{"id":4668,"date":"2024-08-29T00:39:15","date_gmt":"2024-08-29T05:39:15","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=4668"},"modified":"2026-01-27T11:23:38","modified_gmt":"2026-01-27T16:23:38","slug":"safety-efficacy-pharmaceutical-registration-peru-digemid","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/safety-efficacy-pharmaceutical-registration-peru-digemid\/","title":{"rendered":"Principales Aspectos a Considerar en el Sustento de la Seguridad y Eficacia para el Registro Sanitario de las Especialidades Farmac\u00e9uticas en Per\u00fa"},"content":{"rendered":"

Q.F. Ronald Erik Qui\u00f1onez Dextre
\n<\/i><\/b>Regulatory Affairs, Safety and Efficacy Analyst
\n<\/i><\/b>SCR Consultores Peru<\/i><\/b><\/p>\n

Con la promulgaci\u00f3n en el a\u00f1o 2009 de la Ley N\u00b0 29459: \u201cLey de los Productos Farmac\u00e9uticos,\nDispositivos M\u00e9dicos y Productos Sanitarios\u201d;<\/b> y posteriormente con la aprobaci\u00f3n del \u201cReglamento\npara el Registro, Control y Vigilancia Sanitaria de Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos\ny Productos Sanitarios\u201d <\/b>(aprobado a trav\u00e9s del Decreto Supremo N\u00b0 016-2011-SA) en el a\u00f1o 2011, se\nestablecieron nuevas directrices, normas, criterios y exigencias b\u00e1sicas para que se garantice que los\nproductos farmac\u00e9uticos, dispositivos m\u00e9dicos y productos sanitarios a comercializarse en el Per\u00fa, sean\neficaces, seguros y de calidad. As\u00ed mismo, los principios de seguridad y eficacia est\u00e1n sustentados a\ntrav\u00e9s de estudios precl\u00ednicos y cl\u00ednicos.\n\nDentro de los m\u00faltiples requisitos regulatorios que exige la normativa peruana para el registro sanitario de\nespecialidades farmac\u00e9uticas y que se encuentran plasmadas en el Decreto Supremo No 016-2011-SA,\nes primordial la presentaci\u00f3n de informaci\u00f3n t\u00e9cnica o estudios que sustenten la eficacia y seguridad de la especialidad farmac\u00e9utica a registrar.<\/p>\n

Previo a la presentaci\u00f3n de las consideraciones que se deben tener en cuenta en la sustentaci\u00f3n de\nla seguridad y eficacia de las especialidades farmac\u00e9uticas, es importante tener presente los\nsiguientes conceptos, tomados de la Ley N\u00b0 29459:
\nPrincipio de seguridad:<\/b> Garant\u00eda de que el producto a utilizar, en las condiciones normales de uso y duraci\u00f3n de\ntratamiento, pueda ser utilizado con los efectos previstos, sustentados en estudios precl\u00ednicos y cl\u00ednicos, sin presentar\nriesgo para la salud.
\nPrincipio de eficacia<\/b>: Beneficio en el tratamiento, prevenci\u00f3n y diagn\u00f3stico de las personas, expresado en el valor\nterap\u00e9utico y necesidad del producto para preservar o mejorar la salud, que se encuentra sustentado en\nestudios precl\u00ednicos y ensayos cl\u00ednicos que se ajustan a exigencias normativas y avances en el conocimiento.
\nUna de las actividades primordiales que se deben realizar al iniciar la revisi\u00f3n de un dossier de una\nespecialidad farmac\u00e9utica, es identificar a que categor\u00eda pertenece esta. En Per\u00fa, existen tres\ncategor\u00edas y teniendo en cuenta ello, se puede determinar qu\u00e9 informaci\u00f3n se debe presentar a fin de\nsustentar la seguridad y eficacia del producto farmac\u00e9utico que se quiere registrar. Para brindar un\nmejor detalle a lo mencionado, se presenta el siguiente cuadro:<\/p>\n\n\n\n\n
Categorias<\/strong><\/td>\nDefinici\u00f3n<\/strong><\/td>\nCondiciones<\/strong><\/td>\nSustento de seguridad y eficacia<\/strong><\/td>\n<\/tr>\n
Categoria 1<\/strong><\/td>\nE s p e c i a l i d a d e s\nfarmac\u00e9uticas cuyos\ni n g r e d i e n t e s\nfarmac\u00e9uticos activos\no asociaciones se\nencuentran en el\nPetitorio Nacional\n\u00da n i c o d e\nM e d i c a m e n t o s\nEsenciales (PNUME).<\/td>\n<\/p>\n\n\n\n\n
Forma farmac\u00e9utica,\ncantidad del IFA y v\u00eda\nde administraci\u00f3n igual\na la presente en el\nPNUME.<\/p>\n

\u00a0<\/td>\n<\/tr>\n

Forma farmac\u00e9utica,\ncantidad del IFA y v\u00eda\nde administraci\u00f3n igual\na la presente en el\nPNUME.<\/p>\n

\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n

<\/p>\n\n\n\n\n\n
No es necesario presentar sustento de seguridad y\neficacia.\nLa presentaci\u00f3n de la ficha t\u00e9cnica e inserto guarda\ninformaci\u00f3n de seguridad y eficacia, y deben estar\nbasados en la ficha t\u00e9cnica e inserto de una Agencia\nReguladora de un Pa\u00eds de Alta Vigilancia Sanitaria\n(PAVS), Agencia Europea de Medicamentos (EMA) u\nOrganizaci\u00f3n Mundial de la Salud (OMS).\nDe no encontrarse informaci\u00f3n en estas agencias, la\nficha t\u00e9cnica e inserto puede adecuarse como m\u00ednimo\nal Formulario Nacional de Medicamentos Esenciales.<\/td>\n<\/tr>\n
La presentaci\u00f3n de la ficha t\u00e9cnica e inserto guarda\ninformaci\u00f3n de seguridad y eficacia, y deben estar\nbasados en la ficha t\u00e9cnica e inserto de una Agencia\nReguladora de un Pa\u00eds de Alta Vigilancia Sanitaria\n(PAVS), Agencia Europea de Medicamentos (EMA) u\nOrganizaci\u00f3n Mundial de la Salud (OMS).\nEn caso de no encontrarse la especialidad\nfarmac\u00e9utica en estas agencias se debe sustentar\nla seguridad y eficacia del producto a registrar con\ninformaci\u00f3n o estudios pre-cl\u00ednicos y cl\u00ednicos que\nevidencien esas caracter\u00edsticas.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n
Categoria 2<\/strong><\/td>\nE s p e c i a l i d a d e s\nfarmac\u00e9uticas cuyos\ni n g r e d i e n t e s\nfarmac\u00e9uticos activos\no asociaciones no se\nencuentran en el\nPetitorio Nacional\n\u00da n i c o d e\nM e d i c a m e n t o s\nEsenciales (PNUME)\ny que se encuentran\nregistrados en alg\u00fan\nP a \u00ed s d e A l t a\nVigilancia Sanitaria\n(PAVS).<\/td>\n<\/p>\n\n\n\n\n
Forma farmac\u00e9utica,\ncantidad del IFA y v\u00eda\nde administraci\u00f3n igual\na la registrada en un\nPAVS, EMA u OMS.<\/p>\n

\u00a0<\/td>\n<\/tr>\n

Forma farmac\u00e9utica,\ncantidad del IFA y\/o v\u00eda\nd e a dmi n i s tr a c i \u00f3 n\nd i f e r e n t e a l a\nregistrada en un PAVS.<\/p>\n

\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n

<\/p>\n\n\n\n\n\n
La informaci\u00f3n t\u00e9cnica de seguridad y eficacia estar\u00eda\ndado por la informaci\u00f3n proveniente de la ficha\nt\u00e9cnica e inserto actualizados de un PAVS, EMA u\nOMS. Informaci\u00f3n con la que se elaborar\u00eda el inserto\ny ficha t\u00e9cnica de la especialidad farmac\u00e9utica a\nregistrar.<\/td>\n<\/tr>\n
Se deber\u00e1 presentar sustento de la seguridad y\neficacia de la especialidad a registrar con informaci\u00f3n\no estudios pre-cl\u00ednicos y cl\u00ednicos que evidencien esas\ncaracter\u00edsticas.La informaci\u00f3n contenida en el inserto y ficha t\u00e9cnica\ndebe estar basada en el sustento de seguridad y\neficacia presentado.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n
Categoria 3<\/strong><\/td>\nE s p e c i a l i d a d e s\nfarmac\u00e9uticas cuyos\ni n g r e d i e n t e s\nfarmac\u00e9uticos activos\no asociaciones no se\nencuentran en las\ncategor\u00edas 1 y 2<\/td>\n\u2022 Monof\u00e1rmacos.
\n\u2022 Combinaciones en\nlas que al menos un\nIFA no se encuentre\npresente en las\ncategor\u00edas 1 o 2.
\n\u2022 Nueva entidad\nqu\u00edmica.<\/td>\n		Se requerir\u00e1 presentar el debido sustento de\nseguridad y eficacia, el cual debe basarse en\nlineamientos internacionales tales como los de la\nOMS, FDA, ICH y\/o EMA.
\nLa informaci\u00f3n contenida en el inserto y ficha t\u00e9cnica\ndebe estar basada en el sustento de seguridad y\neficacia presentado.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

(Autor\u00eda propia)<\/strong><\/p>\n

De manera general, si no se contase con una especialidad farmac\u00e9utica igual a la registrada en el\nPNUME, PAVS, EMA u OMS, el sustento de seguridad y eficacia estar\u00eda dado por bibliograf\u00eda de\nreferencia objetiva y de reconocido prestigio como el formulario de la OMS, Formulario Nacional Brit\u00e1nico\n(BNF), Martindale, UpTodate, Cochrane, PubMed entre otras; a trav\u00e9s de estudios cl\u00ednicos, estudios\npragm\u00e1ticos, revisiones sistem\u00e1ticas, estudios observacionales, estudios epidemiol\u00f3gicos,\ninvestigaciones bibliogr\u00e1ficas y estudios bibliom\u00e9tricos, seg\u00fan corresponda, del IFA en la misma forma\nfarmac\u00e9utica, concentraci\u00f3n\/dosis y v\u00eda de administraci\u00f3n a registrar.\n\nOtros de los requisitos que est\u00e1n relacionados con la seguridad y eficacia del producto a registrar son los\nEstudios de equivalencia terap\u00e9utica para demostrar la intercambiabilidad y Plan de Gesti\u00f3n de Riesgo.\nPara la presentaci\u00f3n de los estudios de equivalencia, se deben seguir las directrices descritas en el\nDecreto Supremo N\u00b0 024-2018-SA<\/b>, adem\u00e1s de considerar las listas de medicamentos a los cuales se\nles exige la presentaci\u00f3n de estos estudios, los cuales se presentan en el Anexo 1 y 2 de la RM_404-\n2021\/MINSA.<\/b> Para la elaboraci\u00f3n del Plan de gesti\u00f3n de riesgo existe la Norma T\u00e9cnica de Salud\nN\u00b0156-MINSA\/2019\/DIGEMID <\/b>y se presenta cuando la especialidad farmac\u00e9utica contiene un IFAque no\nha sido registrado previamente en el pa\u00eds.\n\nToda la informaci\u00f3n que se vaya a presentar a fin de sustentar la seguridad y eficacia, tambi\u00e9n se va a ver\nplasmada en dos documentos muy importantes, los cuales son el inserto y la ficha t\u00e9cnica, que van\ndirigidos a la poblaci\u00f3n y profesionales de salud, respectivamente. Cabe mencionar que la informaci\u00f3n\npresente en estos documentos, debe corresponderse con la informaci\u00f3n de seguridad y eficacia que se\npresenta de acuerdo a lo expresado en el cuadro anterior.\n\nPor \u00faltimo, un detalle tambi\u00e9n importante es tener presente las alertas seguridad que se emiten por la\nAutoridad Nacional de Medicamentos (DIGEMID), PAVS, EMA u OMS las que pueden exigir ciertas\ndisposiciones que se deber\u00e1n cumplir como parte de la presentaci\u00f3n de la informaci\u00f3n de seguridad y\neficacia.\n\nEn conclusi\u00f3n, es sumamente importante estar a la vanguardia de las actualizaciones que se dan en la\nnormativa peruana y en los nuevos lineamientos que continuamente se van emitiendo por los diversos\npa\u00edses de alta vigilancia y agencias sanitarias en el mundo, ya que nos permitir\u00e1n asegurar que la\nespecialidad farmac\u00e9utica que se pretende comercializar en Per\u00fa, cumpla con las exigencias m\u00ednimas\nque sustenten su seguridad y eficacia, as\u00ed como su acceso adecuado por parte de la poblaci\u00f3n.<\/p>","protected":false},"excerpt":{"rendered":"

Q.F. Ronald Erik Qui\u00f1onez Dextre Regulatory Affairs, Safety and Efficacy Analyst SCR Consulting Peru With the enactment of the Law No. 29459: \u201cLaw on Pharmaceutical Products, Medical Devices and Health Products\u201d in 2009; and subsequently with the approval of the \u201cRegulations for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health […]<\/p>\n","protected":false},"author":4,"featured_media":4669,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,87],"tags":[],"class_list":["post-4668","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-regulatory-affairs"],"yoast_head":"\nPeru DIGEMID: Safety and Efficacy Requirements for Pharmaceutical Product Registration<\/title>\n<meta name=\"description\" content=\"Learn how Peru\u2019s DIGEMID defines safety and efficacy evidence for 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