Development Cooperation – Regulatory Systems Strengthening

In 2013 the Federal Council issued a revised mandate to Swissmedic (Link) to conduct projects in the area of development cooperation, in conjunction with the Swiss Agency for Development Cooperation (SDC) and/or non-profit organisations, provided that the funding of the activities (at full cost) is guaranteed through the financial resources of the “International Cooperation Strategy 2013-2016” (of the SDC) and/or of the non-profit organisations. In addition, the independence and functioning of Swissmedic must not be put at risk by these activities.

In view of the above, the Bill & Melinda Gates Foundation (BMGF), the Federal Department of Home Affairs (FDHA) and the Federal Department of Foreign Affairs (FDFA) agreed in January 2014 on a Memorandum of Understanding (MoU) (Link) to improve and accelerate access to health interventions and therapeutic products in resource-constrained countries by strengthening regulatory systems, focussing on countries in sub-Saharan Africa. The overall aim of the project is to bring high-quality, life-saving medicines to patients as quickly as possible. This is to be achieved by leveraging and coordinating resources through cooperation between the three parties to the MoU and the WHO. The engagement of Swissmedic was re-confirmed by the Federal Council in October 2018 through its strategic objectives for 2019-2022 (Link). According to these objectives, efforts should focus on improving access to therapeutic products by strengthening regulatory systems in low- and middle-income countries (LMICs) with a focus on sub-Saharan Africa. The support is also aligned with the Swiss Health Foreign Policy (Link).

The following three project components have been developed and are being implemented:

  • Project Component I: Support for the implementation of the African Medicines Regulatory Harmonization (AMRH) Programme (Link)
  • Project Component II: Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP) (Link)
  • Project Component III: Swissmedic Regulatory Training (Link)