{"id":122,"date":"2017-02-28T20:37:52","date_gmt":"2017-02-28T20:37:52","guid":{"rendered":"https:\/\/centro-eclin.com.ar\/?page_id=122"},"modified":"2021-06-28T13:41:37","modified_gmt":"2021-06-28T13:41:37","slug":"normativas-2","status":"publish","type":"page","link":"https:\/\/centro-eclin.com.ar\/?page_id=122","title":{"rendered":"Normas"},"content":{"rendered":"\n
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INTERNACIONAL<\/h3>\n\n\n\n

Alta Variabilidad Canad\u00e1 2015.docx<\/a><\/p>\n\n\n\n

Asociaciones EMA 2015<\/a><\/p>\n\n\n\n

Asociaciones OMS Anexo 5 2005.pdf<\/a><\/p>\n\n\n\n

BCS I y III Test de Disn y Especif FDA 2015.pdf<\/a><\/p>\n\n\n\n

BCS SUPAC Disn FDA 1997.pdf<\/a><\/p>\n\n\n\n

BCS y Biowaivers Canad\u00e1 2014.pdf<\/a><\/p>\n\n\n\n

BCS y Biowaivers Candidatos ANVISA 2014.pdf<\/a><\/p>\n\n\n\n

BCS y Biowaivers FDA 2000.pdf<\/a><\/p>\n\n\n\n

BCS y Biowaivers FDA-ICH 2021<\/a><\/p>\n\n\n\n

BCS y Biowaivers WHO Inf 49 2015<\/a><\/p>\n\n\n\n

BD Generalidades FDA 2019<\/a><\/p>\n\n\n\n

BE ANVISA Lista 1 19ag2020 <\/a><\/p>\n\n\n\n

BE ANVISA Lista 2 – 6mar17<\/a><\/p>\n\n\n\n

BE ANVISA Lista 3 9oct2020 <\/a><\/p>\n\n\n\n

BE Bioanalyt Validation FDA 2013.pdf<\/a><\/p>\n\n\n\n

BE Canad\u00e1 1992.pdf<\/a><\/p>\n\n\n\n

BE Canada Guidance BDBE Studies 2018<\/a><\/p>\n\n\n\n

BE Canad\u00e1 standards 2012.pdf<\/a><\/p>\n\n\n\n

BE EMA 2010.pdf<\/a><\/p>\n\n\n\n

BE EMA Q&A 2015.pdf<\/a><\/p>\n\n\n\n

BE Food-Effect FDA 2019<\/a><\/p>\n\n\n\n

BE Generalidades FDA 2014<\/a><\/p>\n\n\n\n

BE Generics Jap\u00f3n 2012<\/a><\/p>\n\n\n\n

BE Jap\u00f3n Standards 2012 <\/a><\/p>\n\n\n\n

BE Lib Modif EMA 2015<\/a><\/p>\n\n\n\n

BE Multisource WHO Inf 49 2015<\/a><\/p>\n\n\n\n

BE Nasal FDA 2003<\/a><\/p>\n\n\n\n

BE Pk endpoints FDA 2013<\/a><\/p>\n\n\n\n

BE Red PARF 2008<\/a><\/p>\n\n\n\n

BE Stat FDA 2001<\/a><\/p>\n\n\n\n

BE Stat FDA 2003<\/a><\/p>\n\n\n\n

BE Topical y Dermat FDA 1995<\/a><\/p>\n\n\n\n

GMP WHO Inf 48 2014<\/a><\/p>\n\n\n\n

Helsinki 2008<\/a><\/p>\n\n\n\n

Helsinki 2013<\/a><\/p>\n\n\n\n

Ingesta diaria Mercosur<\/a><\/p>\n\n\n\n

Ingesta diaria WHO<\/a><\/p>\n\n\n\n

Polimorfismo FDA 2007<\/a><\/p>\n\n\n\n

Prod Referencia Canad\u00e1 1995<\/a><\/p>\n\n\n\n

Prod Referencia WHO Inf 49 2015<\/a><\/p>\n\n\n\n

Registro – Gu\u00eda ICH 2007<\/a><\/p>\n\n\n\n

SUPAC-Equipment FDA.pdf<\/a><\/p>\n\n\n\n

SUPAC-IR FDA<\/a><\/p>\n\n\n\n

SUPAC-IR-MR FDA<\/a><\/p>\n\n\n\n

SUPAC-MR FDA<\/a><\/p>\n\n\n\n

SUPAC-SS FDA<\/a><\/p>\n<\/div>\n\n\n\n

\n

NACIONAL<\/h3>\n\n\n\n

1994_Res. 282 Min Salud (Categorizaci\u00f3n centros).pdf<\/a><\/p>\n\n\n\n

1999_Disp. 3185_ANMAT (1er Disp BE y Riesgo Sanitario).doc<\/a><\/p>\n\n\n\n

2000_Res. 229_SPRS (BE Piridostigmina – Miastenia gravis).doc<\/a><\/p>\n\n\n\n

2001_Disp. 3311_ANMAT (BE AHIV).doc<\/a><\/p>\n\n\n\n

2001_Res. 40_SPRS (BE AHIV).doc<\/a><\/p>\n\n\n\n

2002_Disp. 1277_ANMAT (Prorrog. BE AHIV).doc<\/a><\/p>\n\n\n\n

2002_Disp. 2807_SP (BE Isotretino\u00edna y varios Prod Ref).doc<\/a><\/p>\n\n\n\n

2002_Disp. 2814_SP (Esp. Medic. que no requieren BE).doc<\/a><\/p>\n\n\n\n

2002_Disp. 4290_ANMAT (Varios Prod Ref).doc<\/a><\/p>\n\n\n\n

2002_Disp. 5318_ANMAT (Prod Ref Fenito\u00edna).doc<\/a><\/p>\n\n\n\n

2002_Disp. 7062_ANMAT (Prod Ref Teofilina).doc<\/a><\/p>\n\n\n\n

2003_Res. 19_SPRRS (Plazos BE AHIV)<\/a><\/p>\n\n\n\n

2003_Res. 25_SPRRS (Plazos BE AHIV)<\/a><\/p>\n\n\n\n

2003_Res. 46_SPRRS (Cronograma BE AHIV)<\/a><\/p>\n\n\n\n

2003_Res. 60_MS (ANMAT define Prod Ref)<\/a><\/p>\n\n\n\n

2004_Disp. 4218_ANMAT (Prod Ref Lamivudina)<\/a><\/p>\n\n\n\n

2005_Disp. 2749_ANMAT (Prod Ref Didanosina)<\/a><\/p>\n\n\n\n

2005_Disp. 4844_SP (BPL Etapa Anal\u00edtica BE)<\/a><\/p>\n\n\n\n

2006_Disp. 5040_ANMAT (BPBDBE excepto Anexo I derogado)<\/a><\/p>\n\n\n\n

2007_Disp. 1746_ANMAT (Reemplaza al Anexo I de la Disp 5040 )<\/a><\/p>\n\n\n\n

2007_Disp. 2446_ANMAT (BE Micof-Sero-Evero-Tacro)<\/a><\/p>\n\n\n\n

2008_Disp. 4173_ANMAT (Asociaciones)<\/a><\/p>\n\n\n\n

2008_Disp. 4691_MS y ANMAT (Desig. Miembros Com. Ases. en BD-BE)<\/a><\/p>\n\n\n\n

2009_Disp. 556_ANMAT (Cambios Post. Reg. BE-SUPAC)<\/a><\/p>\n\n\n\n

2009_Disp. 758_ANMAT (Bioexenci\u00f3n de S\u00f3lidos Orales LI)<\/a><\/p>\n\n\n\n

2010_Disp. 5316_MS y ANMAT (Incorp. Regl. Mercosur BP Transporte)<\/a><\/p>\n\n\n\n

2010_Disp.3113_ANMAT (BE Lamotrigina y Topiramato)<\/a><\/p>\n\n\n\n

2010-Disp. 6677 ANMAT (BPC)<\/a><\/p>\n\n\n\n

2011_Res. 23 GMC (Mercosur Eventos Adversos)<\/a><\/p>\n\n\n\n

2011_Res. 1480_MS (Gu\u00eda Investig. Seres Humanos-Deroga a 1490 y 102)<\/a><\/p>\n\n\n\n

2011-Circ. 001 ANMAT (\u00c1mbito en DEM para Proy Invest)<\/a><\/p>\n\n\n\n

2011-Circ. 003 ANMAT (Base de Datos de Estudios de FC)<\/a><\/p>\n\n\n\n

2012_Disp. 1263_ANMAT  (Lote para BE)<\/a><\/p>\n\n\n\n

2012_Disp. 3586_ ANMAT (Gesti\u00f3n electr\u00f3nica Est Farm Cl\u00edn)<\/a><\/p>\n\n\n\n

2012_Disp. 4132_ANMAT (BE para todas las concentraciones o Bioexenci\u00f3n)<\/a><\/p>\n\n\n\n

2012_Disp. 4133_ANMAT (S\u00f3lo resultados IC 80-125)<\/a><\/p>\n\n\n\n

2012_Disp. 4326_ ANMAT (Criterio riesgo sanitario para exigir BE)<\/a><\/p>\n\n\n\n

2012_Disp. 5358 ANMAT (farmacovigilancia)<\/a><\/p>\n\n\n\n

2012-Circ. 009 ANMAT (Registro Nacional de Investigac. en Salud)<\/a><\/p>\n\n\n\n

2013_Disp. 1918_ANMAT (Criterios para establecer Prod Ref)<\/a><\/p>\n\n\n\n

2013_Disp. 2434_ANMAT (Requisitos p BE del exterior)<\/a><\/p>\n\n\n\n

2013_Disp. 4394_ANMAT (BPL Centros Bioanal\u00edticos p BE)<\/a><\/p>\n\n\n\n

2013-Circ. 001 ANMAT (Dossier para iniciar Solicitud Autorizac. Est. BE)<\/a><\/p>\n\n\n\n

2013-Circ. 004 ANMAT (Prospecto de informaci\u00f3n p el paciente)<\/a><\/p>\n\n\n\n

2013-Circ. 009 ANMAT (Nuevo Nombre de los Deptos)<\/a><\/p>\n\n\n\n

2013-Circ. 020 ANMAT (Farmaco de INAME evaluar\u00e1 Exp x Disp 758-09)<\/a><\/p>\n\n\n\n

2014-Circ. 003 ANMAT (Para Reinscripci\u00f3n Prospecto-BE-PGR)<\/a><\/p>\n\n\n\n

2016_Disp. 11247_ANMAT (Prod Ref 4788)<\/a><\/p>\n\n\n\n

2016_Disp. 12704_ANMAT (Scaling)<\/a><\/p>\n\n\n\n

2016_Memo ANMAT (Cambios Post Reg 4788)<\/a><\/p>\n\n\n\n

2016-Circ. 011 ANMAT (BE para Registro y 1er Lote)<\/a><\/p>\n\n\n\n

2017_Disp. 1474 SsPRyF (Reglam Comit\u00e9 Nac \u00c9tica en Investig ANEXO)<\/a><\/p>\n\n\n\n

2017_Disp. 4008 ANMAT (Estudios de Farmacolog\u00eda Cl\u00ednica)<\/a><\/p>\n\n\n\n

2017_Disp. 8255 ANMAT (BE- Ptos Referencia)<\/a><\/p>\n\n\n\n

2017_Disp. 8256 ANMAT (BE ext-Antig\u00fcedad)<\/a><\/p>\n\n\n\n

2017_Disp. 8259 ANMAT (Levotiroxina Prod ref T4 Montpellier)<\/a><\/p>\n\n\n\n

2017_Disp. 8262 ANMAT (Levotiroxina Prod ref Glaxo)<\/a><\/p>\n\n\n\n

2017_Disp. 8870 (IFAs q no se absorben)<\/a><\/p>\n\n\n\n

2017_Disp. 9222 ANMAT (BE 9 drogas)<\/a><\/p>\n\n\n\n

2018_Disp. 2089 MSYDS (evid comerc)<\/a><\/p>\n\n\n\n

2018_Disp. 8398 ANMAT (IFAs 1ra vez)<\/a><\/p>\n\n\n\n

2019_Circular 1719 ANMAT (IFAs en BE – Requisitos REM-NFF-NCC)<\/a><\/p>\n\n\n\n

2019_Circular 1720 ANMAT (BE 1 fabricante y 2 registros)<\/a><\/p>\n\n\n\n

2019_Circular 70772 ANMAT<\/a><\/p>\n\n\n\n

2019_Circular ANMAT (GEM)<\/a><\/p>\n\n\n\n

2019_Disp. 271 ANMAT (Programa BDBE e Intercambiabilidad)<\/a><\/p>\n\n\n\n

2019_Disp. 3289_ANMAT (Autoriz BE y Rdos) Anexo I<\/a><\/p>\n\n\n\n

2019_Disp. 3289_ANMAT (Autoriz BE y Rdos) Anexo II<\/a><\/p>\n\n\n\n

2019_Disp. 3289_ANMAT (Autoriz BE y Rdos, deroga Disp 4010\/17)<\/a><\/p>\n\n\n\n

2019_Disp. 4620_ANMAT (Reg Art 3ro-Deroga 513-19) Anexo 1<\/a><\/p>\n\n\n\n

2019_Disp. 4620_ANMAT (Reg Art 3ro-Deroga 513-19)<\/a><\/p>\n\n\n\n

2019_Disp. 4621_ANMAT (Reg Art 4to) Anexo 1<\/a><\/p>\n\n\n\n

2019_Disp. 4621_ANMAT (Reg Art 4to)<\/a><\/p>\n\n\n\n

2019_Disp. 5068 ANMAT (Proced. Bioexenciones) Anexo 1<\/a><\/p>\n\n\n\n

2019_Disp. 5068 ANMAT (Proced. Bioexenciones) Anexo 2<\/a><\/p>\n\n\n\n

2019_Disp. 5068 ANMAT (Proced. Bioexenciones) Anexo 3<\/a><\/p>\n\n\n\n

2019_Disp. 5068 ANMAT (Proced. Bioexenciones) Anexo 4<\/a><\/p>\n\n\n\n

2019_Disp. 5068 ANMAT (Proced. Bioexenciones) Anexo 5<\/a><\/p>\n\n\n\n

2019_Disp. 5068 ANMAT (Proced. Bioexenciones)<\/a><\/p>\n\n\n\n

2019_Disp. 9707 ANMAT (1er lote)<\/a><\/p>\n\n\n\n

2019_Disp. 9707 ANMAT (1er lote) Anexo 1<\/a><\/p>\n\n\n\n

2019_Disp. 9708 ANMAT (BE in vitro-deroga la 4788)<\/a><\/p>\n\n\n\n

2019_Disp. 9708 ANMAT (BE in vitro) Anexo 1<\/a><\/p>\n\n\n\n

2019_Disp. 9709 ANMAT (Biol\u00f3g Autoriz Comerc)<\/a><\/p>\n\n\n\n

2019_Disp. 9709 ANMAT (Biol\u00f3g Autoriz Comerc) Anexo 1<\/a><\/p>\n\n\n\n

2019_Disp. 9929 ANMAT (Estudios Fase I-sustituye art 11 de 4008-17)<\/a><\/p>\n\n\n\n

2019_Disp. 9944 ANMAT (Centros Cl\u00ednicos BE)<\/a><\/p>\n\n\n\n

2019_Disp. 9944 ANMAT (Centros Cl\u00ednicos BE) Anexo 1<\/a><\/p>\n\n\n\n

2019_Disp. 9944 ANMAT (Centros Cl\u00ednicos BE) Anexo 2<\/a><\/p>\n\n\n\n

2020 Disp. ANMAT_4540 (Comisi\u00f3n BD-BE)<\/a><\/p>\n\n\n\n

2020_Disp. ANMAT_4827 (Prod Ref 8398-deroga ibrutinib)<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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

INTERNACIONAL Alta Variabilidad Canad\u00e1 2015.docx Asociaciones EMA 2015 Asociaciones OMS Anexo 5 2005.pdf BCS I y III Test de Disn y Especif FDA 2015.pdf BCS SUPAC Disn FDA 1997.pdf BCS y Biowaivers Canad\u00e1 2014.pdf BCS y Biowaivers Candidatos ANVISA 2014.pdf BCS y Biowaivers FDA 2000.pdf BCS y Biowaivers FDA-ICH 2021 BCS y Biowaivers WHO Inf 49 2015 BD Generalidades FDA 2019 BE ANVISA Lista 1 […]<\/p>\n","protected":false},"author":1,"featured_media":219,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=\/wp\/v2\/pages\/122"}],"collection":[{"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=122"}],"version-history":[{"count":109,"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=\/wp\/v2\/pages\/122\/revisions"}],"predecessor-version":[{"id":544,"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=\/wp\/v2\/pages\/122\/revisions\/544"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=\/wp\/v2\/media\/219"}],"wp:attachment":[{"href":"https:\/\/centro-eclin.com.ar\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=122"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}