Murilo Freitas – Page 31

Agemed prioriza la importación de medicamentos oncológicos para pacientes con cáncer

Murilo Freitas - 12:01, 26 de March de 2018923

La Paz – Lunes 26 de Marzo de 2018 | Unidad de Comunicación

El trámite para la importación de medicamentos oncológicos dura 10 días, en el caso de ser refrigerados concluye en 24 horas, informó la directora General Ejecutiva de la Agencia Estatal de Medicamentos y Tecnologías en Salud, María Carrasco.

“Este trámite debe concluir en el lapso de 10 días, a diferencia de otros productos farmacéuticos que por norma duran 30 días”, explicó la autoridad.

De acuerdo con la Ley del Medicamento N. 1737, aprobada en 1996, todos los productos deben cumplir requisitos como el registro sanitario vigente, importación, autorizaciones para despacho aduanero, entre otros.

En Bolivia, los fármacos para tratar el cáncer figuran en el Listado Nacional de Medicamentos Esenciales (Liname), por tanto en la gestión 2017 la Agemed amplió de 38 a 54 los tipos de productos importados.

“Si el medicamento viene refrigerado, ese despacho aduanero se aprueba en 24 horas, normalmente este trámite se extiende por cinco días, pero nosotros buscamos facilitar su acceso a la población”, remarcó.

Denuncias

Actualmente, la dirección de la Agemed no recibió denuncias por desabastecimiento de medicamentos oncológicos en el país.

“Existen 24 empresas habilitadas para la importación de estos fármacos y hasta el momento ninguno manifestó problemas o demoras en sus trámites”, dijo Carrasco.

En ese marco, pidió a los pacientes, establecimientos de salud e instituciones denunciar ante los Servicios Departamentales de Salud (Sedes) y a la propia Agemed alguna carencia o desabastecimiento de estos fármacos, para proceder con la investigación correspondiente.
NES/

Fuente: https://www.minsalud.gob.bo/3175-agemed-prioriza-la-importacion-de-medicamentos-oncologicos-para-pacientes-con-cancer

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Webinar: regulation of advanced therapy products [in Portuguese]

Murilo Freitas - 16:41, 20 de March de 2018840

[Original text in Portuguese]

Online event will introduce the regulatory concepts for advanced therapy products and Anvisa’s perspectives to the topic.

By: Ascom / Anvisa

Posted: 03/16/2018 11:39

Last Modified: 03/19/2018 08:50

Anvisa will hold a webinar on advanced therapy products next week. These therapies involve products of cellular therapies, technology that use human cells, among others. The event will take place on March 22, at 3:00 p.m.

During the webinar, the Blood, Tissues, Cells and Organs Department will give a presentation on the topic and answer participants’ questions about the regulation of the sector.

The webinar is an online webcast conference where participants can interact through a messaging service, such as a chat, and send questions to the technical panel. The talk transmitted is stored on the Agency’s website and can be accessed at other times for the correction of doubts.

How to participate

To participate, just access the link below on March 22 at 15h.

Link to access event: Regulation of Advanced Therapy Products

The webinar is an initiative of Anvisa’s Knowledge Management area and aims to strengthen the Agency’s active transparency initiatives, bringing updated knowledge to the external public.

Want to know Anvisa news first hand? Follow us on Twitter @anvisa_oficial and Facebook @AnvisaOficial

Source: http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4170985

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Belize – Unauthorized and suspected falsified Dayamineral ® Syrup 240ml bottle

Murilo Freitas - 11:36, 15 de March de 2018914

13th March 2018

Drug Alert No. 1/2018

Dayamineral ® 240ml Syrup

The Ministry of Health would like to inform the public on unauthorized and suspected falsified Dayamineral ® Syrup 240ml bottle that has been found to be circulating the market and has been confiscated. Investigations conducted by the Ministry are indicative that this Dayamineral Syrup found has not been granted entry into the country by the Ministry of Health and the quality may be compromised.

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For more information go to http://health.gov.bz/www/attachments/article/978/Alert%20No1-2018.pdf

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Directora de la OPS presenta en Brasil panorama de la medicina tradicional en las Américas

Murilo Freitas - 10:19, 14 de March de 20181,211

Río de Janeiro, Brasil, 12 de marzo de 2018 (OPS/OMS)– La directora de la Organización Panamericana de la Salud (OPS), Carissa F. Etienne, presentó un panorama sobre la medicina tradicional en la región de las Américas, durante la apertura del 1º Congreso Internacional de Prácticas Integrativas y Salud Pública, que se desarrolla hasta el jueves en Río de Janeiro.

“Acelerar los esfuerzos de los países para lograr la salud universal en 2030 – como se comprometió el mundo en la nueva Agenda de Desarrollo Sostenible – requiere escuchar las voces de las personas, prestar atención a las múltiples formas de entender el mundo en que vivimos, las múltiples culturas y tradiciones, incluida su medicina tradicional”, afirmó Etienne.

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For more information go to http://www.paho.org/hq/index.php?option=com_content&view=article&id=14186%3Adirectora-de-la-ops-presenta-en-brasil-panorama-de-la-medicina-tradicional-en-las-americas&catid=1443%3Aweb-bulletins&Itemid=135&lang=en

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INVIMA: VITACEREBRINA FRANCESA ES UN PRODUCTO FRAUDULENTO

Murilo Freitas - 12:50, 13 de March de 20181,600

Un total de seis alertas sanitarias ha emitido el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) en el último año sobre el producto Vitacerebrina Francesa, el cual no tiene registro sanitario, por lo cual su comercialización en Colombia es ilegal y se considera fraudulento.

Al desconocerse su composición, este producto puede contener sustancias que afectan la salud e incluso comprometan la vida de quienes lo consumen, por lo cual se ha recomendado a las personas no consumirlo y denunciar los lugares donde es comercializado.

Este producto también se vende bajo varios nombres similares como: Mega Vitacerebrina o Mega Max Vitacerebrina Francesa y usan registros sanitarios falsos para engañar a las personas y hacerles creer que son productos legales. Algunos ejemplos de registros falsos: RSAD12L01632, RSAD15I25638, RSAE 12I11504.

Estos productos son promocionados como alimentos con propiedades medicinales que prometen mejorar el coeficiente intelectual, dar vitalidad, energía y curar enfermedades del hígado, riñones, corazón y hasta el cáncer de mama, según lo publicitan en sus empaques.

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Más informaciones por el enlace: https://www.invima.gov.co/%C2%A1ojo%C2%A1,-vitacerebrina-francesa-es-un-producto-fraudulento.html

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Gender equality must be at the core of ‘Health for All’

Murilo Freitas - 13:38, 8 de March de 20183,057

International Women’s Day Statement by WHO Director-General Dr Tedros Adhanom Ghebreyesus

7 March 2018 – On this International Women’s Day, we imagine a world where every woman and girl has access to quality and affordable health care, a world in which women and girls can freely exercise their sexual and reproductive health rights, and one where all women and girls are treated and respected as equals.

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WHO PUBLIC CONSULTATION: CALL FOR COMMENTS ON GUIDELINES FOR THE SAFE PRODUCTION AND QUALITY CONTROL OF POLIOMYELITIS VACCINE

Murilo Freitas - 14:14, 7 de March de 20181,500

The WHO Regulatory Standards for Vaccines and Biologicals unit opened a public consultation for regulators, manufacturers and other experts. The following document has been posted on the WHO biologicals web site http://www.who.int/biologicals/en/ for public comments:

Guidelines for the safe production and quality control of poliomyelitis vaccine

http://www.who.int/biologicals/WHO_Safe_production_of_Polio_1st_PC_6_March_2018.pdf?ua=1

Comment Form http://www.who.int/entity/biologicals/Comment_Form_POLIO_6_March_2018.doc?ua=1

DEADLINE for submission of comments: 04 April 2018

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Anvisa: Lots of the Sutent® cancer drug were counterfeit

Murilo Freitas - 13:16, 6 de March de 20181,146

By: Ascom / Anvisa
Posted: 03/03/2018 10:30
Last Modified: 03/03/2018 10:44

Pfizer Lab has identified 11 counterfeit lots that have not left its factory. Cancer drug is used in hospitals.

In a resolution published on Monday (5/3) in the Federal Official Gazette (DOU), Anvisa banned 11 falsified batches of the cancer drug Sutent® in the package with 28 50 mg capsules. Batches 746EE, 747EE, 748EE, 190EE, 045AA, 191EE, 189EE, 985EE, 986EE, 987EE and 749EE are falsified.

For more information go to: http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4131460

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REGULATORY AUTHORITIES OF THE PACIFIC ALLIANCE SIGN AGREEMENT TO IMPROVE THE REGISTRATION OF MEDICINES

Murilo Freitas - 19:21, 1 de March de 20181,122

• Colombia, Chile and Mexico advance on issues of pharmaceutical cooperation and reduce the gap in bioequivalence
• Within the framework of the meeting held in Medellin, Colombia, the regulatory authorities created a permanent technical team to consolidate harmonization and regulatory convergence
• Regional integration in regulatory matters responds to presidential mandates, has a long-term scope and clear benefits for the health of the population

In the framework of the meeting of the Inter-institutional Cooperation Agreement between Regulatory Authorities of the Pacific Alliance, which took place on March 1 and 2 in Medellín, Colombia, the authorities of Colombia, Chile and Mexico signed a commitment on Friday that will speed up the registration of medicines in the Region.

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For more information go to https://www.invima.gov.co/autoridades-sanitarias-de-la-alianza-del-pac%C3%ADfico-firman-compromiso-para-agilizar-el-registro-de-medicamentos.html

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Canada: Revised versions of drug good manufacturing practices (GMP) documents are available

Murilo Freitas - 18:38, 1 de March de 20183,526

On February 28, 2018, the Health Products Compliance Directorate posted four drug good manufacturing practices (GMP) documents to the Health Canada website. These documents are:

GUI-0001, GUI-0023, and GUI-0031 are revised versions of currently posted documents and GUI-0119 is a new document to replace the sterile products section of GUI-0001. These documents, except for GUI-0023, have an implementation date of October 1, 2018.

GUI-0023 will be implemented effective immediately as it will help you better understand how Health Canada currently assigns the risk rating to GMP inspection findings and the compliance rating for a GMP inspection. There are important changes in this guide as it relates to lower risk products and activities.

These documents have been updated to:

address emerging issues such as increased reliance on foreign fabricators, packagers/labellers, and testers, and emerging trends such as data integrity,
incoporate additional sample observations,
help the medical gas industry comply with regulations,
help industry comply with the regulations as they relate to sterile drugs, and
be reformatted using plain language principles in accordance with new Canada.ca requirements, soon to be in effect.

Health Canada will host a series of webinars to review the revised guidance documents, highlight key changes and to answer any related questions. You can expect to receive invitations in the near future to attend webinars scheduled for:

Thursday, March 29, 2018 on Good manufacturing practices for medical gases (GUI-0031), and
May/June 2018 on the other three guidance documents (GUI-0001, GUI-0023, and GUI-0119).

Source: Health Product Inspection and Licensing Division