EMA Seeks to Improve Regulatory Process for Advanced Therapy Medicines

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-03-2016 11:50


The European Medicines Agency (EMA) has published a report from a multi-stakeholder expert meeting held on May 27, 2016 to explore possible ways to foster the development of advanced therapy medicines (ATMPs) in Europe and expand patients’ access to these new treatments. ATMPs comprise gene therapies, tissue engineered products and somatic cell therapies.

ATMPs have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate. However, eight years since EU legislation on ATMPs entered into force in 2008, only five ATMPs are currently authorized. Although a total of seven ATMPs have received a marketing authorization since 2009, only five ATMPs are currently authorized. One marketing authorization for an ATMP was withdrawn by the marketing authorization holder and the authorization for another ATMP is currently suspended. At the same time clinical trials investigating ATMPs appear to represent a fast-growing field of interest, underlining the need for the EMA to better support innovation through a coherent and appropriate regulatory environment.

"We have organized this meeting with all relevant stakeholders to discuss concrete proposals on how we can nurture a regulatory environment that encourages development of ATMPs, safeguards public health and, ultimately, facilitates timely access for patients to much needed treatments," said EMA’s Executive Director Guido Rasi in his opening address.

The meeting brought together leading academics and researchers, representatives from patients’ and healthcare professionals’ organizations, small and large pharmaceutical companies, the investment community, incubators and consortium organizations, health technology assessment bodies, national competent authorities and the European Commission. In their discussions they focused on four key areas: facilitating research and development; optimizing regulatory processes for ATMPs; moving from hospital exemption to marketing authorization; and improving funding, investment and patient access.

Ideas and solutions proposed by the different stakeholders are summarized in the EMA report. Some of the recurring themes include the need for early interaction and guidance from regulators, more transparency and information sharing, greater harmonization between member states on various aspects of the ATMP legislative framework, and measures to tackle inequalities in patient access to ATMP treatments.

The EMA and its scientific committees, together with the European Commission and the national competent authorities, have started discussing the proposals made during the meeting. Concrete actions will be determined over the next few months and shared with stakeholders.

Source: European Medicines Agency


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