Snapshot

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

This pathway can be used where All product types can use this pathway. However, products that are of unique value to low and middle income countries or to those countries with less mature regulatory organizations will be of particular interest for the process. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The procedure and timelines follow the regular marketing authorization procedure at Swissmedic. Applicants are requested to submit a prior-notification about three to six months before the planned submission date in order to allow proper planning of resources and involvement of representatives from target national medicine regulatory authorities as well as the WHO. The applicant determines which target countries will be invited to participate in the process. Swissmedic makes available advice sessions with the applicant, but the applicant must commit to submitting the product via this pathway. The agency also conducts a kick-off with the national regulatory authorities. Decision (Day 330): The process can include up to two review cycles with the applicant. Swissmedic sends the final decision to the applicant and makes it available to the NMRAs concerned and WHO via the electronic platform. In the case of a positive decision the Swiss marketing authorization or export registration is granted. The NMRAs concerned will decide and confirm their decisions within 90 days of the date on which Swissmedic sent the decision to the applicant. (Day 420). Product's authorized by the MAGHP process can also be considered for the WHO PQ Procedure and Collaborative Registration Procedure (both described in FRPath)