Myanmar

Pharmacovigilance in Myanmar is overseen by the Department of Food and Drug Administration (Myanmar FDA) under the Ministry of Health, which is responsible for the safety, quality and regulatory control of medicines throughout their lifecycle. The FDA continues to operate a national adverse-drug-reaction reporting mechanism and, most recently, published an official Burmese-language ADR Report Form announcement on 1 June 2026, confirming the continuing use of formal ADR reporting to the authority. For medicinal-product registration, the FDA’s current Drug Registration SOP incorporates the ASEAN Common Technical Dossier (ACTD) and requires identification of the marketing authorisation Holder (MAH), submission of relevant clinical safety information and, where applicable, reports of post-marketing experience; the document also refers to active post-marketing monitoring for well-established medicinal products. These requirements support an ongoing responsibility for MAHs to monitor the safety profile of marketed products and ensure relevant safety information can be communicated to the Myanmar FDA. However, the currently accessible Myanmar FDA materials reviewed do not clearly establish a universal numerical MAH ICSR reporting timeframe, a mandatory Myanmar-resident QPPV, a PSMF requirement, a fixed PSUR/PBRER submission schedule, or a specific pharmacovigilance-inspection frequency applicable to all MAHs. Those elements should therefore not be presented as binding national requirements unless confirmed through a product-specific approval condition or further instruction from the Myanmar FDA. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.