Swissmedic Annual Report 2018

82 Stakeholder management
International Generic Drug Regulators Programme
(IGDRP) – were presented. Furthermore, the Agency had
an opportunity to introduce itself and its work to
attendees at its “Taste the Innovation” stand.
Development cooperation
Swissmedic has been involved in two development cooperation
projects since 2015. This involvement is based on a
memorandum of understanding (MoU) with the Bill &
Melinda Gates Foundation (BMGF), the FDHA and the
FDFA. The overriding aim of cooperation is to help improve
and expedite access to healthcare and medicines in low-resource
countries.
Activities
• Finance agreement between Swissmedic and Bill &
Melinda Gates Foundation
Swissmedic is currently implementing a finance agreement
with the Bill & Melinda Gates Foundation which
originally covered the period from 2016 to the end of
2018. Under this agreement, the services that Swissmedic
provides are defined by specific measures.
However, since projects have been slower getting off
the ground in the past three years than originally
planned, the agreement has been extended by one year
to the end of 2019. Swissmedic will continue to
implement the agreement throughout the year.
• Supporting the African Medicines Regulatory Harmonisation
(AMRH) initiative
The first development cooperation project in which
Swissmedic is involved provides support for the African
Medicines Regulatory Harmonisation (AMRH) initiative,
focusing primarily on the East African Community (EAC)
and the Economic Community of West African States
(ECOWAS). During 2018, Swissmedic continued to
support the EAC’s joint assessments in various ways,
including contributing its clinical expertise in reviewing
authorisation dossiers. The Agency also helped the East
African Community develop harmonised guidelines and
provided on-the-spot support for information management
systems by attending meetings of the relevant
working groups. Swissmedic was also represented at the
three EAC steering meetings. The first Steering Committee
meeting for the West African Medicines Regulatory
Harmonization (WA-MRH) programme took place in
Ouagadougou, Burkina Faso, in July 2018. Swissmedic
took part in the meeting, giving a presentation of the
cooperation options to the 15 attending ECOWAS
countries and the WA-MRH programme secretariat.
• Marketing Authorisation Procedure for Global Health
Products (MAGHP)
Under the second development cooperation project,
African regulatory authorities and the WHO are included
in a Swissmedic evaluation process for products to treat
diseases that primarily affect people in southern Africa.
New applications for medicinal products containing
either new or known active substances are eligible for
this Marketing Authorisation Procedure for Global
Health Products (MAGHP), as are extensions into new
applications. The MAGHP also provides a channel for
obtaining scientific advice; the procedure is in the pilot
phase, and initial experience is being acquired.