Cambodia

The primary regulatory authority for health products in Cambodia is the Department of Drugs and Food (DDF) under the Ministry of Health (MoH). The DDF oversees the registration, licensing, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. The principal governing legislation includes the Law on the Management of Pharmaceuticals (2013) and associated sub-decrees and prakas (ministerial regulations) that set out the framework for product registration, import licensing, and distribution controls. All health products must undergo a formal registration process administered by the DDF before they can be legally marketed or distributed in Cambodia, with applicants required to submit product dossiers for technical and safety review by the DDF's expert committees.

Submission requirements under the DDF mandate that foreign manufacturers appoint a locally registered importer or authorized representative who is licensed by the MoH and assumes regulatory responsibility within Cambodia. Dossiers are generally expected to conform to the ASEAN Common Technical Dossier (ACTD) format, in alignment with Cambodia's membership in the ASEAN Pharmaceutical Product Working Group, though full ICH CTD submissions are also accepted. Supporting documentation typically includes certificates of pharmaceutical product (CPP) from the country of manufacture, Good Manufacturing Practice (GMP) certificates, clinical and pre-clinical data, labeling in Khmer, and product stability data. Cambodia has been progressively aligning its regulatory framework with ASEAN harmonization initiatives, and the DDF has undertaken capacity-building reforms to streamline review processes, reduce registration backlogs, and improve post-market surveillance, though implementation remains uneven and timelines can extend significantly in practice.

Public procurement of health products in Cambodia is primarily managed through the Ministry of Health, with the MoH's Department of Planning and Health Information and the Central Medical Stores (CMS) playing key roles in demand forecasting, tendering, and distribution of medicines, diagnostics, and medical supplies to public health facilities. National-level procurement follows the Law on Public Procurement and associated regulations overseen by the Ministry of Economy and Finance, with international competitive bidding required above defined thresholds. The National Committee for Health Products Management coordinates policy across relevant departments, and the CMS serves as the central warehousing and distribution hub for publicly procured health commodities delivered to provincial health departments and public hospitals.

Cambodia's public health system remains substantially dependent on donor-funded procurement channels, with major global health partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, UNICEF, Gavi the Vaccine Alliance, and the World Health Organization collectively financing a significant share of essential medicines, vaccines, diagnostics, and health commodities. These agencies often procure through their own international mechanisms such as UNICEF Supply Division or USAID's Supply Chain Management System, sometimes bypassing national tender processes, though alignment with national health plans is encouraged. The private sector market is served by licensed importers and distributors supplying private clinics, pharmacies, and NGO-operated facilities. Local manufacturing capacity is very limited, and Cambodia does not currently apply strong formal local manufacturing preference policies in procurement, though national health strategies express ambitions to develop domestic production capacity over time.