Committee for Advanced Therapies adopts five-year work programme to foster development of advanced therapies
Work programme 2010-2015 aims to help bring more advanced-therapy medicines to the market
The European Medicines Agency's Committee for Advanced Therapies (CAT) has unveiled a Work Programme to 2015, intended to help increase the number of advanced-therapy medicinal products (ATMPs) that make it from the early research stage to the market.
The last decade has seen intensive research and development in gene therapy and regenerative medicine, including tissue engineering and somatic cell therapy. These advanced therapies offer potentially groundbreaking new treatments for diseases and injuries to the human body. However, despite their huge potential, only very few applications for marketing authorisation for ATMPs have so far been submitted.
With its five-year work programme, the CAT aims to contribute to an environment that encourages the development of ATMPs. Recognising that the traditional regulatory framework for medicines does not currently fully address the needs of companies and organisations that develop these medicines, the work programme sets out a proactive approach for the CAT, in which training and early dialogue with relevant stakeholders play a central role.
In the context of the work programme, the CAT will also look at the current regulatory framework and at how it can be made more accessible for small and medium-sized enterprises, academia, patient groups, hospitals, charity foundations and trusts developing ATMPs.
The actions proposed tie in with the Agency's Road Map to 2015 that has identified new and emerging science as an important driver for progress and change in the healthcare field. The CAT has already started work on some of the actions proposed in the work programme. The Committee will provide regular update reports as the work progresses.