Swissmedic extends the MAGHP procedure

The new Light procedure builds on the established MAGHP procedure, but is explicitly applicable to applications for the fast-track authorisation procedure and for temporary authorisation


The aim of the Marketing Authorisation for Global Health Products (MAGHP) programme is to make Swissmedic’s authorisation procedure accessible to regulatory authorities in low and middle-income countries.
The new MAGHP Light procedure was originally launched in response to the global COVID-19 pandemic with the aim of accelerating review processes and global access to life-saving medicines to treat COVID-19. However the medical scope of the MAGHP Light procedure should not be limited to COVID-19 medicines

In the MAGHP Light procedure, on request and with the applicant's agreement, selected therapeutic products authorities will be granted access to the application dossier and the documents created by Swissmedic during the assessment process (evaluation reports, information for healthcare professionals, correspondence). The authorities involved can thus develop their own capacities and their trust in the procedure, while at the same time enabling rapid access to life-saving medicines for their populations.
To ensure that applications are processed quickly, unlike the standard MAGHP procedure there is no active exchange with the authorities involved during the assessment process.

The MAGHP procedure is being implemented as part of the cooperation with the World Health Organization (WHO), the Swiss Agency for Development and Cooperation (SDC) and the Bill & Melinda Gates Foundation (BMGF).

Further information and the revised guidance document for the procedure can be found on our website using the following link: