The European Medicines Agency (EMA)’s Committee for Advanced Therapies (CAT) has unveiled a Work Programme to 2015, which is 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, which offer potentially groundbreaking new treatments for diseases and injuries to the human body, says the Agency. However, and despite their huge potential, only very few applications for marketing authorisation for ATMPs have so far been submitted.
Some products appear to be in a more mature state but lack the resources to be brought up to regulatory standards. Moreover, CAT notes that “interested parties” and patients’ organizations have warned that such hurdles are limiting the timely access by patients to potential effective treatments.
The new five-year work programme aims to contribute to an environment that encourages the development of ATMPs. The traditional regulatory framework for medicines does not currently fully address the needs of companies and organisations that develop these medicines, so the programme sets out a proactive approach for CAT, in which training and early dialogue with relevant stakeholders play a central role, says EMA.
CAT will also examine the current regulatory framework and look at how it can be made more accessible for small and medium-sized enterprises (SMEs), academia, patient groups, hospitals, charity foundations and trusts developing ATMPs.
The first objective set out in the new work programme is for CAT to “successfully respond to implementation of the provisions of Article 29 of Regulation (EC)1394/2007: assessment of products legally on the European Union (EU) market.”
To this end, it will: - conduct an analysis on number and kind of products legally on the EU market; - reflect on the criteria for Marketing Authorisation Application (MAA) assessment in compliance with Annex I, taking into account any flexibility built in the regulatory system; - adopt a proactive, open approach towards dialogue and exchange with potential applicants and national competent authorities; and - one year before the end of the transitional period, report to the European Commission and member states on the experience on the implementation of the provision of Article 29 of the ATMP Regulation.
The programme’s other objectives are to: - facilitate development of ATMPs and access to marketing authorization procedures; - promote the use of available regulatory procedures and introduce potential improvements; - explore the possibilities offered by the current regulatory framework when applied to ATMPs with a view to improving existing procedures and reflecting on alternatives; - contribute to fostering innovation; and - promote access and available to ATMP for EU patients.
CAT notes that it has already started work on some of the actions proposed in the programme, and that it will provide regular update reports as the work progresses.