Taking Part In The Adaptive Licensing Experiment
The EMA's practical guide to what happens when a company applies to take part in the adaptive licensing experiment.
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MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.
The EU's adaptive licensing pilot project, which was launched in March 2014, is designed to deliver an early centralized marketing license for promising innovative therapies for patients with serious or life-threatening conditions. However, while the benefits are clear, there are a number of challenges that will need to be addressed.
Industry’s message may continue in a similar vein, but the urgency over the implementation of the EU IVDR has grown to a point where it is desperate for some solution to what it sees as an impending disaster for IVDs in the EU.