EMA Encourages Advanced Therapies

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The agency published a report on fostering the development of advanced therapy medicinal products.

On June 3, 2016, the European Medicines Agency published a report on ways to encourage the development of advanced therapy medicinal products (ATMP) in Europe. The report came out of a meeting held on May 27, 2016 that brought together representatives from academia, healthcare, patient organizations, pharmaceutical companies, health technology assessment bodies, and other stakeholders. The report summarizes the ideas and solutions proposed by these stakeholders.

The meeting focused on facilitating research and development; optimizing regulatory processes; moving from hospital exemption to marketing authorization; and improving funding and patient access. Regulatory guidance, legislative harmonization, and information sharing were some of the topics discussed.

"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 a press release.


According to EMA, only five ATMPs have been authorized since European Union legislation on ATMPs was enacted in 2008. “ATMPs comprise gene therapies, tissue engineered products, and somatic cell therapies. These medicines have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate,” EMA stated in the release. 

Source: EMA