, and their professional capabilities and compliance levels directly impact the regulatory compliance of multinational pharmaceutical companies in the Chinese market. Given the July 1, 2025 implementation date, companies should start the selection process early. When evaluating potential candidates, professional capability is undoubtedly the core consideration. Companies need to carefully examine candidates' professional team composition, quality management system completeness, and past compliance records, particularly focusing on their experience and capability in handling post-marketing changes and pharmacovigilance.

A qualified local delegate must have comprehensive information systems, sufficient pharmacovigilance capabilities, and standardized document management systems. These infrastructures are crucial guarantees for effectively fulfilling their responsibilities. Meanwhile, candidates' overall strength also deserves attention. Good financial status ensures business continuity, while past commercial reputation and industry standing reflect their performance capability and professional standards. Companies are advised to collect relevant information through multiple channels and, when necessary, engage professional legal teams to assist with due diligence.

II. Robust Contractual Arrangements and Daily Management

Establishing sound contractual arrangements and management mechanisms is key to ensuring local delegates effectively fulfill their duties. Several core aspects need to be addressed in practice:

Contract design should be comprehensive and specific. Beyond basic delegation and authorization relationships, contract content needs to clearly stipulate specific requirements and standards for various responsibilities, including timelines for post-marketing changes, specific pharmacovigilance duties, and quality complaint handling procedures. It should also clearly define both parties' rights and obligations, as well as breach of contract responsibilities and dispute resolution mechanisms.

Collaboration mechanisms in daily operations also require careful design. Multinational pharmaceutical companies should establish regular communication channels with local delegates, hold regular work meetings, and handle various emergencies promptly. Particularly in cases of major safety information transmission and emergency recalls, both parties must maintain close coordination.

Companies can establish regular audit mechanisms to evaluate the work quality of local delegates. Key focus areas include whether they strictly follow regulations, complete statutory duties on time, and maintain complete and standardized documentation. Relevant personnel of local delegates should regularly participate in training to stay updated on the latest regulatory requirements and technical standards. Multinational pharmaceutical companies can provide necessary training support to ensure both parties maintain a consistent professional understanding.

III.Labeling and Instructions for Use (IFU) Updates

Timely updates of labels and instructions are crucial for drug safety. Under the domestic responsible person system, the management difficulty of this work will increase significantly. Multinational pharmaceutical companies need to establish a systematic management mechanism.

The timeliness and accuracy of information transmission is the primary challenge. When foreign headquarters need to update product labels or instructions, relevant information must be communicated to local delegates through standardized channels. This requires companies to establish standardized communication mechanisms, set clear time requirements, and ensure the entire process is traceable.

Internal review processes are equally important. After receiving update requirements, local delegates need to assess their applicability and compliance in the Chinese market. During this process, multinational pharmaceutical companies should establish scientific review procedures and provide necessary technical support to ensure updates meet both global standards and Chinese regulatory requirements.

Communication and filing with regulatory authorities also require careful planning. Different types of updates may involve different filing paths - some requiring approval before implementation, others following a filing system. Companies need to work with local delegates to establish clear operating procedures and specify processes for handling various changes.

The handling of urgent safety information requires special attention. When serious safety concerns require urgent label updates, rapid response mechanisms are essential. It is recommended to establish emergency plans in advance, clearly defining responsibilities and time requirements to ensure an efficient response in emergency situations.

IV. Cross-border Data Transfer

In fulfilling the duties of local delegates, cross-border data transfer is inevitable. This data may include pharmacovigilance data, adverse reaction reports, quality complaint information, and post-marketing research data. Companies need to pay special attention to several aspects:

Data classification is the primary task. Companies need to analyze potential data flows with local delegates, clearly identifying which constitute important data, which involve personal information, and which are general business data. Different types of data require different compliance measures. For the cross-border transfer of important data and personal information, strict compliance with the Data Security Law and Personal Information Protection Law is required, with security assessments conducted when necessary. Medical and health data, in particular, require especially careful handling.

Technical safeguards must be stringent. During data transfer, encryption, access control, and other technical measures must be implemented to ensure data security. Data traceability mechanisms should also be established to ensure the entire data flow process is trackable and controllable. Data processing provisions should be clearly specified in agreements, including data usage scope, confidentiality obligations, and security measures, to ensure compliant and controlled cross-border data transfer.

V.Professional Legal Support

In practice, engaging professional legal teams provides foreign companies with updates on the latest regulations and policy interpretations, while assisting foreign marketing authorization holders in compliance management and effective communication with local delegates, promptly alerting and fixing potential issues.

[Note] 

[1] A Local Delegate refers to a Domestic Responsible Person (DRP) designated by a foreign drug Marketing Authorization Holder (MAH) to fulfill statutory obligations in China. This entity must be a legal entity registered within Chinese mainland and possess the necessary capabilities to undertake post-marketing responsibilities including pharmacovigilance, quality management, product labeling updates, and regulatory compliance. The Local Delegate serves as the MAH's authorized representative and bears legal responsibility for the product's ongoing compliance with Chinese regulations.