PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for China’s Globalized Pharma Market: NMPA | GVP | DDRP | ICH
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for China’s rapidly evolving pharmaceutical landscape.
China is the world's second-largest pharmaceutical market, transitioning from a generic-centric model to a global innovation hub. As of 2025, the NMPA is enforcing stricter alignment with ICH standards while introducing uniquely Chinese accountability measures. With the Interim Provisions on Designated Domestic Responsible Persons (DDRP) taking full effect in July 2025, overseas Marketing Authorization Holders (MAHs) must now integrate their global safety data with a legally recognized in-country representative. Since 2008, we have supported firms in Beijing, Shanghai, and Suzhou in delivering high-quality safety dossiers that meet the rigorous scientific expectations of the CDE (Center for Drug Evaluation).
Who We Support in China
We provide specialized pharmacovigilance expertise across the Chinese "Life Science Innovation" clusters:
Multinational Pharma (MNCs): Helping overseas MAHs bridge the gap between global PBRERs and specific NMPA-format PSUR requirements, ensuring data consistency across regions.
Chinese "Go-Global" Leaders: Assisting domestic firms in Zhangjiang High-Tech Park and Suzhou BioBay in drafting ICH-compliant reports for their first FDA and EMA submissions.
Designated Domestic Responsible Persons (DDRP): Providing the technical pharmacovigilance "engine" for local legal representatives who are held accountable for real-time safety monitoring under the 2025 regulations.
Innovative Biotech & CAR-T Developers: Supporting firms with the latest September 2025 CDE draft guidelines for cell and gene therapy safety reporting and DSUR management.
Clinical Trial Sponsors: Managing Development Safety Update Reports (DSURs) for multi-regional clinical trials (MRCTs) conducted in China.
Our PSUR & PBRER Services
Our scientific precision matches the NMPA’s shift toward a "Lifecycle Pharmacovigilance" model:
NMPA-Compliant PSUR/PBRER Drafting: Professional preparation in Mandarin Chinese and English, following China GVP (2021) and ICH E2C (R2) standards.
2025 DDRP Support Framework: Specialized workflows to facilitate the legal accountability of your Chinese representative, ensuring timely submission of safety updates.
Annual Reporting for Innovative Drugs: Ensuring "Class 1" innovative drugs meet the mandatory annual reporting cycle for the first five years post-approval.
Signal Detection for the Chinese Population: Utilizing scientific methodologies to validate and assess safety signals specifically for Chinese patients, incorporating data from the National ADR Monitoring System.
Mandatory Literature Screening: Comprehensive searches of both international (PubMed/Embase) and local Chinese medical databases (CNKI, Wanfang) as required by GVP.
Why Pharma Leaders in China Choose PSUR Central
"Scientific rigor for the world's fastest-evolving pharmaceutical regulatory environment."
July 2025 Readiness: We are fully operational under the new DDRP Interim Provisions, ensuring that your local representative has the technical data needed to meet NMPA mandates.
Mandarin Language Excellence: All reports are prepared with precise technical Mandarin, avoiding the translation pitfalls that frequently lead to CDE queries.
Hybrid Compliance: We specialize in "localized PBRERs"—taking your global safety data and enriching it with the China-specific analysis required for NMPA re-registration.
Audit-Ready Documentation: Our reports have a proven track record of passing NMPA and provincial-level GVP inspections.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Drug Administration Law (2019 Revision): The legal foundation of China's PV system.
China Good Pharmacovigilance Practice (GVP 2021): The "Gold Standard" for MAH safety obligations.
NMPA Announcement No. 96 (2025): Regarding the importation of commercial-scale batches and risk management.
CDE 2025 Draft Guidelines: Including the latest FAQ on DSUR reporting and advanced therapy safety monitoring.
Get Started: Partner With Us
To initiate a customized project for your China-based operations, we typically require:
Product Classification: (e.g., Innovative Drug, Modified New Drug, or Generic).
DDRP Details: Contact information for your designated domestic responsible person.
Approved Labeling: The Chinese SmPC (Instruction Manual) and Reference Safety Information (RSI).
Local vs. Global Data: Summary of ADRs from the Chinese market and your global safety database.
Submission Timeline: Coordination with your China Data Lock Point (DLP) or re-registration schedule.
Contact PSUR Central today to ensure your NMPA safety compliance is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.