{"id":17325,"date":"2026-10-28T15:50:33","date_gmt":"2026-10-28T20:50:33","guid":{"rendered":"https:\/\/omcabogados.com.pe\/?p=17325"},"modified":"2026-10-28T18:12:18","modified_gmt":"2026-10-28T23:12:18","slug":"digemid-inspeccion-y-control-sanitario-internacional-de-los-medicamentos-en-el-mercado-peruano","status":"publish","type":"post","link":"https:\/\/omcabogados.com.pe\/es\/digemid-inspeccion-y-control-sanitario-internacional-de-los-medicamentos-en-el-mercado-peruano\/","title":{"rendered":"DIGEMID: Inspecci\u00f3n y control sanitario internacional de los medicamentos en el mercado peruano"},"content":{"rendered":"<p>La <strong><a href=\"https:\/\/www.digemid.minsa.gob.pe\">Direcci\u00f3n General de Medicamentos, Insumos y Drogas (DIGEMID)<\/a><\/strong> por encargo del <strong><a href=\"https:\/\/www.digemid.minsa.gob.pe\">MINSA (Ministerio de Salud)<\/a><\/strong> realiz\u00f3 una inspecci\u00f3n internacional a los laboratorios que comercializan medicamentos en el mercado peruano y que cuentan con su respectivo certificado regulatorio.<\/p>\n<p>El proceder de las autoridades de <strong><a href=\"https:\/\/www.digemid.minsa.gob.pe\">DIGEMID<\/a><\/strong> obedece a su nueva estrategia para el control y cumplimiento de las Buenas Pr\u00e1cticas de Manufactura (BPM), por parte de los laboratorios farmac\u00e9uticos extranjeros que comercializan f\u00e1rmacos en el Per\u00fa.<\/p>\n<p>93 laboratorios farmac\u00e9uticos en pa\u00edses de Asia, Europa y Am\u00e9rica han sido inspeccionados desde noviembre 2025 a la fecha.<\/p>\n<h2><u>Control regulatorio y de BPM para los medicamentos en el Per\u00fa<\/u><\/h2>\n<p>24 inspectores especializados de <a href=\"https:\/\/www.digemid.minsa.gob.pe\"><strong>DIGEMID<\/strong><\/a> visitaron laboratorios en <a href=\"http:\/\/www.argentina.gob.ar\"><strong>Argentina<\/strong><\/a>, <strong><a href=\"http:\/\/www.presidencia.gov.co\">Colombia<\/a><\/strong> e <strong><a href=\"http:\/\/www.india.gov.in\">India<\/a><\/strong>. Su misi\u00f3n fue verificar las condiciones de origen de los f\u00e1rmacos que abastecen al pa\u00eds. La nueva estrategia contempla iniciar el control regulatorio de los medicamentos en su mismo lugar de fabricaci\u00f3n e identificar los posibles riesgos sanitarios. El objetivo es evitar que los productos farmac\u00e9uticos que incumplan con los BPM lleguen a la poblaci\u00f3n.<\/p>\n<h2><u>Otorgamiento de certificados y alineamiento con las pol\u00edticas internacionales<\/u><\/h2>\n<p>Uno de los prop\u00f3sitos es alinearse a las pol\u00edticas internacionales y contribuir con el cierre de las brechas identificadas por <a href=\"http:\/\/www.who.int\/tools\/global-benchmarking-tools\"><strong>The Global Benchmarking Tool (GBT)<\/strong><\/a>, la herramienta de la <a href=\"https:\/\/www.who.int\/es\/home\"><strong>Organizaci\u00f3n Mundial de la Salud (OMS)<\/strong><\/a> que mide la fortaleza y el desempe\u00f1o de los sistemas regulatorios nacionales para los productos m\u00e9dicos.<\/p>\n<p>Desde noviembre 2025, han sido evaluados un total de 93 laboratorios farmac\u00e9uticos evidenciando el rigor t\u00e9cnico e independencia de las evaluaciones. La certificaci\u00f3n se otorga en funci\u00f3n del cumplimiento efectivo de los requisitos. Los resultados obtenidos de la evaluaci\u00f3n son los siguientes:<\/p>\n<ul>\n<li>36 laboratorios obtuvieron la certificaci\u00f3n de BPM.<\/li>\n<li>7 laboratorios alcanzaron una certificaci\u00f3n parcial.<\/li>\n<li>32 laboratorios no recibieron la certificaci\u00f3n por incumplimiento t\u00e9cnico.<\/li>\n<li>18 laboratorios desistieron del proceso.<\/li>\n<\/ul>\n<p>Si le gust\u00f3 esta nota, guarde la informaci\u00f3n y comp\u00e1rtala con alg\u00fan colega que le pueda servir. OMC Abogados &amp; Consultores se encuentra a su entera disposici\u00f3n si necesita asesor\u00eda sobre asuntos regulatorios o tr\u00e1mites ante <strong><a href=\"https:\/\/www.digemid.minsa.gob.pe\">DIGEMID,<\/a><\/strong> solo ingrese en el link: <a href=\"https:\/\/omcabogados.com.pe\/es\/consultas-legales-peru-latinoamerica\/\">https:\/\/omcabogados.com.pe\/es\/consultas-legales-peru-latinoamerica\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Direcci\u00f3n General de Medicamentos, Insumos y Drogas (DIGEMID) por encargo del MINSA (Ministerio de Salud) realiz\u00f3 una inspecci\u00f3n internacional a los laboratorios que comercializan medicamentos en el mercado peruano y que cuentan con su respectivo certificado regulatorio. El proceder de las autoridades de DIGEMID obedece a su nueva estrategia para el control y cumplimiento [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":17327,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_vp_format_video_url":"","_vp_image_focal_point":[],"_vp_custom_popup_image":0,"_vp_format_audio_url":"","_vp_custom_thumbnail":0,"_vp_custom_thumbnail_focal_point":[],"_vp_hover_thumbnail":0,"_vp_hover_thumbnail_focal_point":[],"footnotes":""},"categories":[45],"tags":[210,162,164,211],"class_list":["post-17325","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notas-de-prensa","tag-bpm","tag-digemid","tag-minsa","tag-oms"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>DIGEMID: Inspecci\u00f3n y control sanitario internacional de los medicamentos en el mercado peruano - 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