{"id":189,"date":"2014-11-06T13:32:52","date_gmt":"2014-11-06T12:32:52","guid":{"rendered":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/2014\/11\/06\/normativa\/"},"modified":"2026-10-02T14:05:32","modified_gmt":"2026-10-02T12:05:32","slug":"normativa","status":"publish","type":"post","link":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/2014\/11\/06\/normativa\/","title":{"rendered":"Normativa"},"content":{"rendered":"

\"laboratorios\"<\/p>\n

Las terapias avanzadas comprenden la terapia celular, la terapia g\u00e9nica y la ingenier\u00eda de tejidos, que en la mayor\u00eda de los casos son consideradas un tipo especial de medicamentos<\/strong>. Tan s\u00f3lo la terapia celular, cuando las c\u00e9lulas no se someten a manipulaciones sustanciales y se utilizan para que ejerzan su funci\u00f3n o funciones esenciales, se consideran trasplante<\/strong> de c\u00e9lulas y no medicamento.<\/p>\n

Aqu\u00ed presentamos una selecci\u00f3n de las principales normas espa\u00f1olas<\/strong> (leyes, reales decretos y \u00f3rdenes) y europeas<\/strong> (directivas y reglamentos) que regulan tanto la investigaci\u00f3n b\u00e1sica, precl\u00ednica y cl\u00ednica con este tipo de productos, como los aspectos de calidad y fabricaci\u00f3n de los mismos, y su comercializaci\u00f3n o uso cl\u00ednico.<\/p>\n

<\/p>\n

 <\/p>\n\n\n\n\n\n\n<\/colgroup>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PRINCIPALES NORMAS EUROPEAS Y ESPA\u00d1OLAS\u00a0<\/span><\/strong><\/span><\/td>\n<\/tr>\n
ACTUALIZACI\u00d3N: OCT.2026<\/span><\/td>\n<\/tr>\n
QUE APLICAN A MEDICAMENTOS DE TERAPIAS AVANZADAS<\/span><\/strong><\/span><\/em><\/span><\/td>\n<\/tr>\n
\u00a0<\/span><\/strong><\/span>NORMATIVA EUROPEA<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N B\u00c1SICA\/PRECL\u00cdNICA\u00a0\u00a0<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N CL\u00cdNICA<\/span><\/strong><\/span><\/td>\nCALIDAD\/FABRICACI\u00d3N\u00a0 O PROCESAMIENTO\u00a0 \u00a0 \u00a0<\/span><\/strong><\/span><\/td>\nCOMERCIALIZACI\u00d3N\/ USO CL\u00cdNICO<\/span><\/strong><\/span><\/td>\n<\/tr>\n
REGULATION (UE) 2024\/1938<\/span><\/a><\/td>\n<\/td>\n\u00a0<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2006\/17\/CE<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA (UE) 2017\/1572<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 1252\/2014<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTRIZ 2015\/C 95\/01<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTRIZ 2015\/C 95\/02<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 668\/2009<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 726\/2004<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 2019\/5<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\nX\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 536\/2014<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2001\/83\/CE\u00a0<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 1394\/2007<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 1901\/2006<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 469\/2009<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2001\/18\/CE<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 141\/2000<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO 847\/2000<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO DE EJECUCI\u00d3N 2022\/20<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\n<\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO DELEGADO 2017\/1569<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO (CE) 1234\/2008<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/td>\n X<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO (UE) 2021\/2282<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/td>\n X<\/span><\/strong><\/td>\n<\/tr>\n
NORMATIVA ESPA\u00d1OLA<\/span><\/strong><\/td>\nINVESTIGACI\u00d3N B\u00c1SICA\/PRECL\u00cdNICA<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N CL\u00cdNICA<\/span><\/strong><\/span><\/td>\nCALIDAD\/FABRICACI\u00d3N O PROCESAMIENTO\u00a0<\/span><\/strong><\/span><\/td>\nCOMERCIALIZACI\u00d3N\/ USO CL\u00cdNICO<\/span><\/strong><\/span><\/td>\n<\/tr>\n
LEY 14\/2007<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO-LEY 9\/2014<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 477\/2014<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 1090\/2015<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 577\/2013<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 1015\/2009<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO LEGISLATIVO 1\/2015\u00a0<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
LEY 41\/2002<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 824\/2010<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 1345\/2007<\/span><\/a><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 782\/2013<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
QUE APLICAN A TRASPLANTES DE C\u00c9LULAS<\/span><\/strong><\/em><\/span><\/td>\n<\/tr>\n
NORMATIVA EUROPEA<\/span><\/strong><\/td>\nINVESTIGACI\u00d3N B\u00c1SICA\/PRECL\u00cdNICA<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N CL\u00cdNICA<\/span><\/strong><\/span><\/td>\nCALIDAD\/FABRICACI\u00d3N O PROCESAMIENTO\u00a0<\/span><\/strong><\/span><\/td>\nCOMERCIALIZACI\u00d3N\/ USO CL\u00cdNICO<\/span><\/strong><\/span><\/td>\n<\/tr>\n
DIRECTIVA 2004\/23\/CE<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2015\/566<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2002\/98\/CE<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2006\/86\/CE<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2006\/17\/CE<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nDONANTE DE C\u00c9LULAS<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
DIRECTIVA 2001\/83\/CE<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
NORMATIVA ESPA\u00d1OLA<\/span><\/strong><\/td>\nINVESTIGACI\u00d3N B\u00c1SICA\/PRECL\u00cdNICA<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N CL\u00cdNICA<\/span><\/strong><\/span><\/td>\nCALIDAD\/FABRICACI\u00d3N O PROCESAMIENTO\u00a0<\/span><\/strong><\/span><\/td>\nCOMERCIALIZACI\u00d3N\/ USO CL\u00cdNICO<\/span><\/strong><\/span><\/td>\n<\/tr>\n
REAL DECRETO 1088\/2005<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO LEY 9\/2014<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\n<\/tr>\n
QUE APLICAN A PRODUCTOS SANITARIOS<\/span><\/strong><\/span><\/em><\/td>\n<\/tr>\n
NORMATIVA EUROPEA<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N B\u00c1SICA\/PRECL\u00cdNICA<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N CL\u00cdNICA<\/span><\/strong><\/span><\/td>\nCALIDAD\/FABRICACI\u00d3N O PROCESAMIENTO\u00a0<\/span><\/strong><\/span><\/td>\nCOMERCIALIZACI\u00d3N\/ USO CL\u00cdNICO<\/span><\/strong><\/span><\/td>\n<\/tr>\n
REGLAMENTO (UE) 2017\/745\u00a0<\/span><\/a><\/td>\n<\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO (UE) 2017\/746<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO (UE) 2023\/607<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n\u00a0<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n X\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REGLAMENTO (UE) 2024\/1860\u00a0<\/span><\/a><\/td>\n<\/td>\n<\/td>\nX<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n<\/tr>\n
NORMATIVA ESPA\u00d1OLA<\/span><\/strong><\/span><\/td>\nINVESTIGACI\u00d3N B\u00c1SICA\/PRECL\u00cdNICA<\/span><\/strong><\/td>\nINVESTIGACI\u00d3N CL\u00cdNICA<\/span><\/strong><\/td>\nCALIDAD\/FABRICACI\u00d3N O PROCESAMIENTO\u00a0<\/span><\/strong><\/td>\nCOMERCIALIZACI\u00d3N\/ USO CL\u00cdNICO<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 192\/2023<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\nX\u00a0<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 942\/2025<\/span><\/a><\/td>\n\u00a0<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\nX<\/span><\/strong><\/td>\n X<\/span><\/strong><\/td>\n<\/tr>\n
REAL DECRETO 437\/2002\u00a0<\/span><\/a><\/td>\n\u00a0<\/strong><\/span><\/td>\n\u00a0<\/strong><\/span><\/td>\nX<\/strong><\/span><\/td>\nX<\/strong><\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Las terapias avanzadas comprenden la terapia celular, la terapia g\u00e9nica y la ingenier\u00eda de tejidos, que en la mayor\u00eda de los casos son consideradas un tipo especial de medicamentos. Tan s\u00f3lo la terapia celular, cuando las c\u00e9lulas no se someten a manipulaciones sustanciales y se utilizan para que ejerzan su funci\u00f3n o funciones esenciales, se … Read More \u00abNormativa\u00bb<\/span> »<\/a><\/p>\n","protected":false},"author":2,"featured_media":140,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[10],"tags":[],"class_list":["post-189","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ct-investigadores"],"acf":[],"_links":{"self":[{"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/posts\/189","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/comments?post=189"}],"version-history":[{"count":30,"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/posts\/189\/revisions"}],"predecessor-version":[{"id":850,"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/posts\/189\/revisions\/850"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/media\/140"}],"wp:attachment":[{"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/media?parent=189"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/categories?post=189"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ws140.sspa.juntadeandalucia.es\/terapiasavanzadas\/index.php\/wp-json\/wp\/v2\/tags?post=189"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}