WHO mission team led by Dr Jinho Shin, Acting Coordinator of Essential Medicine and Technology, is working in Mongolia during 14-18 November 2022 at the request from Dr S. Enkhbold, Minister of Health in Mongolia, to WHO to get support for formal NRA assessment. Today, the mission team conducted “Medicine Price, Substandard and Falsified (SF) Medicine Regulation” workshop.
Minister of Health Dr S. Enkhbold mentioned during his opening remark “Standing Committee to review the quality and safety of medicines was established by the State Great Khural. The Government of Mongolia is working on the revision of the Law on Medicines and Medical Devices as regulation is required for medicine price, quality, and safety. I would like to express my gratitude to the mission team for accepting our request to provide information on WHO policies on medicine prices and SF medicine. WHO recommendations and suggestions will be highly considered in the law revision.”
On 14-16 November 2022, the mission team organized training exercise on how to use WHO global benchmarking self-assessment tool for the staff of the Medicine and Medical Devices Regulatory Agency covering the following 9 functions:
- National Regulatory System
- Registration and Marketing Authorization
- Vigilance
- Market Surveillance and Control
- Licensing Establishments
- Regulatory Inspection
- Laboratory Testing
- Clinical Trials Oversight
- NRA Lot release
The self-assessment which is conducted in Mongolia in every 2-4 years is essential to develop action plan on medicine regulation to be implemented in the near future, and to strengthen the cooperation with international organizations.