In 2015, Swissmedic, the Swiss Agency for Therapeutic Products and the Swiss Agency for Development and Cooperation (SDC), started supporting the efforts of the African Medicines Regulatory Harmonization Initiative (AMRH). The aim is to strengthen capacities and harmonized procedures of national medicines regulatory authorities working within a regional regulatory network and thereby to accelerate access to safe and efficacious quality therapeutic products for the African population.
In this context, Swissmedic has set up a Marketing Authorisation for Global Health Products Procedure and a Procedure for Providing Scientific Advice which is accessible to manufacturers interested in developing products specifically for low- and middle-income countries and which could be used to help inform regulatory decisions by regulatory authorities from resource-constrained countries and the WHO. The aim is to help accelerate subsequent WHO pre-qualification and national/regional medicine evaluation and registration. It is expected that the timelines for the WHO-PQ listing and marketing authorisation by the participating regulatory authorities will be significantly reduced because they have access to the outputs of the MAGHP procedure and have gained confidence in using its outcome. Overall, this should lead to a faster access to those medicines for the patients in need.
Swissmedic and SDC will further inform on the procedures at the event
“A contribution to accelerating access to quality medical products in low and middle-income countries - the Swiss Marketing Authorisation Procedure for Global Health Products”.
The event will take place in
Geneva, at the CICG (Centre International de Conférences Genève, Rue de Varembé 17) on
3rd April 2017 (14.30 – 16.30, followed by a reception).
We would be grateful if you could let us know by 24th March 2017 at the latest, whether you will attend. Please send your reply to networking@swissmedic.ch
In case of any questions, we remain at your disposal (networking@swissmedic.ch) and for further information on this initiative please refer to the Swissmedic website.
Further information