Pharmacovigilance Services in Chile

Entering or operating in Chile’s regulated pharmaceutical market requires reliable pharmacovigilance execution aligned with national safety expectations set by the Instituto de Salud Pública (ISP) under the Ministry of Health (MoH).

DDReg provides Pharmacovigilance Services in Chile for pharmaceutical, biotech, and life sciences companies seeking compliant, inspection-ready drug safety operations. We act as your local pharmacovigilance contact in Chile, delivering operational PV support, authority-aligned reporting, and scalable drug safety outsourcing Chile solutions without over-engineering or regulatory gaps.

As per the latest available regulatory guidance, Chilean regulations do not explicitly mandate the appointment of a QPPV, LQPPV, or LCPPV equivalent to EU requirements.

• A clearly designated local pharmacovigilance contact in Chile
• Defined responsibility for safety monitoring and reporting
• Reliable availability for authority communication and follow-ups

In practice, MAHs operating in Chile must ensure local accountability for pharmacovigilance activities, even in the absence of a formally named QPPV role.

DDReg provides Local QPPV Chile–equivalent oversight, including:

• Named local pharmacovigilance contact
• Authority-facing safety communication
• Oversight of PV activities conducted locally or via outsourcing partners

This approach ensures compliance while remaining aligned with Chile’s regulatory structure.

• Sanitary Code (Decree with Force of Law No. 725/1967)

  Establishes the legal foundation for health product regulation and safety surveillance in Chile.

• Supreme Decree No. 3/2010

  Regulates pharmaceutical products, including post-marketing obligations related to safety monitoring.

• Supreme Decree No. 825/1999

  Defines regulatory controls applicable to medicinal products and health oversight.

• ISP Technical Guidelines and Ancillary Regulations

  Provide operational guidance on adverse event reporting, safety documentation, and authority expectations.

• + Individual Case Safety Report (ICSR) Management
  • End-to-end case intake, medical review, and quality control
  • Management of serious and non-serious adverse events
  • MedDRA coding and compliant safety narratives
  • ISP Chile pharmacovigilance reporting aligned with national timelines
  • VigiFlow reporting services Chile for structured safety submissions
• + Aggregate Safety & Periodic Reporting
  • Preparation and review of periodic and aggregate safety reports
  • Alignment of Chile safety data with global safety systems
  • Scientifically sound benefit–risk assessments
  • Audit-ready documentation supporting ISP review
• + Signal Detection & Risk Management
  • Ongoing signal detection and trend analysis
  • Local safety impact assessment for Chilean patient populations
  • Support for risk minimisation and safety communication strategies
  • Lifecycle safety oversight across marketed products
• + PV System Setup, Maintenance & Audit Support
  • Design and maintenance of Chile-aligned pharmacovigilance systems
  • SOP development and safety governance documentation
  • Gap analysis and ISP inspection preparedness
  • Scalable pharmacovigilance outsourcing Chile models for MAHs
• + Local Pharmacovigilance Contact & Safety Oversight
  • Provision of local pharmacovigilance contact Chile
  • LCPPV services Chile–equivalent oversight, where operationally required
  • Authority communication and safety query management
  • Continuous safety supervision for locally marketed products
• + Drug Safety & Pharmacovigilance Outsourcing
  • Flexible drug safety outsourcing Chile solutions
  • Operational PV execution with retained MAH oversight
  • Seamless integration with global pharmacovigilance systems
  • Reliable safety data management for regional and global portfolios

Why Choose DDReg as Your Pharmacovigilance Partner in Chile

• Proven expertise in ANAMED pharmacovigilance services–aligned execution
• Strong experience with ISP Chile pharmacovigilance reporting processes
• Practical, inspection-ready pharmacovigilance delivery
• Trusted pharmacovigilance outsourcing Chile partner for global MAHs
• Execution-driven support from a dedicated pharmacovigilance service provider Chile