Swissmedic grants authorisation for a paediatric antimalarial under the Marketing Authorisation for Global Health Products (MAGHP) procedure

Swissmedic has authorised a novel paediatric formulation of an antimalarial medicine: Riamet Baby (Coartem Baby), specifically developed for infants with a bodyweight between 2 kg and 5 kg. This marks a significant step in the global effort to improve access to life-saving treatments for vulnerable populations. It is the third authorisation granted under the MAGHP procedure and underscores the value of international collaboration in addressing urgent public health needs.

Swissmedic has granted marketing authorisation for Novartis Riamet Baby, also known as Coartem Baby, a novel antimalarial medicine specifically indicated for infants weighing between 2 kg and 5 kg. This is the third authorisation to be granted under the MAGHP procedure, reflecting the continued development of this collaborative initiative aimed at improving access to high-quality medicines in low- and middle-income countries.

The newly authorised product addresses a critical treatment gap for one of the most vulnerable patient populations—young infants suffering from malaria. The availability of a formulation specifically designed for children under 5 kg marks a significant step forward in the global fight against malaria.

The authorisation procedure involved close collaboration with national regulatory authorities (NRAs) from eight African countries: Burkina Faso, Côte d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Uganda, and Tanzania. The World Health Organization (WHO) Global Malaria Programme also participated in the scientific assessment.

In the next phase of the procedure, the applicant is expected to submit the dossier to the participating NRAs, which are expected to approve it in their respective jurisdictions within 90 calendar days from receipt. This step is key to ensuring timely national access to the product following the collaborative assessment.

Strengthening regulatory capacity through MAGHP

The MAGHP procedure enables Swissmedic to share its scientific and regulatory expertise with regulatory authorities in targeted countries, thereby supporting regulatory capacity building while accelerating access to innovative treatments. The involvement of local regulators throughout the procedure ensures that their specific needs, requirements, and public health priorities are considered from the outset.

The success of this MAGHP procedure further demonstrates the value of international cooperation in addressing global health challenges and ensuring that life-saving medicines reach those who need them most – swiftly and safely.

For more information on the MAGHP procedure, please visit: