ACI products are currently classified as tissue engineered technologies and are subject to the directive 2001/83/EC GMP guide. This guide replaces the EC/1394/2007 directive and will redefine and centralized the regulatory and scientific requirements for advanced therapies.
Under these regulations, therapies will gain European-wide approval for testing, provided that they meet the requirements within four years of application. Although this new law would simplify the process for some countries such as France and Spain, which previously had stricter regulations, this change will influence the entrance of new competitors.
Requirements must be met by 2012 for existing companies. These stringent requirements will ensure that ACI products will be of highest safety standards and will encourage the development of alternative cell-free based cartilage repair products, which generally are brought to market via the medical device regulatory route.
Although the ATMP regulation is intended to improve competitiveness in the European market, only one company, TiGenix, has gained approval. Tigenix has been showing great promise in cell-based regenerative therapy and will provide a benchmark for future market entrants. However, the market as a whole is still limited by the lack of reimbursement.
For more information on the ATMP, click on the link below:
For more information on TiGenix’s approved product, click on the link below: