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EMA gets to work on bringing more advanced therapies to market

This article was originally published in RAJ Devices

Executive Summary

The European Medicines Agency's Committee for Advanced Therapies will look at how the regulatory framework around advanced therapies such as gene therapy and regenerative medicine can be made more accessible for small and medium-sized firms, academia, patient groups, hospitals, charity foundations and trusts that develop advanced therapies1,2. The EMA admits that the current framework is very complex and that many SMEs and academics lack the financial and human resources to negotiate it. Often developers do not have the resources to bring their products, which are sometimes fairly mature, to regulatory standards, says the EMA.

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