Published: 7 October 2025

PrEP approved for registration in Mongolia

There has been some historic news out of Mongolia, after the landlocked country added pre-exposure prophylaxis (PrEP) to its list of registered medicines. This has massive implications for Mongolia’s HIV response, paving the way for open distribution and a landscape where those who need it can freely access PrEP.

A big congratulations to Mongolia, and to the key players who made this happen. This included Health Equity Matters’ SKPA-2 Senior Program Officer and public health professional Dr. Setsen Zayasaikhan, who was a driving force behind PrEP’s official registration.

Chair of the Global Fund’s Country Coordinating Mechanism (CCM) in Mongolia, Tuya Badarch, said:

‘Thanks to the support of the SKPA-2 project, PrEP is now registered in Mongolia. Despite stigma and conflicting policies, the Country Coordinating Mechanism is committed to making it truly accessible for those who need it.’

Head of AIDS/STI Surveillance and Research Department in Mongolia’s National Center for Communicable Diseases (NCCD), Dr. Tumenjarga. B added:

‘PrEP has been in high demand among key populations, and its registration is a significant achievement toward open distribution.’

Getting to this point was far from a straightforward process. Under Health Equity Matters’ SKPA-1 project in 2021–22, Mongolia piloted oral PrEP delivery in a successful demonstration project that established standard operating procedures, eligibility criteria and community-based implementation models. However, after this initial breakthrough, implementation stalled due to a myriad of policy and regulatory barriers.

Currently, only a small handful of people in Mongolia are receiving PrEP, through Youth for Health Center’s community centre, in line with the National Guideline on PrEP developed under SKPA-2 and endorsed by the Ministry of Health’s Technical Committee of STI and AIDS.

Crucially, the country’s NCCD is unable to distribute PrEP more broadly because it’s not included in the list of diagnoses and related medicines covered by the government.

Without systemic integration into national frameworks such as official registration, PrEP has long remained inaccessible to the general population including communities at high risk of contracting HIV.

Official registration changes all that.

After the Ministry of Health made the historic decision to register PrEP, the NCCD will now move to include PrEP in the country’s Essential Medicines List. In combination with registration, this will allow distribution of PrEP by the NCCD, meaning that key populations who most need PrEP will finally be able to access it.

Partnership was critical to making this possible. Dr Setsen said:

‘It has been a journey to get PrEP registered and was only achievable thanks to collective effort.

 

‘We leave behind a good roadmap on PrEP supply that clearly states what should be done.’

Looking ahead, and the job is far from over.

To establish PrEP services sustainably, Mongolia must prioritise and accelerate structural policy reforms and operational readiness.

Dr. Tumenjarga. B from the NCCD observed:

‘We still have a long road ahead. Our main objective is to have PrEP fully covered by public health insurance. Currently, to receive PrEP, individuals must undergo HIV testing and [receive a negative HIV] diagnosis.’

SKPA-2 consultant Khaliunaa Mashbaatar sees the registration of PrEP as just the starting point and a catalyst of bigger strides in public health to come. She said:

‘The fact that we have successfully registered PrEP for the first time is a historic milestone and an important event that has opened a new path for the state to register drugs that have not been registered until now.

 

This opens the door for Mongolia to enter a new phase of formalising sustainable, science-based HIV prevention measures, providing an important impetus to achieving the global goal of ending the AIDS epidemic by 2030.’

Health Equity Matters’ Principal Director of International Programs, Felicity Young AO, spoke about this landmark moment for Mongolia, and the part SKPA-2 played. She said:

‘While SKPA-2 is transitioning out of Mongolia, we will be watching with interest. We are proud to have played a role in making PrEP access possible for those who need it and thank all of our colleagues and partners for coming on this journey with us.’