Fastest Ever Review For A Product In EMA's PRIME Scheme
The European Medicines Agency says that when it comes to products developed under its priority medicines scheme, dialog is crucial to ensure that the data generated for marketing applications are sufficiently robust and mature and facilitate a timely review.
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Requests For EMA PRIME Designation Fall But Improvements Are On The Way
While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Tibsovo, Servier’s treatment for IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.
Europe's Unitary Patent System Starts Up Today
The forthcoming unitary patent system and Unified Patent Court promise to make applying for patents in Europe and litigating infringements simpler and less costly for applicants.