The aim of project component III is to offer capacity-building hands-on training courses for National Regulatory Authorities (NRAs) in low- and middle-income countries, so that they can function more effectively.
Swissmedic Regulatory Training
In partnership with the WHO, Swissmedic devised a comprehensive regulatory training course for regulatory authorities. Such courses are part of the WHO’s programme to improve its member states’ regulatory systems. The regulatory training is structured as a “peer learning” event, i.e. learning goals are achieved primarily through interaction with other specialists and colleagues. In this four-day workshop, participants gain a better understanding and acquire new skills for developing and implementing their knowledge of regulatory processes and approaches. The presentations and discussions enable the participants to better understand the processes, approaches and strengths of both Swissmedic and visiting NRAs as well as the challenges facing them.
In addition to a general section, the workshop is partly conducted in three parallel modules:
- Marketing authorisation
- Market surveillance/pharmacovigilance
- Quality management system/GMP inspections
Swissmedic holds this regulatory training in partnership with the WHO twice a year. Eight authorities are invited to send three experts to each course. Six of these authorities are invited by the WHO, two by Swissmedic. To ensure the long-term sustainability of the project, the foreign authorities are required to submit an action plan to the WHO, setting out how they intend to implement the knowledge acquired by participants.
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In addition to the general training outlined above, Swissmedic also conducts targeted training on specific topics, such as a training session on reviewing inhalation products, which has been held annually since 2020.
Swissmedic GMP Training
Swissmedic organises a regular GMP Training workshop for GMP inspectors from foreign authorities once a year.
In the context of its collaboration with the WHO and the Swiss Development Cooperation Agency (SDC), Swissmedic supports inspectors from African Regional Economic Communities (RECs) in attending this training workshop. The WHO covers the costs and travel arrangements for the nominated participants.
Guided GMP inspections
At the WHO’s request and based on needs on the ground and the available capacities, Swissmedic offers the opportunity for inspectors from foreign authorities in LMICs to shadow a team of Swissmedic inspectors during a GMP inspection. Swissmedic organises a simultaneous interpreting service and ensures that all aspects of security and confidentiality are complied with.
- Study on the impact of Swissmedic regulatory training:
Frontiers | Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic (frontiersin.org)
 As defined by the World Bank
Last modification 02.11.2023