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), Project Component II aims to make the Swissmedic authorisation procedure and the procedure for providing scientific advice accessible to representatives of regulatory authorities in these countries as well as to the WHO. Although other countries or regions may be involved, the focus is on sub-Saharan Africa and on medicinal products for those diseases that affect the region disproportionately. 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.
Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP)
Related documents
Procedure for Scientific advice meetings during the developmental phase of a medicinal product intended for submission under the Swissmedic Marketing Authorisation for Global Health Products (MAGHP)
Procedure for Marketing Authorisation 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)
Last modification 02.11.2023