Jul 17, 2020
Europe
Swissmedic, the Swiss agency for therapeutic products, announced the implementation of a new technical standard to be used when submitting a marketing authorization application for a medicinal product. The present document constitutes an improved version of the...
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Sep 17, 2018
Europe
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...
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Jul 24, 2018
Europe
Swissmedic, Switzerland’s pharma and medical device authority, will swap out its current methods for issuing export and manufacturing certificates for a new online system this fall. Going digital will help the authority prevent bottlenecks and free up resources...
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Jun 7, 2018
North America
From 2007 to 2016, the internalization of more new active substances (NASs) has allowed for extensive opportunity in the market. These changes have favored a smaller margin in approval times and a larger opportunity to extend them to patient populations globally....
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