Jul 8, 2019
EU MDR/IVDR
On Friday, the European Medicines Agency (EMA) released two guidance documents addressing issues surrounding drug shortages in the EU, and how to manage drug shortages publicly. These documents were created by a task force specifically to aid in companies’ reporting...
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Jun 4, 2019
Europe
European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of devices. This particular regulation specifies the...
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Mar 11, 2019
EU MDR/IVDR
The European Medicines Agency (EMA) recently released a guidance document regarding the new EU MDR, which will go into full effect in May 2020. This guidance focuses on the responsibility manufacturers will take in the registration process for combination devices with...
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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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Jun 28, 2018
Europe
The final stages of the U.K.’s withdrawal from the European Union are quickly approaching, which means many critical things for the pharmaceutical and medical device industries. To facilitate the preparations drugmakers must make to remain in compliance with...
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