The focus of this GEN Market & Tech Analysis report is to frame the regulatory landscape of advanced therapy medicinal products (ATMP) in the European Union. The information and analysis presented in this report is based on the EMA/CAT-TRM Workshop held in conjunction with the World Conference of Regenerative Medicine (WCRM) held in Leipzig, Germany, October 23–25, 2013. The EMA/CAT-TRM Leipzig Collaborative Workshop was entitled "Advanced Therapy Medicinal Products: from Bench to Bedside"—regulatory path for translation of research to commercial medicinal products.
The focus of this workshop was to:
- describe the ATMP regulations in the EU
- describe pathways leading to market authorization
- discuss the hospital exemption
Highlights of this report:
- This report presents the most up-to-date information relating to the ATMP regulations as they govern the marketing authorization of cellular therapeutics [as well as tissue engineered and gene therapy products] across the European Union.
- Even though there is a common framework for marketing authorization (“approval”), there are many steps that need to take place at a “country-by-country” level.
- Reimbursement of ATMPs is also at the country-by-country level, and this brings in cost and complexity.
- In order for this field to be successful, engagement of the larger pharmaceutical and drug development entities is imperative for their expertise in navigating regulatory and commercial challenges plus the strength of their balance sheets.
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