**notícia em inglês**

A public consultation on the following documents is now open:

Based on WHO consultations with regulators, manufacturers and other experts the following documents were prepared and have been posted on the WHO biologicals web site http://www.who.int/biologicals/en/ for public comments:

DEADLINE for submission of comments: 12 FEBRUARY 2018

1. WHO biosafety risk assessment and guidelines for the production and quality control of novel human influenza candidate vaccine viruses and pandemic vaccines:  http://www.who.int/biologicals/vaccines/INFLUENZA_BIOSAFETY_GL_draft_1_1st_PC_22_Nov_2017_TZ.pdf?ua=1

2. Recommendations to assure the quality, safety and efficacy of recombinant hepatitis E vaccines http://www.who.int/biologicals/vaccines/HEP_E_VACCINES_Recommendations_draft_1_public_consultation.pdf?ua=1

DEADLINE for submission of comments: 23 FEBRUARY 2018

1.  WHO Questions and Answers: Similar Biotherapeutic Products : http://www.who.int/biologicals/QA_for_SBPs_HK_12_Dec_2017_(2).pdf?ua=1

All comments received by the published deadlines (shown above) will be considered in the preparation of documents that will be further discussed in 2018.

[Texto original em espanhol]

Desde el lunes 4 y hasta el jueves 7 de diciembre, en el marco de un proyecto de cooperación institucional con el ISP, técnicos chilenos trabajaron en conjunto con funcionarios de la DNVS en el fortalecimiento institucional, dando varias presentaciones, consejo profesional e intercambio de experiencias relevantes con el equipo institucional y también reuniones en el Gabinete del Ministro de Salud y en la Organización Panamericana de la Salud.

Estas actividades conjuntas se encuentran en el marco del Plan de Desarrollo Institucional (PDI) de la DNVS y tuvo el objetivo de asesorar en las siguientes áreas: a) Sistema regulador, b) Registro, Licenciamiento de Productores, c) Inspecciones, d) Laboratorio Oficial de Medicamentos, y e) Liberación de lotes de vacunas.

Fuente:

https://www.mspbs.gov.py/dnvs/13848/expertos-del-instituto-de-salud-publica-de-chile-hacen-visita-de-cooperacion-tecnica-en-la-dnvs.html

Health sector stakeholders were, this morning, briefed on the importance of having safe and quality pharmaceutical drugs on the local market.

The workshop was held at Duke Lodge and sought to utilise the professional standards of the Caribbean Regulatory System to strengthen the function and regulatory capacity in Guyana.

Government Analyst Food and Drug Department (GA-FDD) Director Marlan Cole noted that even though Guyana has stringent measures in procuring drugs, the government recognises the challenges it faces in the registration of quality pharmaceutical drugs, locally.

According to the Food and Drug Director, it is critical to ensure that “those who are responsible for procurement, those who are responsible for drugs at the Georgetown Public Hospital were invited to ensure that they are sensitised as it relates to the requirements, the support, the functions and capacity of the CRS.”

For more information go to http://gina.gov.gy/guyana-to-adopt-crs-measures-for-procurement-of-pharmaceuticals/  

The Caribbean Regulatory System (CRS) 

The draft document of ‘WHO Questions and Answers: Similar Biotherapeutic Products’ is available at WHO biological website (http://www.who.int/biologicals/en/). WHO is requesting a feedback from a broad audience of regulators, manufacturers, and other experts. The document is going to be exposed to the public by 23 Feb 2018.

You could download the document directly by clicking on the following link:

http://www.who.int/biologicals/QA_for_SBPs_HK_12_Dec_2017_(2).pdf?ua=1.

In order to provide your comments, please use the template, http://www.who.int/entity/biologicals/WHO_QA_Comment_Form_WHO_QA_30_Nov_2017.doc?ua=1.

If you prefer, you could also use the draft document and comment form attached in this email.

In case that you need any other information, please contact Dr HyeNa KANG (Scientist, Technologies Standards and Norms (Team),Essential Medicines and Health Products (Department), WHO) by kangh@who.int.

La Red de Puntos Focales de Farmacovigilancia de las Américas tiene el gusto de invitarlo al último webinario del 2017:

Aspectos prácticos en la evaluación de estudios posautorización

Jueves 14 de diciembre de 2017, 10:30 a.m. de Washington DC, Estados Unidos

Los estudios posautorización de tipo observacional tienen como propósito completar la información disponible a partir de los Ensayos Clínicos que han servido para la autorización del medicamento.  En ocasiones este tipo de estudios se solicitan al Titular de la Autorización de Comercialización del medicamento por la Autoridad Reguladora como parte de los planes Gestión de Riesgos para resolver aspectos relativos a la seguridad o a la utilización del medicamento durante el periodo de comercialización. En ocasiones, su realización es una condición necesaria impuesta por la Autoridad Reguladora como condición para la autorización del medicamento. En otras circunstancias su realización tiene lugar por iniciativa propia del TAC.  Por todo lo anterior, existen una serie de aspectos prácticos, regulatorios, metodológicos y éticos que se deben tener en cuenta en la evaluación de los protocolos de estudios posautorización de tipo observacional.

Diego Macías Saint-Gerons es licenciado en farmacia por la Universidad de Salamanca, Máster Universitario en Métodos Cuantitativos de Investigación en Epidemiología por la Universidad Autónoma de Madrid y Doctor en Ciencias de la Salud por la Universidad Complutense de Madrid. Es autor de numerosos artículos científicos sobre la utilización de medicamentos y sus efectos. Ha trabajado en la Universidad de Valladolid, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), y como experto de la Agencia Europea de Medicamentos (EMA). Actualmente trabaja como consultor internacional (IPC) en la unidad de Medicamentos y Tecnologías de la OPS/OMS.

El acceso se proporcionará a través de:  https://paho.webex.com/paho/onstage/g.php?MTID=e3ac95f382605a7dcb95e3714c8fa92b3

Adicionalmente se podrá acceder por teléfono a través de la línea en Estados Unidos:  +1-415-655-0002 marcando el código de acceso 311 969 482

Esperamos contar con su participación.

[Texto original em inglês]

On Tuesday, December 5^th, the Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) recommended its 15th medicine for marketing authorization/import permit in the CARICOM block of countries. The product, Efavirenz, Emtricitabine, and Tenofovir (600/200/300mg), is listed on the WHO Essential Medicine List and is a first line treatment according to WHO HIV treatment guidelines. The initiative is intended to strengthen regulation in these small states, which are primarily comprised of the English speaking Caribbean, plus the French and Dutch speaking Haiti and Suriname, respectively. In addition to the focus on marketing authorization, the CRS also helps countries monitor medicines in the market by setting up a regional reporting system. To date, it has received over 70 reports, including for substandard and falsified medicines. For more information on the CARPHA/CRS please visit the website at: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS

A Assembléia do ICH anunciou a aceitação de Invima como o novo observador do ICH em uma comunicação oficial.

O Conselho Internacional para a Harmonização dos Requisitos Técnicos para Produtos Farmacêuticos (ICH) é uma iniciativa com 25 anos de existência, única em reunir as autoridades reguladoras e a indústria farmacêutica para trabalhar na convergência regulatória e nos processos de desenvolvimento e desenvolvimento de guias internacionais de referência sobre os aspectos científicos e técnicos do registro de medicamentos.

Maiores informações disponíveis pelo link https://www.invima.gov.co/images/pdf/informate/Ingreso-Invima-observador-ICH-FINAL.pdf 

[Texto original em inglês]

The World Health Organization posted on WHO biological website (http://www.who.int/biologicals/en/) the first round public related to Recommendations to assure the quality, safety and efficacy of hepatitis E vaccines. The new recommendations are available at http://www.who.int/biologicals/vaccines/HEP_E_VACCINES_Recommendations_draft_1_public_consultation.pdf?ua=1.

A comment form on hepatitis E vaccines is downloadable from the website next to the document until 12 February 2018.

The current draft recommendations was prepared based on the discussion and consensus reached by the experts from regulators, industry and academia, in the working group meeting in May 2017 and subsequent review and comments of a initial draft by the working group participants over past months.

WHO are seeking for your critical review and comments/suggestions on this document for further development and improvement. Please would you send your comments or comments from your colleagues who are involved in regulation or responsible for manufacturing and quality control of hepatitis E vaccines by using the “comment form” on the web by 12 February 2018 to leid@who.int . Your comments will be reviewed by an informal consultation and incorporated into next version of the Recommendations as appropriate. Finally the Recommendations will be submitted to ECBS for review and adoption in its meeting in October 2018.

Source: Dianliang LEI PhD, Scientist Technologies, Standards and Norms, Essential Medicines and Health Products, World Health Organization. Email: leid@who.int

Melhor monitoramento de segurança para pacientes em toda a Europa

A Agência Europeia de Medicamentos (EMA) lançou hoje uma nova e melhorada versão do EudraVigilance, o sistema de informação europeu de suspeitas de reações adversas a medicamentos que são autorizados ou estão sendo estudados em ensaios clínicos na Área Econômica Européia (EEA). O novo sistema torna mais fácil para os titulares de autorizações de marketing e patrocinadores de ensaios clínicos reportar suspeitas de reações adversas e permite uma melhor análise dessas informações em benefício da segurança dos pacientes na Europa.

Para mais informações disponíveis em EudraVigilance