Support for global regulatory harmonisation and system-strengthening programmes

WHO Coalition of Interested Parties (CIP) Network

Since 2022, Swissmedic has been an official member of the WHO Coalition of Interested Parties (CIP). The aim of the CIP is to develop and promote a consistent global strategic and coordinated approach to strengthening national and regional regulatory systems in order to improve access to safe, effective, high-quality medical products.

Support for regulatory strengthening and harmonisation in Africa

Swissmedic’s initial support in this area focused on the East African Community (EAC), the first Regional Economic Community to secure funding under the African Medicines Regulatory Harmonization (AMRH) Programme. Subsequently Swissmedic extended its support to regional harmonisation initiatives launched by other African RECs.

At continental level, Swissmedic started its support for the AMRH Programme in 2017. In February 2018, the African Union Development Agency (AUDA-NEPAD), issued a call for expressions of interest in joining the African Medicines Regulatory Harmonization Partnership Platform (AMRH-PP). The AMRH-PP was created as a mechanism for efficiently coordinating efforts, fostering transparency and supervising the various partners and interest groups supporting the AMRH Programme. 

In 2022, Swissmedic was elected Chair of the Technical Partners Group (TPG) at the AMRH-PP. The aim of this group is to coordinate the technical resources of the various partners and distribute them efficiently and according to needs in the various areas of implementation at national, regional and continental level.

Swissmedic was an official technical partner (member) of the AMRH-PP until the AMRH initiatives were transferred from AUDA-NEPAD to the African Medicines Agency (AMA). In this new context, Swissmedic remains committed to its mission and works closely with AMA and a group of recognised partners to support AMA operationalisation efforts and the implementation of its strategic plan.

WHO Global benchmarking for evaluation of national regulatory systems

Since 1997 the WHO has assessed regulatory systems using a set of indicators designed to evaluate the regulatory programme for vaccines. With the latest Revision VI, the current global benchmarking tool (GBT) is now the first “global” tool for benchmarking regulatory systems, replacing all tools previously used by the WHO. Swissmedic experts support the WHO Benchmarking Programme by contributing expertise to its missions on request.