Snapshot

The Marketing Authorisation for Global Health Products (MAGHP) Light Procedure pathway has been developed by the of Switzerland.

This pathway can be used where All products are eligible; there is no restriction to specific indications..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The MAGHP Light procedure was originally initiated as a response to the global COVID-19 pandemic and the need to accelerate the review processes and global access to life-saving medicines for the treatment of COVID-19. However, the geographical and medical scope of the MAGHP Light procedure is identical to the standard MAGHP procedure. The MAGHP “Light” procedure, applies to applications in the Fast track and Temporary authorisation procedures. No other formal criteria must be fulfilled. The MAGHP Light procedure foresees a one-directional exchange of documentation with the participating NRAs. The timelines valid for the MAGHP Light procedure depend on the specific timelines set for the type of application and procedure. In contrast to the standard MAGHP procedure, the MAGHP Light procedure does not imply expectations regarding the national decision phase in the targeted countries.