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3 min read
China’s pharmaceutical market represents a critical growth opportunity for global drug manufacturers. However, entering this market comes with strict Regulatory requirements for registration of drugs in China under the National Medical Products Administration (NMPA).
Foreign companies without a physical office in China can still pursue China drug registration and maintain medicinal products, provided they appoint a Local Representative (LR) to fulfill legal and Regulatory obligations under the Marketing Authorization Holder (MAH) system.
Regulatory Basis
China’s drug registration and lifecycle management are governed by:
- Drug Administration Law of the People’s Republic of China (2019 Revision): establishes the MAH system
- Regulations for Implementation of the Drug Administration Law of the People's Republic of China (2024 Revision): Elaborate on the specific requirements
- Provision for Drug Registration (Order No. 27, effective July 2020): outlines registration categories, procedures, and documentation
- Provision for Pharmaceutical Production (Order No.47, effective July 2020)： describes the requirements for the production, release, and life cycle management of drugs
- Good Manufacturing Practice (Revision 2020, effective Mar 2011): standardize the quality control of pharmaceutical manufacturing
- Good Pharmacovigilance Practice (Order No.65, effective Dec 2021): governs post-marketing drug safety monitoring
Drug Registration Process for Foreign Companies
It’s recommended to authorize a Local Representative (LR) to interact with NMPA for foreign pharmaceutical companies to facilitate the understanding and interpretation of regulatory requirements for registration of drugs in China.
For China drug approval, it’s required to appoint an LR to proceed with the application and communication on behalf of foreign companies/MAHs.
The drug approval process in China typically involves:
- Determine Registration Category: Imported Innovative Drug, Generic Drug, Biologic, or Traditional Medicine
- Compile the CTD Dossier: covering quality, non-clinical, clinical, and pharmacovigilance documentation (ICH CTD format)
- Clinical Trial & Bridging Studies: local clinical data may be required depending on product type, aligned with China clinical trial regulations
- Submit Application via LR: LR manages all interactions with the NMPA, including dossier submission, supplementary data requests, and inspection coordination
Obligations of the Local Representative (LR) fulfilled with MAHs together
Under the MAH system, the LR is legally responsible for the product in China. Key responsibilities include:
- Post-approval quality assurance system to ensure the capability of drug quality assurance and risk control
- Drug traceability
- Annual report
- Post-marketing change management and license renewal
- Pharmacovigilance and adverse reaction report
- Management of recall and complaint
- Offer reference standard substance to NIFDC and support sampling test and batch release
- Liaison with MAH for on-site inspection and violation investigation
For China clinical trial approval process and registration activities, the LR’s role may include:
- Acting as the legal communication channel with NMPA
- Submitting registration dossiers, variations, and renewals
- Supporting on-site GMP inspections and responding to authority queries
- Coordinate the QC test for drug registration
- Ensuring compliance with labeling, package inserts, and Chinese translations
- Establishing a pharmacovigilance system, including reporting Serious Adverse Events (SAEs) to the NMPA
- Maintaining import drug licenses and coordinating with customs
Post-Approval Maintenance
Lifecycle management obligations are as strict as initial China drug approval
process:
- Renewal of Market Authorization: Required every 5 years under Order 27
- Post-Approval Variations: Manufacturing site, process, formulation, or labeling changes etc
- Pharmacovigilance & Risk Management: MAHs (via LR) must maintain a PV system, submit Periodic Safety Update Reports (PSURs), and implement risk minimization measures
- Annual Reporting: Certain product categories require periodic reports on safety and sales
- Import Management: LR handles import license renewals, batch testing, and customs clearance
Selecting the Right Local Representative
Since the LR assumes Regulatory accountability on behalf of the foreign MAH, choosing the right partner is crucial. Consider:
- Regulatory Expertise: Proven experience in NMPA drug registrations
- Pharmacovigilance Capability: Systems to manage safety monitoring per GVP requirements
- Lifecycle Management Capacity: Handling variations, renewals, and compliance reporting
- Reputation & Reliability: Trusted partner to safeguard your product in China
Conclusion
Foreign pharmaceutical companies do not need a physical office in China to complete the drug approval process in China or maintain their medicinal products. By leveraging the MAH system and appointing a qualified Local Representative, companies can comply with NMPA regulations, manage product lifecycle obligations, and secure access to one of the world’s most lucrative healthcare markets.
Simplify Compliance – Partner with Experts to Navigate China’s Regulatory Pathway.
