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. 2012 Mar;20(3):479-82.
doi: 10.1038/mt.2012.13.

Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive

Romaldas Maciulaitis  1 , Lucia D'Apote, Andrew Buchanan, Laura Pioppo, Christian K Schneider
Affiliations

Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive

Romaldas Maciulaitis et al. Mol Ther. 2012 Mar.
No abstract available

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Figures

Figure 1
Figure 1
Regulatory pathways for ATMPs in Europe. The usual sequence in which procedures are requested by applicants. Note that all procedures can be requested at any time during development. ATMP, advanced therapy medicinal product; CAT, Committee for Advanced Therapies; EMA, European Medicines Agency; SME, small and medium-sized enterprise.
Figure 2
Figure 2
The ATMP landscape in Europe 2004–2010. ATMP, advanced therapy medicinal product; CA, cancer; CBMP, cell-based medicinal product; DC, dendritic cell; GTMP, gene therapy medicinal product; HBSC, hematopoietic blood stem cell; MCRC, metastatic colorectal cancer; MSC, mesenchymal stem cell; SCTMP, somatic cell therapy medicinal product; SME, small and medium-sized enterprise; TEP, tissue-engineered product; Tx, transplantation.
Figure 3
Figure 3
Numbers of ATMPs and sponsors by country and type. ATMP, advanced therapy medicinal product; DC, dendritic cell; GTMP, gene therapy medicinal product; HBSC, hematopoietic blood stem cell; MSC, mesenchymal stem cell; TEP, tissue-engineered product.
See this image and copyright information in PMC

References

    1. European Commission (2009) Official Journal of the European Union 15.9.2009. L242/3-12; Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products.
    1. European Parliament and Council (2007) Official Journal of the European Union 10.12.2007. L324/121-137; Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.
    1. European Medicines Agency (2012). Certification procedure for SMEs < http://www.ema.europa.eu/ema/index.jsp?curl=pages/ regulation/general/ge... >.
    1. European Medicines Agency (2012) Scientific advice and protocol assistance < http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ ge... >.
    1. Schneider CK., and, Schäffner-Dallmann G. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe. Nat Rev Drug Discov. 2008;7:893–899. - PubMed