Dutch, Swiss Regulators Forge Agreement on Data Exchange
Posted 14 September 2018 | By
The heads of the Netherland’s Medicines Evaluation Board (MEB) and Swissmedic on Tuesday signed a memorandum of understanding (MoU) allowing for greater collaboration between the two regulators.
According to a joint release by both regulators, the agreement “provides a formal basis for stepping up collaboration on bilateral initiatives and the exchange of data” and adds to their ongoing participation in international efforts such as the International Coalition of Medicines Regulatory Authorities (ICMRA) and International Council for Harmonisation.
“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,” the regulators write.
The agreement comes six just months before the European Medicines Agency (EMA) is set to relocate to Amsterdam, just miles from MEB’s headquarters in Utrecht. While Swissmedic is not an EMA member, it maintains a confidentiality agreement and mutual recognition agreement on good manufacturing practice compliance with EMA.
The MoU also brings the total number of agreements on information exchange
, including confidentiality arrangements, MoUs and other bilateral exchanges, that Swissmedic is a party of to 20.