Cambodia

Medicines regulation in Cambodia is overseen by the Department of Drugs and Food (DDF), Ministry of Health. Cambodia has a national pharmacovigilance system and a Cambodian Pharmacovigilance Centre; the published Guideline for Adverse Drug Reaction Monitoring and Related Matters describes roles for registration holders, medical institutions, healthcare professionals and consumers in ADR monitoring. Current DDF registration services are available through CamPORS. The current accessible official/public-authority materials do not establish an EU-style local QPPV or PSMF requirement, or a universal PSUR/RMP submission schedule for every MAH, so those obligations are not established without a current DDF provision. Registration holders should follow the Cambodian ADR-monitoring requirements and any product-specific post-marketing conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.