Regulation and Guidelines

regulationAdvanced therapies comprise cell therapy, gene therapy and tissue engineering. For the most part, these are considered a special type of medicinal products. The only exception is the cell therapy which is considered as a cell transplant and not as a medicinal product when the cells are not subject to substantial manipulation and are used to carry out their normal function or essential functions.

Below, we show a selection of the main Spanish regulations (Acts, Royal Decrees and Orders) and European regulations (Directives and Regulations) which regulate both the basic, preclinical and clinical research in these kinds of products and their quality and manufacturing aspects and their marketing or clinic use. We also show a selection of guidelines and other documents of interest related to these issues as well as a list of the main websites where additional specialized information can be found.

Regulations Directive 2001/83/EC Directive 2003/63/EC Regulations 726/2004 Regulation 1394/2007 Directive 2009/120/EC Directive 2004/10/EC Regulation 668/2009 Diretive 2001/20/EC Directive 2003/94/EC Directive 2004/23/EC Directive 2006/17/EC Directive 2006/86/EC Ley 14/2007 Ley 29/2006 Ley 10/2013 Real Decreto 223/2004 Orden SCO/362/2008 Real Decreto 824/2010 Real Decreto 477/2014 Real Decreto 1015/2009 Real Decreto 577/2013 Real Decreto 782/2013 Real Decreto- Ley 9/2014 EMEA/CHMP/410869/2006 EMA/CAT/571134/2009 EMEA/CHMP/CPWP/83508/2009 EMA/CAT/CPWP/568181/2009 EMA/CAT/CPWP/573420/2009 CPMP/BWP/3088/99 EMA/CHMP/GTWP/671639/2008 CHMP/GTWP/212377/08 EMA/CAT/190186/2012 EMEA/CHMP/GTWP/125459/2006 EMA/CAT/GTWP/44236/2009 EMEA/CHMP/BMWP/101695/2006 EMA/CAT/CPWP/686637/2011 EMA/CAT/486831/2008/CORR. EMEA/149995/2008 EUDRALEX ENTR/F/2/SF/dn D(2009) 35810 Eudralex- Volume 4 CHMP/QWP/185401/2004 final EMA/CHMP/GTWP/60436/'07 EMA/781168/2013 Eudralex- Volume 9A ICH S6 ICH M3 (R2) ICH E1-E2FE2 ICH E3 ICH E6 ICH E7-E11 ICH Q7 ICH Q8 ICH Q9 ICH Q10 ICH M4 European Pharmacopeia CGMP FDA GCP Declaration of Helsinki