So for the FDA, the time of approval as the endpoint for market authorization is appropriate. In Europe, the EMA's process involves one more step, creating an intermediate time point that seems to ...
In October, the EMA announced that it was looking to improve the efficiency of its approval process for new medicines in the European Union (EU). The stated aim for the agency was to better manage ...
GlobalData on MSN1mon
Italian charity seeks EMA approval for rescued gene therapyTelethon has submitted a marketing authorisation application (MAA) to the European Medicine’s Agency (EMA) for evaluating ...
uncertainties inherent in the regulatory approval process could impact the timing, progress, and outcome of the EMA’s review; potential delays or difficulties in commercializing mavorixafor in ...
uncertainties inherent in the regulatory approval process could impact the timing, progress, and outcome of the EMA’s review; potential delays or difficulties in commercializing mavorixafor in ...
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
The Montreal-based C3i Center obtained regulatory approval from the European Medicine Agency (EMA) to produce cell therapy therapies for the European market. The company obtained a certificate of ...
This approval marks a major regulatory milestone ... The PDCO issues an opinion on PIP as part of the regulatory process and the EMA adopts a final decision based on the PDCO's opinion.
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