Myanmar

The primary regulatory authority for health products in Myanmar is the Food and Drug Administration (FDA Myanmar), operating under the Ministry of Health. The principal governing legislation is the Food and Drug Law (2018), which consolidated and modernized earlier frameworks to establish a more comprehensive system for the registration, licensing, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for sale or distribution in Myanmar must undergo product registration with FDA Myanmar before they may be legally marketed. The general approval process involves submission of a product dossier, laboratory testing where applicable, facility inspection for manufacturers, and review by the relevant technical committee before a registration certificate is issued.

Submission dossiers are generally expected to follow the ASEAN Common Technical Dossier (ACTD) format, reflecting Myanmar's membership in the ASEAN harmonization framework, although full alignment with ASEAN harmonized guidelines remains a work in progress. A locally registered company or authorized in-country representative is required to act as the applicant for foreign manufacturers, and a valid Certificate of Pharmaceutical Product (CPP) or equivalent certificate of free sale from the country of origin is typically mandated. Recent reform efforts have focused on digitizing the registration system, introducing risk-based classification for medical devices, and aligning post-market surveillance obligations more closely with international standards. The political and administrative disruptions following the February 2021 military takeover have significantly affected regulatory capacity and processing timelines, creating considerable uncertainty for market authorization applicants.

Public procurement of health products in Myanmar is primarily managed through the Ministry of Health, with central procurement processes historically coordinated by the Central Medical Store Depot (CMSD), which handles warehousing and distribution of medicines, medical supplies, and equipment to public health facilities across the country. National-level tenders are conducted by the ministry's procurement units in accordance with the Union Government's procurement rules, with budget allocations determined through the national health budget cycle. Sub-national procurement occurs at the state and region level, though the degree of decentralization has varied considerably, and the post-2021 environment has further fragmented public health system financing and supply chain operations.

The private sector constitutes a substantial and growing share of health product consumption in Myanmar, with distribution channeled through licensed importers, wholesale distributors, and retail pharmacies concentrated particularly in Yangon and Mandalay. Donor-funded procurement represents a critical parallel channel, especially for essential medicines, diagnostics, and health commodities related to HIV, tuberculosis, and malaria programs. Key international partners historically active in Myanmar have included the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF, the World Health Organization, USAID, and the Three Millennium Development Goal Fund successor programs. Since 2021, many bilateral and multilateral donors have redirected funding away from government channels toward non-governmental and civil society organizations, significantly reshaping the procurement and distribution landscape. Local manufacturing preference policies exist in principle but the domestic pharmaceutical manufacturing sector remains limited in scale and capacity.