Quote from VigiServe Admin on November 27, 2020, 1:55 PM

In Cambodia, the pharmacovigilance system is managed by the Department of Drugs and Food (DDF) under the Ministry of Health, specifically through the Cambodian Pharmacovigilance Center. The system is WHO-aligned and evolving through ASEAN harmonization efforts.

1. Clinical Safety (Clinical Trials)

Clinical trials require DDF authorization and adherence to ICH GCP standards.

• Expedited Reporting: Sponsors are expected to report SUSARs (Suspected Unexpected Serious Adverse Reactions). While not rigidly codified in national law, practice aligns with international norms:

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are typically required annually.

• Submission: Direct submission to the DDF/PV Center via forms or email.

2. Post-Marketing Pharmacovigilance

• Personnel & Infrastructure:

  • Local Responsible Person: Mandatory. Marketing Authorization Holders must have a qualified person responsible for pharmacovigilance permanently available in Cambodia.

  • PSMF: Not explicitly required to be registered or maintained locally in public guidelines.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous reporting is prioritized.

  • Timelines: Not rigidly codified; "Prompt" reporting is expected for serious/unexpected cases (aligned with WHO expectations).

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory; may be requested during renewals or variations.

  • RMPs: Not a standard mandatory requirement; handled reactively.

Summary of Requirements

Component	Requirement in Cambodia
Regulatory Authority	DDF (Department of Drugs and Food)
Framework	ADR Guidelines / WHO
Local QPPV / PSMF	Yes (Local Resp.) / No
Safety Reporting	Prompt (Serious) / -
Clinical Reporting	SUSARs (7/15 days - ICH Align)
Submission Language	English / Khmer