Mongolia

Pharmacovigilance in Mongolia is regulated by the Medicines and Medical Devices Regulatory Agency (MMRA). Mongolia updated its pharmacovigilance framework in 2025 through the Mongolian-language A/128 order, published by MMRA as Фармаковижилансийн үйл ажиллагааг зохицуулах тухай. The order establishes national procedures for pharmacovigilance activity, including adverse-reaction and safety reporting, and MMRA publicly assesses periodic medicine-safety information, including PSUR data and risk-minimisation measures. The authority also maintains national эмийн гаж нөлөөний мэдээлэл / ADR reporting functions. Because the currently accessible public extract is not sufficiently clear to support an EU-style statement for every product, this consolidated file does not assert a universal Mongolia-resident QPPV, PSMF requirement, single numerical MAH ICSR deadline, or fixed PSUR/PBRER frequency unless those requirements are confirmed in the applicable A/128 annex, registration condition or MMRA instruction. MAHs should maintain local safety monitoring and comply with MMRA reporting, periodic-safety and risk-management requirements applicable to their products. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.