{"id":4904,"date":"2024-09-06T11:48:12","date_gmt":"2024-09-06T16:48:12","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=4904"},"modified":"2026-01-27T13:26:52","modified_gmt":"2026-01-27T18:26:52","slug":"periodic-safety-report-ips-peru","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/periodic-safety-report-ips-peru\/","title":{"rendered":"Principales Consideraciones para la Elaboraci\u00f3n de Informes Peri\u00f3dicos de Seguridad de Productos Farmac\u00e9uticos en el Per\u00fa."},"content":{"rendered":"

Q.F. Ronald Erik Qui\u00f1onez Dextre
\n<\/span><\/i>Regulatory Affairs and Pharmacovigilance Analyst
\n<\/span><\/i>SCR Consultores Peru<\/span><\/i><\/p>\n

Como parte del desarrollo del sistema de farmacovigilancia en el Per\u00fa, desde la publicaci\u00f3n del\nReglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmac\u00e9uticos, Dispositivos\nM\u00e9dicos y Productos Sanitarios (Decreto Supremo No 016-2011-SA) se exige la elaboraci\u00f3n y presentaci\u00f3n\ndel Informe Peri\u00f3dico de Seguridad (IPS) para un producto farmac\u00e9utico a partir de la fecha de su\nautorizaci\u00f3n en este pa\u00eds, durante el tiempo de su comercializaci\u00f3n. En esta normativa se define por\nprimera vez a los Informes Peri\u00f3dicos de seguridad como un \u201cDocumento elaborado por el titular del\nregistro sanitario, que contiene informaci\u00f3n actualizada de seguridad de un producto farmac\u00e9utico o\ndispositivo m\u00e9dico, informaci\u00f3n de sospechas de reacciones adversas o incidentes adversos de las que se\nhaya tenido conocimiento en un periodo de referencia, as\u00ed como una evaluaci\u00f3n cient\u00edfica del balance\nbeneficio-riesgo\u201d.<\/p>\n

Posteriormente en el Per\u00fa, se public\u00f3 el Documento T\u00e9cnico: Manual de Buenas Pr\u00e1cticas de\nFarmacovigilancia a trav\u00e9s de la Resoluci\u00f3n Ministerial N\u00b01053-2020-MINSA el 13 de diciembre del 2020.\nEs en este documento que se plantean criterios m\u00e1s espec\u00edficos y definiciones m\u00e1s precisas sobre los\nInformes Peri\u00f3dicos de Seguridad, as\u00ed como un formato que describe a detalle la estructura para la\nelaboraci\u00f3n de este documento.<\/span><\/p>\n

En ambos documentos emitidos, el Informe Peri\u00f3dico de Seguridad tiene como objetivo realizar una evaluaci\u00f3n del balance beneficio\/riesgo del producto farmac\u00e9utico basado en toda la informaci\u00f3n acumulada sobre el producto desde el inicio de su desarrollo en el mundo.<\/span><\/p>\n

Para ello, es importante mencionar que seg\u00fan el Manual de Buenas Pr\u00e1cticas de Farmacovigilancia en el\nPer\u00fa, la elaboraci\u00f3n de este informe se realiza para todos los productos farmac\u00e9uticos, con excepci\u00f3n de\nmedicamentos herbarios, productos gal\u00e9nicos, productos homeop\u00e1ticos, productos diet\u00e9ticos y\nedulcorantes; pero se presenta a la autoridad solo en los siguientes casos:<\/span><\/p>\n

    \n
  1. a) Para los productos farmac\u00e9uticos que la Autoridad Nacional de Medicamentos (Direcci\u00f3n General\nde Medicamentos, Insumos y Drogas - DIGEMID) lo solicite.<\/span><\/li>\n
  2. b) Para los productos farmac\u00e9uticos que corresponda presentar el plan de gesti\u00f3n de riesgo para\nefectos del registro sanitario.<\/span><\/li>\n
  3. c) Para los productos farmac\u00e9uticos que la Autoridad Nacional de Medicamentos (Direcci\u00f3n General\nde Medicamentos, Insumos y Drogas -DIGEMID) solicite el plan de gesti\u00f3n de riesgos por motivos\nde seguridad.<\/span><\/li>\n<\/ol>\n

    Respecto al punto (a) se pueden mencionar algunas situaciones en las que la autoridad podr\u00eda solicitar la\npresentaci\u00f3n del Informe Peri\u00f3dico de Seguridad: riesgos graves o con mayor frecuencia detectados que\nrepercuten en salud p\u00fablica y por alertas mundiales relacionadas principalmente con el perfil de\nseguridad del producto farmac\u00e9utico registrado en el Per\u00fa.<\/span><\/p>\n

    Acerca de la periodicidad con la que se debe elaborar este documento, podemos hacer referencia a lo\nmencionado en el Manual de Buenas Pr\u00e1cticas de Farmacovigilancia:<\/span><\/p>\n

      \n
    1. a) Cada seis (06) meses durante los primeros dos (02) a\u00f1os, a partir de la fecha de autorizaci\u00f3n del\nproducto farmac\u00e9utico en el pa\u00eds.<\/span><\/li>\n
    2. b) Por los tres (03) a\u00f1os siguientes un reporte anual.<\/span><\/li>\n
    3. c) A partir del sexto a\u00f1o, un reporte cada cinco (05) a\u00f1os.<\/span><\/li>\n<\/ol>\n

      Cabe se\u00f1alar que si en caso el producto a\u00fan no se ha comercializado en el Per\u00fa, hay que tener en cuenta\nque se dispone de informaci\u00f3n global acumulada del producto, la cual nos puede servir de base para\niniciar con su elaboraci\u00f3n y de esa manera monitorear el balance beneficio\/riesgo del producto\nfarmac\u00e9utico.<\/p>\n

      Para su elaboraci\u00f3n se debe seguir la estructura presentada en el Anexo 1 del Manual de Buenas Pr\u00e1cticas\nde Farmacovigilancia del Per\u00fa, mencionado anteriormente. Es as\u00ed que el Informe Peri\u00f3dico de Seguridad\nconsta de las siguientes secciones:<\/span><\/p>\n

      Portada, resumen ejecutivo, \u00edndice, listado de tablas, listado de anexos, listado de abreviaturas,\nintroducci\u00f3n, situaci\u00f3n mundial de la autorizaci\u00f3n en el mercado, acciones adoptadas por las autoridades\nreguladoras o por el Titular de Registro sanitario\/Certificado de Registro Sanitario por razones de\nseguridad, cambios en la informaci\u00f3n de seguridad del producto, pacientes expuestos, presentaci\u00f3n de\ndatos de eventos adversos en forma resumida, resumen de hallazgos relevantes de ensayos cl\u00ednicos,\nhallazgos en estudios observacionales (no intervencionales), informaci\u00f3n de \u00faltimo momento, revisi\u00f3n de\nse\u00f1ales (nuevas, en curso o cerradas), evaluaci\u00f3n de se\u00f1ales y riesgos, evaluaci\u00f3n del beneficio, an\u00e1lisis\ndel balance beneficio-riesgo para las indicaciones aprobadas y por \u00faltimo, conclusiones.<\/span><\/p>\n

      Adicionalmente a la normativa peruana la elaboraci\u00f3n de los Informes Peri\u00f3dicos de Seguridad se puede\nllevar a cabo seg\u00fan la gu\u00eda de la Conferencia Internacional de Armonizaci\u00f3n (ICH E2C R2), la cual puede ser\nutilizada para otros pa\u00edses en Latinoam\u00e9rica<\/span><\/p>\n

      En resumen podemos mencionar que las distintas fuentes de informaci\u00f3n que nos sirven para elaborar este\ntipo de documentaci\u00f3n abarcar\u00edan: ensayos cl\u00ednicos, estudios post autorizaci\u00f3n, literatura cient\u00edfica,\nnotificaciones espont\u00e1neas, alertas de seguridad y base de datos relacionadas con la seguridad del\nproducto farmac\u00e9utico en evaluaci\u00f3n; adem\u00e1s de la informaci\u00f3n obtenida del propio sistema de\nfarmacovigilancia del Titular de Registro Sanitario\/Certificado de Registro Sanitario.<\/span><\/p>\n

      As\u00ed tambi\u00e9n para realizar el an\u00e1lisis del balance beneficio-riesgo es importante contar con la participaci\u00f3n\nde distintos profesionales con experiencia en los distintos puntos se\u00f1alados; esto a fin de tener un\npanorama m\u00e1s amplio de la informaci\u00f3n evaluada as\u00ed como el impacto que tendr\u00eda en la poblaci\u00f3n objetivo.<\/span><\/p>\n

      Todos los puntos detallados anteriormente se deben contemplar en el Informe Peri\u00f3dico de Seguridad y\nen caso no se cuente con informaci\u00f3n referente a alguno de los puntos, se debe justificar adecuadamente\nel motivo por el que no se cuenta con tal informaci\u00f3n.<\/span><\/p>\n

      Otro punto a tener en cuenta son algunas consideraciones generales referidas en el Manual de Buenas\nPr\u00e1cticas de Farmacovigilancia en el Per\u00fa para la elaboraci\u00f3n y\/o manejo de los Informes Peri\u00f3dicos de\nSeguridad, tales como:\u00a0<\/span><\/p>\n

        \n
      • Mantener un registro de todos los Informes Peri\u00f3dicos de Seguridad elaborados.<\/span><\/li>\n
      • Elaborar un solo Informe Peri\u00f3dico de Seguridad para las diferentes concentraciones de un mismo\nprincipio activo y\/o de asociaciones.<\/span><\/li>\n
      • Que el responsable de farmacovigilancia debe revisar y aprobar los Informes Peri\u00f3dicos de Seguridad si\nestos han sido elaborados por otra empresa.<\/span><\/li>\n
      • Finalmente, frente a una solicitud por parte de la autoridad para la presentaci\u00f3n de un Informe Peri\u00f3dico\nde Seguridad para un determinado producto farmac\u00e9utico, se cuenta con 90 d\u00edas para su presentaci\u00f3n\ny en general la presentaci\u00f3n puede ser 90 d\u00edas luego de la fecha de corte de informaci\u00f3n (FCI).<\/span><\/li>\n<\/ul>\n

        Finalmente, en relaci\u00f3n a los Informes Peri\u00f3dicos de Seguridad, debemos tener presente que los Titulares\nde Registro Sanitario\/Certificado del Registro Sanitario peruanos deben contar con avances y\/o resultados\nrespecto a la elaboraci\u00f3n de estos informes, m\u00e1s aun con la entrada en vigencia del Manual de Buenas\nPr\u00e1cticas de Farmacovigilancia de este pa\u00eds.<\/span><\/p>\n

        En conclusi\u00f3n, el desarrollo de los Informes Peri\u00f3dicos de Seguridad para los productos farmac\u00e9uticos que\nse comercializan en el Per\u00fa permitir\u00e1 que el Sistema de Farmacovigilancia de este pa\u00eds se robustezca y, a\nsu vez se genere un mayor sustento para la toma de decisiones respecto a la seguridad y uso adecuado de\nun producto farmac\u00e9utico por parte de la poblaci\u00f3n peruana; puesto que los resultados de la evaluaci\u00f3n\nbeneficio\/riesgo de un producto farmac\u00e9utico se manifestar\u00e1n principalmente en modificaciones de la\nficha t\u00e9cnica e inserto del mismo, manteniendo as\u00ed el dinamismo de su perfil de seguridad durante todo su\nciclo de vida; contribuyendo finalmente a la salud p\u00fablica del Per\u00fa.<\/span><\/p>\n



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

        Q.F. Ronald Erik Qui\u00f1onez Dextre Regulatory Affairs and Pharmacovigilance Analyst SCR Consulting Peru As part of the development of the pharmacovigilance system in Peru, since the publication of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products (Supreme Decree No. 016-2011-SA), the preparation and presentation of the […]<\/p>\n","protected":false},"author":4,"featured_media":4924,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,89,87],"tags":[],"class_list":["post-4904","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-pharmacovigilance-analyst","category-regulatory-affairs"],"yoast_head":"\nPSR (IPS) in Peru: DIGEMID Requirements & Submission<\/title>\n<meta name=\"description\" content=\"A practical guide to Periodic Safety Reports (IPS) in Peru: when 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