The Swiss Agency for Therapeutic Products (Swissmedic) provided a further training course on regulatory issues at the end of April 2019 as part of its development cooperation. Participants were able to share ideas and experience concerning best practices in the areas of quality management, marketing authorisation and market surveillance.
Through the WHO, representatives of the regulatory authorities in Ethiopia, Eritrea, Tanzania, Kenya, South Sudan and the Democratic Republic of Congo took part in the four-day workshop. Representatives of the Malay and Turkish authorities were invited directly by Swissmedic. The feedback from representatives was positive: they particularly appreciated the open exchange of information, suggestions for streamlining work processes – such as division of labour and risk-based approaches – and discussions regarding experiences and potential measures for developing national regulatory capacity.
Following a Management Board decision, visits and training courses have been organised and structured more efficiently since last year. The development cooperation training concept was drafted jointly by Swissmedic and the WHO, then tested in a pilot scheme in November 2018 and subsequently refined. The training concept has a modular structure and focuses on the issues of quality management systems, marketing authorisation and market surveillance.
The Regulatory Training Workshops are part of Swissmedic’s mandate in the area of development cooperation. They are funded by third-party resources under an agreement between the Federal Department of Home Affairs (Swissmedic), the Federal Department of Foreign Affairs (Swiss Agency for Development and Cooperation) and the Bill & Melinda Gates Foundation.
In partnership with the World Health Organization (WHO), Swissmedic devised a training course for regulatory authorities in low- and middle-income countries. Such courses are part of the WHO’s programme to improve its member states’ regulatory systems. The aim of the programme is to develop the knowledge available within authorities in such a way that they can function effectively and perform their regulatory duties.
Swissmedic now intends to hold training courses in partnership with the WHO twice a year. Eight authorities will be invited to send three experts to each course. Six of these authorities will be chosen by the WHO, two by Swissmedic itself. 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.