On September 11, 2018, a memorandum of understanding (MoU) was signed by the heads of Swissmedic and the Netherlands Medicines Evaluation Board (MEB). This MoU allows for a better and more stable collaboration between these regulators of medicines and medical devices.
The regulators comment that this agreement is pertinent “given the constantly evolving regulatory environment and the ever more global and complex nature of therapeutic product development and production, international collaboration is an important factor in meeting the growing challenges.” This initiative will further strengthen the international effort both countries are actively participants in, including the International Council for Harmonisation.
Swissmedic is now a part of twenty agreements on information exchange, now including this MoU as well as other confidentiality agreements and bilateral exchanges.
In six months the European Medicines Agency (EMA) is going to relocate to Amsterdam, just a few miles from Utrecht, the location of the current MEB’s headquarters. Though Swissmedic is not a member of the EMA, there is a confidentiality and mutual recognition agreement between the two on good manufacturing compliance.
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