{"id":5078,"date":"2023-11-07T19:50:26","date_gmt":"2023-11-08T00:50:26","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=5078"},"modified":"2026-01-27T13:01:53","modified_gmt":"2026-01-27T18:01:53","slug":"stability-studies-bolivia-agemed-guideline","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/stability-studies-bolivia-agemed-guideline\/","title":{"rendered":"Enfoque regulatorio para los estudios de estabilidad de medicamentos en Bolivia"},"content":{"rendered":"<p><b><i><strong><em>Q.F. Mary Carmen Chuquimia Socpaza<\/em><\/strong><br \/>\n<\/i><\/b><b><i><strong><em>Quality Specialist &amp; Regulatory Affairs Coordinator<\/em><\/strong><br \/>\n<\/i><\/b><b><i>SCR Consultores Bolivia<\/i><\/b><\/p>\n<p>La seguridad y la eficacia de los medicamentos dependen no solo de sus propiedades intr\u00ednsecas, sino tambi\u00e9n de su estabilidad durante el proceso de fabricaci\u00f3n. Partiendo de esta premisa, los fabricantes y la Autoridad Reguladora de Medicamentos de Bolivia deben colaborar para garantizar que todos los medicamentos comercializados en el pa\u00eds cuenten con estudios de estabilidad que permitan determinar su vida \u00fatil.<\/p>\n<p>La estabilidad de los medicamentos depende de factores ambientales, como la temperatura, la humedad y la luz, as\u00ed como de factores relacionados con el producto, entre los que destacan las propiedades fisicoqu\u00edmicas del principio activo y los excipientes, la forma farmac\u00e9utica y su composici\u00f3n, los procesos de fabricaci\u00f3n y la naturaleza y propiedades del envase utilizado.<\/p>\n<p>The Medicines Regulatory Authority (\u201cAgencia Estatal de Medicamentos y Tecnolog\u00edas en Salud &#8211; AGEMED\u201d) through the Guideline for Stability Studies of Medicines under Administrative Resolution No. 866 of October 15, 2020, indicates that it is the responsibility of the manufacturer, as part of the development of a medicine, to design and conduct adequate stability studies to gather reliable information, and to demonstrate how its quality varies over time, and under the influence of the storage conditions to which it is subjected. This information will allow proposing the period of validity during which it can be used with absolute safety.<\/p>\n<p>Asimismo, el fabricante es responsable de que los medicamentos mantengan su calidad durante su permanencia en el mercado, siempre que sean distribuidos, manipulados, almacenados o dispensados \u200b\u200bpor terceros en territorio boliviano bajo las condiciones requeridas en el empaque y almacenamiento declarados. Para tales efectos, los fabricantes de medicamentos pueden tomar como referencia la Gu\u00eda para Estudios de Estabilidad de Medicamentos mencionada anteriormente.<\/p>\n<p>La Autoridad Reguladora de Medicamentos solicita al fabricante datos sobre la estabilidad del medicamento que justifiquen el periodo de validez solicitado para el registro o la renovaci\u00f3n del registro del producto farmac\u00e9utico. Esta informaci\u00f3n se evaluar\u00e1 en funci\u00f3n de la experiencia y la evidencia cient\u00edfica actual, lo que permitir\u00e1 aprobar dicho periodo de validez.<\/p>\n<p>Los estudios de estabilidad forman parte de los requisitos reglamentarios establecidos por la normativa boliviana para el proceso de registro sanitario de nuevos productos farmac\u00e9uticos terminados (PFT) y de aquellos ya comercializados en el territorio nacional boliviano, cuyo desarrollo debe realizarse en condiciones ambientales a una temperatura de 30\u00baC \u00b1 2\u00baC y una humedad relativa del 75% HR \u00b1 5%, que corresponden a las condiciones ambientales de la zona clim\u00e1tica IVb, establecida por la Organizaci\u00f3n Mundial de la Salud-OMS, para Bolivia; estas condiciones est\u00e1n excluidas seg\u00fan las directrices para el desarrollo de estudios de estabilidad de productos biol\u00f3gicos y biotecnol\u00f3gicos.<\/p>\n<p>Seg\u00fan el Manual para el Registro Sanitario de Medicamentos, aprobado por la Resoluci\u00f3n Ministerial N\u00b0 0909 del 7 de diciembre de 2005, para cumplir con este requisito, se deben adjuntar estudios de estabilidad de al menos 2 lotes, y los protocolos correspondientes solo se aceptar\u00e1n en el caso de productos nacionales.<\/p>\n<p>Asimismo, los estudios de estabilidad de los productos terminados pueden presentarse en tablas resumen, indicando los par\u00e1metros evaluados y especificando el producto, el embalaje, la temperatura y las condiciones de humedad.<\/p>\n<p>\u00danicamente para productos de nuevo registro y tras su evaluaci\u00f3n, la Autoridad Reguladora de Medicamentos podr\u00e1 aceptar estudios de estabilidad acelerados, otorgando una vida \u00fatil m\u00e1xima de 24 meses; para los productos correspondientes al proceso de reinscripci\u00f3n, es obligatorio presentar los estudios de estabilidad en las condiciones ambientales de la zona clim\u00e1tica IVb.<\/p>\n<p>Asimismo, tras la evaluaci\u00f3n, la Autoridad podr\u00e1 aceptar la presentaci\u00f3n de Estudios de Estabilidad en las condiciones ambientales correspondientes a la zona clim\u00e1tica IVa.<\/p>\n<p><span style=\"font-weight: 400;\">Por lo mencionado anteriormente, cabe destacar que, en t\u00e9rminos de regulaci\u00f3n, los estudios de estabilidad en Bolivia no se consideran un requisito cr\u00edtico, a diferencia de lo que ocurre en pa\u00edses con alta vigilancia sanitaria, que se rigen por las normas ICH y cuentan con directrices espec\u00edficas para dichos estudios, o como ya lo establecen las normativas en algunos pa\u00edses latinoamericanos, donde los estudios de estabilidad son un requisito obligatorio que permite, entre otros, obtener el registro sanitario. En Bolivia, bastar\u00e1 con mencionar, seg\u00fan la normativa del pa\u00eds, que los estudios de estabilidad se realizan bajo las condiciones ambientales de la zona clim\u00e1tica IVb, establecidas por la Organizaci\u00f3n Mundial de la Salud (OMS).<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist &amp; Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of medicines are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Medicines Regulatory Authority must work together to ensure that all [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":5086,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,82,87],"tags":[],"class_list":["post-5078","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-pharmaceutical-products","category-regulatory-affairs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Stability Studies in Bolivia: AGEMED Requirements<\/title>\n<meta name=\"description\" content=\"Learn Bolivia\u2019s stability study requirements for medicines: AGEMED guidelines, climate zone IVb conditions, batch expectations and dossier considerations for registration and re-registration.\" \/>\n<meta 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