How is the EMA helping communities make a difference to the global response to HIV and AIDS?

The European Medicines Agency (EMA) is contributing to the global response to HIV and AIDS through scientific evaluation, supervision and safety monitoring of medicines, and active patient engagement.

Patients are involved in early development and evaluation of HIV medicines, to provide valuable insights based on their real-life experiences with the disease and its treatment. They contribute to meetings of the EMA’s committees and scientific advisory group, reviewing information and communication materials for HIV medicines. Scientific guidelines and advice from the EMA help medicines manufacturers convert advances in medical science into essential medicines, which can bring wider health benefits to people living with HIV.

Furthermore, the EMA has provided scientific advice to enable the development of potential HIV vaccines, in addition to the pre-exposure prophylaxis (PrEP) medicines which have already been authorised via centralised procedures. These prevention strategies will provide people at higher risk of HIV infection with more options for prevention.

The EMA’s paediatric committee (PDCO), which defines paediatric needs and ensures children are included in safety and efficacy studies, is committed to including adolescents in critical trials to assist rapid approvals of HIV treatments. 43 HIV medicines have been approved for children and adolescents.

Did you know that all antiretroviral medicines must be centrally authorised in the European Union (EU)? This allows people living with HIV to have quick access to potentially lifesaving treatments.

Through international collaboration with the World Health Organisation (WHO) and other regulatory bodies, the EMA is supporting initiatives to improve global access to treatments. They have provided three scientific opinions on anti-retrovirals intended for use outside the EU, in low and middle income countries.

“Working with HIV advocates and people living with HIV has been instrumental in developing EMA’s policies, guidelines and regulatory processes.”

The EMA has detailed their global efforts in a factsheet.