In line with the project’s overall objective to improve and accelerate access to health interventions and therapeutic products in low- and middle-income countries[1] (LMICs), the area of engagement “Access” aims to make the Swissmedic authorisation procedure accessible to representatives of regulatory authorities in these countries as well as to the WHO. At the request of the applicant, clarification of content and procedural questions within the framework of a meeting before application submission may also be carried out in cooperation with other authorities and the WHO (see guidance document below). Although the focus is on sub-Saharan Africa and on medicinal products for diseases that disproportionately affect the region, other countries or regions may also be involved,. The procedure builds on the normal procedure for Marketing Authorisation for Medicinal Products. The National Regulatory Authorities (NRAs) are invited to participate actively in the assessment, with the aim of building their own capacities and establishing confidence in the process. Moreover, it is expected that the timelines for the marketing authorisation by NRAs will be significantly reduced, making essential medicines available for patients faster.
Related documents
Meetings before application submission within the framework of the MAGHP
Marketing Authorisation Procedure for Global Health Products (MAGHP)
Relevant Administrative Ordinances
[1] As defined by the World Bank
(https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups)
Virtual Event on the MAGHP Procedure
10.03.2021
Swissmedic extends the MAGHP procedure
01.10.2020
Last modification 25.08.2025