Objectives
It is the Interest Group’s objective to
- provide a Europe-wide networking platform for persons involved in the development, manufacturing, quality management and marketing authorisation of Advanced Therapy Medicinal Products (ATMP) by facilitating effective and efficient communication between sciences, industry, competent authorities and the pharmacopoeias.
- promote active discussion on the latest regulatory requirements for ATMP within the European Union, US and world wide.
- identify and address regulatory, scientific and technical issues and challenges, including training needs.
The ATMP Interest Group was established in 2017 by the ECA Foundation. Today, the ECA Foundation counts 8 Interest Groups. The ECA Foundation is an independent non-profit organisation. It was set up to support the Pharmaceutical Industry and Regulators in order to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances.
History
The Regulation (EC) No 1394/2007 provides the overall legal framework on ATMPs to be placed on the community market. Concomitantly, the ECA began evaluating the interest in courses and additional activities on cell based products in 2008. However, the initial interest in such events was limited at the time. The main reason for this may have been that many companies were still in the early phase of development. Nevertheless, to keep their members informed about the ongoing developments, the ECA continued to include ATMP topics in their newsletters and organised courses on GMP for ATMP every two years.
Meanwhile, due to promising results and increasing investments in the development of ATMP, a growing number of institutions and companies have reached the phase of clinical testing and GMP compliant manufacturing, as well as marketing authorisation. This development has resulted in a rising interest of ECA members on the topic of ATMP.
With the European Commission draft Guideline on GMP for ATMP, which was discussed intensely during the ECA ATMP workshop in April 2017, GMP requirements came to be more under scrutiny. During this event, we requested feedback of the participants on whether an ECA Working Group on ATMP would be of interest. Several participants expressed their interest. At the same time, within the European Qualified Person Association, the QPs involved in ATMPs started an initiative to discuss the subject (especially within the IMP Working Group).
To coordinate the increasing interests, ECA decided to establish a joint ATMP Interest Group.
AGORA – ATMP GMP Open Access Research Alliance
The ECA ATMP Interest Group took over the ATMP Toolbox from the AGORA Website.
Find out more on the history of the AGORA Project.
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