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The European Medicines Agency (EMA) is moving ahead to relocate to one of the remaining 27 European Union member states. The Europen Council is expected to make a decision on the new location in October of this year. The agency has begun impact assessment studies to help prepare for the move and retain as many staff as possible, according to the EMA.
The EMA has started on the re-distribution of the workload relating to the evaluation and monitoring of medicines to ensure the quality of EMAs scientific assessments and compliance with legal timelines. There is a group for human medicines and one for veterinary medicines to allocate the workload.
The agency is also working on the provision of guidance and information to pharma companies.
Additionally, the EMA announced that the EU clinical trial portal and database’s go-live date has been postponed, due to technical issues with the IT systems. EMA said it is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress.
The agency will provide an update at the next meeting of the Management Board in October 2017. Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled.