Myanmar

The Food and Drug Administration (FDA) of Myanmar, operating under the Ministry of Health, serves as the primary regulatory authority responsible for the registration, licensing, and post-market surveillance of health products including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. The principal governing legislation is the National Drug Law (1992) and its subsequent amendments, supplemented by the Food and Drug Administration Law (2018), which expanded the FDA's mandate and modernized its institutional framework. All health products must undergo a formal product registration process before they can be legally marketed or imported into Myanmar, and foreign manufacturers are generally required to appoint a locally registered importer or authorized agent to submit and manage registration dossiers on their behalf.

Submission dossiers are broadly expected to follow the ASEAN Common Technical Dossier (ACTD) format, reflecting Myanmar's position as an ASEAN member state and its gradual alignment with regional harmonization efforts under the ASEAN Pharmaceutical Product Working Group (PPWG). Key submission requirements include certificates of pharmaceutical product (CPP) from the country of origin, Good Manufacturing Practice (GMP) certification, and evidence of product registration or approval in a recognized reference country. The FDA has pursued incremental reforms in recent years, including the introduction of electronic submission pathways and expedited review tracks for essential medicines and products addressing unmet public health needs, though implementation capacity remains variable and timelines can extend significantly due to administrative backlogs and resource constraints.

Public sector procurement in Myanmar is centralized primarily through the Ministry of Health, with the Central Medical Stores Depot (CMSD) serving as the main warehousing and distribution entity for government-procured health commodities. National-level procurement is conducted through formal tendering processes governed by public procurement rules, with the Ministry of Planning and Finance providing overarching regulatory oversight for government spending. Budget allocation and procurement planning occur at the union (federal) level, though state and region health departments may conduct supplementary local procurement for facility-level needs. The procurement landscape has been substantially disrupted since the military takeover in February 2021, leading to reduced government health expenditure, fragmented supply chains, and increased reliance on non-governmental and international channels to maintain health commodity availability.

The private sector plays a significant and growing role in health product distribution in Myanmar, with a large network of private pharmacies, clinics, and hospitals sourcing products through licensed importers and distributors. International donor and multilateral agencies, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF, the World Health Organization (WHO), and USAID-supported programs, have historically provided substantial volumes of health commodities outside the government procurement system, particularly for HIV, tuberculosis, and malaria programs. Gavi, the Vaccine Alliance, has also supported immunization supply chain activities. Given the political and humanitarian situation post-2021, donor-funded parallel procurement channels have become especially critical for ensuring continuity of essential health product supply. Local manufacturing capacity remains limited, and while there is an expressed policy preference for domestically produced goods where feasible, the majority of health products, including medicines, diagnostics, and medical devices, continue to be imported.