Ongoing developments in the field of ATMP

In the last months, Advanced Therapy Medicinal Products (ATMP), the relating regulations and the possibilities for an increasing development have been more and more in the focus of the regulators at EMA and in national authorities. But organisations and companies involved in research, development or manufacturing of Advanced Therapy Medicinal Products are also increasingly involved in the Europe-wide discussion. This is visible through the ongoing discussions about the draft guideline on GMP for ATMP but also through the results of the EMA stakeholder meeting in May 2016. The main discussed topics there were:

  • Facilitating research and development
  • Optimising regulatory processes for ATMPs
  • Moving from hospital exemption to marketing authorisation
  • Improving funding, investment and patient access

In February, the EMA published the news entitled "Advanced therapy medicines: towards increased development and patient access" with the following content about that:

"Follow-up activities addressing stakeholder need
The European Medicines Agency (EMA) has published today a set of ideas to better support development and expand patients' access to high quality, safe and effective advanced therapy medicinal products (ATMPs).

The existing efforts in the area of ATMPs are enriched by these ideas that were developed following a multi-stakeholder expert meeting on advanced therapy medicines organised in May 2016, at which EMA, the European Commission and representatives from the national competent authorities explored together with stakeholders ways to encourage innovation, research and development.

ATMPs, comprising gene therapies, tissue engineered products and somatic cell therapies, have the potential to reshape the treatment of a wide range of conditions. These therapies are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate."

This news should be read in context with the summary on "Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs' development and patient access in Europe" and the paper with the "Issues identified by stakeholders: follow-up from EMA's ATMP workshop".

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