Pharmacovigilance Aggregate Reporting in China

China’s pharmacovigilance system is governed by several regulations:

• Drug Administration Law (2019, No. 31)²: Establishes the legal framework for drug safety monitoring and reporting.
• Good Pharmacovigilance Practices (GVP) (2021, Decree No. 65)³: Provides comprehensive guidance for safety monitoring throughout a drug’s lifecycle.
• Chinese Pharmacopoeia 2025 Edition (effective 01 October 2025)⁴: Reflects updated safety and quality standards for pharmaceuticals.
• ICH Guideline Adoption (2017)⁵: China has adopted ICH E2A, E2B, E2D, and E2E guidelines.6 Thus, its reporting standards align with global norms.
• CDE’s Technical Guidance on Electronic Common Technical Document (eCTD) Submissions (2025, No. 10)⁷: Provides formatting and submission protocols for electronic safety reports.

When Required

DSURs are mandatory for investigational drugs under clinical development in China. This aggregate safety report must be submitted annually following the initial clinical trial approval. DSURs provide a comprehensive overview of a drug’s safety profile, integrating data from all ongoing studies. This helps regulators and sponsors identify emerging risks early in the development process.

Key Components

• Cumulative safety data from all clinical trials
• Summary of significant findings
• Risk-benefit analysis
• Actions taken for safety concerns

China-Specific Notes

• Must follow ICH E2F⁶ format.
• Regional Chinese annexes are required in accordance with regional guidance.⁸
• Submitted annually to the CDE.
• The NMPA expects prompt reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) during clinical trials.⁹
• DSURs must be submitted in Chinese or a bilingual format.¹⁰

When Required

PSURs (also referred to as Periodic Benefit-Risk Evaluation Reports or PBRERs) are required for marketed drugs. This report is especially important during the first few years after drug approval or when new safety concerns arise. This aggregate safety report evaluates the marketed product’s evolving benefit risk balance at defined intervals in real world use.

Key Components

• Interval safety data
• Cumulative safety overview
• Benefit-risk evaluation
• Regulatory actions taken

China-Specific Notes

• PSURs must align with the ICH E2C(R2)⁶ format.
• Required for newly approved drugs and those with emerging safety concerns.
• Submission timelines and frequency may vary depending on the product’s risk profile and NMPA requirement.¹¹

When Required

RMPs are a cornerstone of premarketing and postmarketing safety strategy.^12,13 RMPs outline known and potential risks, propose mitigation measures, and define pharmacovigilance activities tailored to the product’s risk profile.

An RMP is required:

• At the time of new drug application (NDA) submission
• When significant safety concerns are identified
• For high-risk products (e.g., biologics, orphan drugs)
• This aggregate safety report identifies, characterizes, and minimizes risks associated with a drug throughout its lifecycle.

Key Components

• Safety specification
• Pharmacovigilance plan
• Risk minimization measures

China-Specific Notes

• Required at NDA submission and when significant safety issues arise.¹⁴
• RMPs must be tailored to the Chinese population and healthcare system.
• The NMPA may request updates to the RMP based on postmarketing data¹³ or international findings.

• Localize Content: Ensure all documents are adapted to Chinese regulatory expectations and language.
• Engage Local Experts: Collaborate with local pharmacovigilance professionals, including Certara, familiar with NMPA processes.
• Stay Updated: Monitor updates from the NMPA and CDE, as well as the National Center for Adverse Drug Reaction Monitoring (NCADRM), for evolving requirements and latest insights.
• Use eCTD Format: Align with CDE’s 2025 guidance for electronic submissions in parallel with the ICH formats while incorporating China specific sections.
• Maintain Consistency: Ensure alignment across DSUR, PSUR, and RMP documents.

With China’s pharmacovigilance guidelines maturing rapidly, pharmaceutical companies must be proactive in preparing high-quality, compliant aggregate safety reports. By aligning with international standards, while understanding the regulatory nuances and integrating global best practices with local requirements, Certara’s pharmacovigilance medical writers can help companies ensure both compliance and patient safety. Complying with these evolving requirements is a regulatory obligation and a strategic imperative in one of the world’s most dynamic pharmaceutical markets.

The author would like to thank the entire Certara pharmacovigilance writing team for their support in writing this blog.