Pharmacovigilance Services in China

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in China, access to pharmacovigilance services in China is critical to ensuring drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with NMPA China pharmacovigilance guidelines, the right local pharmacovigilance partner in China shapes everything: signal detection, risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the China Market

China ranks as the world’s second-largest pharmaceutical market, and its pharmacovigilance system has evolved significantly in recent years. With the introduction of Good Pharmacovigilance Practices (GVP) in December 2021, the National Medical Products Administration (NMPA) has standardized the responsibilities of Marketing Authorization Holders (MAHs) and clinical trial sponsors. These requirements mandate comprehensive drug safety evaluations, robust reporting systems, and continuous monitoring to reduce risks and safeguard patient health. Uniquely, China’s regulatory framework extends beyond pharmaceuticals to include traditional Chinese medicine (TCM), ethnomedicine, medical devices, and cosmetics, making expert guidance vital for navigating the local drug registration and approval process.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases integrated with WHO DD and MedDRA
  • Quality checks and medical reviews
  • Timely submission of cases per NMPA timelines
  • Ongoing ICSR monitoring and reconciliation with partners
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS per China GVP requirements
  • Customized classification of safety risks with tailored mitigation strategies
  • Risk assessment reports addressing missing information and potential safety concerns
  • Implementation of supplementary measures (PASS, observational studies, targeted questionnaires)
  • Risk communication via SmPCs and Patient Information Leaflets (PILs)
• + Aggregate Reports
  • Periodic Benefit-Risk Evaluation Reports ( PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals from ICSR databases, literature, aggregate reports, and NMPA monitoring
  • Use of in-house databases for signal detection and tracking
  • Review of safety signals and PRAC-style recommendations
  • Label update analysis and risk minimization recommendations
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + PV Services, RPPV Functions
  • Provision of RPPV (Responsible Person for Pharmacovigilance in China) services as mandated by NMPA, ensuring local oversight, compliance, and authority communication
  • Review of PSMF, SDEA agreements, partner contracts, and PV SOPs
  • Sign-off of aggregate reports, signal reports, and RMPs
  • Retainer services for ongoing pharmacovigilance governance
  • Monthly reconciliation and compliance metrics reports
  • Signal detection surveillance meetings and quarterly reviews
  • Oversight of PV Quality Management Systems
• + PV Audit & Compliance
  • Audits aligned with NMPA China pharmacovigilance guidelines
  • Regular gap assessments for PV staff
  • Tailored audit plans and mock inspections to prepare for NMPA audits
  • PV training programs for inspection readiness and compliance culture