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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 20181,595

• 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 20184,208

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
 

 
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Articulo científico: La ética de los diseños y métodos alternativos de ensayos clínicos. Una reflexión sobre el Foro Global de Bioética en Investigación del 2017

Murilo Freitas - 16:32, 28 de February de 20181,104
La reunión anual del Foro Global de Bioética en Investigación (GFBR, por sus siglas en inglés) se llevó a cabo en Bangkok, Tailandia, el 28 y 29 de noviembre 2017 y trató sobre la ética de los diseños y métodos alternativos de ensayos clínicos en países de bajos y medianos ingresos. En esta reunión se discutieron otras formas de generar evidencias tales como los ensayos aleatorizados por conglomerado (cluster randomized trials), que consisten en la asignación al azar de grupos en lugar de individuos independientes a una intervención, aquellos en los cuales una intervención se agrega a los conglomerados de manera escalonada (stepped wedge); los ensayos con plataformas adaptativas (adaptative platforms), que permiten modificaciones al ensayo o procedimientos estadísticos del ensayo después de su inicio, sin menoscabar su validez e integridad; y los modelos con infecciones controladas en seres humanos (controlled human infection models o CHIM)…
 
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Falsificación en Nicaragua del producto Rocephin® (Ceftriaxona) 1000 mg, polvo para solución I.V

Murilo Freitas - 11:16, 28 de February de 20181,080

Información disponible en los siguientes sitios:

  1. Cuba: CECMED – COMUNICACIÓN DE RIESGO No. 01/2018.

El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), Autoridad Reguladora Nacional de la República de Cuba, informa sobre la falsificación confirmada de Rocephin® (Ceftriaxona) 1000 mg, polvo para solución i.v en Nicaragua.

Fuente: http://www.cecmed.cu/sites/default/files/adjuntos/vigilancia/comuc_riesgo/comunicacion_de_riesgo_01-2018._ceftriaxona_0.pdf

2. Ecuador: Arcsa alerta sobre lote falsificado de medicamento ROCEPHIN 1g INYECTABLE.La

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa) da a conocer a la población ecuatoriana la alerta expuesta por la PAHO/WHO-OPS/OMS, sobre el comunicado realizado por la empresa Roche por falsificación del medicamento Rocephin® 1g (ceftriaxone), polvo para solución inyectable lote L.525.

Fuente: http://www.controlsanitario.gob.ec/arcsa-alerta-sobre-lote-falsificado-de-medicamento-rocephin-1g-inyectable/

 
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Ecuador: Arcsa alerta sobre lote del producto CHAMPÚ COSVAL SALUD Y BELLEZA

Murilo Freitas - 19:39, 27 de February de 20182,000
La Agencia Nacional de Regulación Control y Vigilancia Sanitaria (Arcsa) informa a la población ecuatoriana que ha tomado conocimiento de la alerta expuesta por el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) de Colombia, sobre un lote contaminado del producto “CHAMPÚ COSVAL SALUD Y BELLEZA”.

Se trata del Lote X910915 del producto, que cuenta con Notificación Sanitaria Obligatoria colombiana No. INVIMA NSOC63380-14CO, del titular Comercio Cosval S.A.S y fabricado por Samara Cosmetics S.A.S.

Invima solicitó detener el uso del lote descrito, debido al resultado no conforme asociado con alteración de la calidad microbiológica, indicando a la comunidad en general que suspenda de inmediato su uso, debido a los riesgos que puede representar para su salud.

Ante esta información, Arcsa recomienda a la ciudadanía no comercializar, distribuir ni utilizar el producto “CHAMPÚ COSVAL SALUD Y BELLEZA”; cabe indicar que el producto no cuenta con la Notificación Sanitaria Obligatoria Ecuatoriana y por ello, al no poder garantizar su calidad, seguridad y eficacia, representa un riesgo para la salud de la población.

Arcsa invita a la ciudadanía a informar sobre la venta o distribución de productos sin Registro Sanitario y/o Notificación Sanitaria, o de dudosa procedencia, así como cualquier reacción adversa relacionada con algún producto de uso y consumo humano, a través del correo electrónico: farmaco.vigilancia@controlsanitario.gob.ec o mediante la aplicación “Arcsa Móvil”. Sus datos personales y la información brindada serán absolutamente confidenciales.

Fuente: http://www.controlsanitario.gob.ec/arcsa-alerta-sobre-lote-del-producto-champu-cosval-salud-y-belleza/

 
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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines

Murilo Freitas - 12:54, 27 de February de 20181,411

February 26, 2018

The current influenza season has been especially difficult, causing widespread illness that has affected all fifty states and resulted in a record number of hospitalizations. While healthcare professionals continue to combat this year’s flu – which may continue to affect Americans into April – we’re already partnering with other public health agencies to conduct essential work to produce next season’s influenza vaccines.

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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm598317.htm

 
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FDA: New ICH guidance for industry for Development and Manufacture of Drug Substances Q&A

Murilo Freitas - 13:23, 23 de February de 20181,897

FDA released a guidance for industry entitled “Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers.”  This guidance is intended to provide clarification to the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance document “Q11 Development and Manufacture of Drug Substances” to improve harmonization and promote convergence for information that should be provided in marketing authorization applications and Master

Source: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM542176.pdf

 

 
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ANVISA: Workshop on Clinical Evaluation of Medical Devices registration is now open

Murilo Freitas - 12:59, 23 de February de 20181,258

[Original in Portuguese]

The event, which will deal with Clinical Assessment of Medical Devices, will take place at the Agency’s headquarters on March 27th.

On March 27, Anvisa will host the workshop on Clinical Evaluation of Medical Devices. The event, which will begin at 9:00 am in the auditorium of the Agency, counts on the partnership of the Brazilian Association of the Industry of Articles and Medical, Dental, Hospital and Laboratories (Abimo), Brazilian Association of the High Technology Product Industry for Health (Abimed) and the Brazilian Association of Importers and Distributors of Health Products (Abraidi).
The workshop aims to disseminate knowledge and improve processes and practices through the sharing of national and international experiences and the identification of difficulties and challenges related to the theme.

For more information go to http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4085408 

 
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