ECA Foundation establishes new Interest Group on ATMPs
Advanced Therapy Medicinal Products (ATMP) are a new emerging class of innovative biopharmaceutical medicines, summarizing gene therapy, somatic cell therapy and tissue-engineered products. ATMPs are regarded as medicinal products and must therefore comply with cGMP and the current EU Medicines legislation The complex development, short shelf life and therefore often very short time for preparing of the ATMP necessitates for these products to deviate from the classic GMP requirements. To accommodate the special concerns for such products, the European Commission has published "New Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products". This new document stipulates "ATMP manufacturers should comply with these Guidelines no later than 22 May 2018".
To support their members with information and guidance, the ECA has founded a new ATMP Interest Group with the following objectives:
- 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 academia, industry, competent authorities and the pharmacopoeias.
- Promote active discussion on the latest regulatory requirements for ATMP within the European Union, the US and worldwide.
- Identify and address regulatory, scientific and technical issues and challenges, including training needs.
When the ECA started with the inauguration of a new ATMP Group a contact was established with the AGORA Group. From 01 September 2013 until 31 October 2015, the European Commission had funded the AGORA Project (No. 602366) to propose an academic & industrial partnership to facilitate safe and effective delivery of new advanced therapy medicines within the framework of the relevant EU regulations. To avoid the loss of the collected AGORA knowledge and to get the possibility of ongoing improvement of this information, ECA and AGORA have decided to transfer the content of the AGORA website (especially the AGORA toolbox) to the new ECA ATMP Interest group's website. Furthermore, all AGORA Members will have the opportunity to become a member of the new ATMP Group.
To find out more please visit the new ATMP Interest Group Website.