Medicines and Medical Devices Regulatory Agency
Medicines and medical devices regulator
Mongolia's medicines and medical devices regulator. The Government established it by Decree No. 222 on 16 December 2020 to unify regulation that had previously been split between the Ministry of Health, the Centre for Health Development and the relevant departments of the General Agency for Specialized Inspection, and to overcome that inconsistent and inefficient structure (GRATA International Mongolia, legal alert on the new Medicine and Medical Devices Regulatory Authority).
The agency registers medicines and bioactive products, licenses manufacture and sales, issues quality assurance and Good Manufacturing Practice certificates, conducts specialised inspection of pharmacological activities, controls side effects, grants marketing authorisation, and monitors and evaluates the assortment and prices of vital and essential medicines (GRATA International Mongolia, legal alert, April 2021).
PEOPLE
Altantsetseg Purvee
Director - named as Director of the Medicine and Medical Device Regulatory Agency in the UNDP Mongolia press release of 10 April 2026 on the essential medicines procurement agreement
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Tsetsegsaikhan Batmunkh
Director, first director - appointed Director of the newly established agency in June 2021 (UICC, 30 June 2021)
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RECORD
WHO benchmarking - November 2022
A WHO mission team worked in Mongolia from 14 to 18 November 2022 at the request of the Minister of Health to support a formal national regulatory authority assessment. On 14 to 16 November 2022 the team ran a training exercise for agency staff on the WHO global benchmarking self-assessment tool, covering nine functions from the national regulatory system and registration to vigilance, market surveillance, laboratory testing and clinical trials oversight (WHO Mongolia, 18 November 2022).
The quality problem in the record
A study published in BMC Public Health in 2020 analysed 1,770 samples of 15 medicines collected in Ulaanbaatar and four provinces in June and July 2017. It found 179 samples, 10.1 percent, failed pharmacopoeial tests, and 76 samples, 4.3 percent, were unregistered in Mongolia, with substandard prevalence higher for locally produced products than for imported equivalents (BMC Public Health, 2020).
UNDP essential medicines agreement - 2026
On 10 April 2026 UNDP Mongolia and the agency signed a Project Document and Financing Agreement for the Procurement of Essential Medicines project, a three-year initiative applying internationally recognised procurement and quality assurance standards, intended in particular to ensure uninterrupted access for patients living with hemophilia, with the agency as the technical counterpart (UNDP Mongolia, 10 April 2026).
A filled seal is documented. An open seal is an allegation, source named.
How to read this page. Every line names its source. A line marked ALLEGATION is a claim already published by the named source and already in the public record. Decode Mongolia republishes it as reported, with the source named, and has not verified it. An allegation is not a finding, and nothing on this page is proof of wrongdoing.