The Pan American Health Organization invites you to celebrate Universal Health Day 2019, with the theme “Universal health: everyone, everywhere” – Compact on Primary Health Care for Universal Health 2030.
The PAHO Director, Carissa F. Etienne, and representatives from the academic field, NGOs, and U.S. authorities will participate of the event. Speakers will talk about achievements and new challenges to achieve Universal Health by 2030, with reference to the Compact 30.30.30: Primary Health Care for Universal Health.

When: Thursday, 12 December 2019
Time: 10 AM (EDT)
How: www.vimeo.com/pahotv

The International Pharmaceutical Regulators provide Training Manual on the Basic of Analytical Comparability of Biosimilar Monoclonal Antibodies (English, Spanish, Russian) at http://www.iprp.global/page/biosimilar-activities

WHO Expert Committee on Biological Standardization (ECBS) have been posted main outcomes of the meeting held from 21 to 25 October 2019 on the biologicals website at the url as follows: https://www.who.int/biologicals/WHO_ECBS/en/

Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines; and Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) – Amendments (2019) to Annex 3 of WHO TRS No. 993

Please note that, as stated in the document, they are now subject to WHO editorial review and there will be further editorial changes but without affecting the technical contents.  The final version will be published in the WHO Technical Report Series (TRS) in 2020.

The FDA and the European Medicines Agency (EMA) are publishing the discussion and main conclusions from a workshop held on November 26, 2018, at the EMA headquarters in London, supporting quality development for the FDA’s Breakthrough Therapy Designation and EMA’s Priority Medicines (PRIME) programs for patients with unmet medical needs. The workshop between regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of robust quality data packages, to enable timely access to medicines for patients while keeping in mind the importance of drug safety and quality and maintaining current standards of approval.

For more information go to https://www.fda.gov/news-events/fda-brief/fda-brief-fda-european-medicines-agency-collaborate-drug-quality-and-manufacturing-data-improve 

Belmopan. July 16, 2019.  As part of its ongoing initiatives to provide quality healthcare medications, the Ministry of Health sent five different generic medications to the Caribbean Regional Public Health Agency’s (CARPHA) Drug Testing Laboratory, which is CARICOM’s regional reference laboratory for testing. The medications range from antibiotics to antidiabetic drugs that were sampled from the public sector.

All five medications have passed the quality tests performed as per international standards. This means that these generic medications are of confirmed quality.

The medications tested were:

The medications were selected based on a risk-based approach strategy which includes medications from the larger population and public health program. The Ministry remains committed in the continuous monitoring of pharmaceuticals and hereby seeks ongoing public engagement in reporting any suspicious medication to the Drug Inspectorate Unit at 828-4467 or via the drugalert@health.gov.bz email.

Ends

For more information, contact:

Mrs. Danini Marin

Director – Drug Inspectorate Unit, Ministry of Health

828-4466

WHO published a Concept Note entitled “A FRAMEWORK FOR EVALUATING AND PUBLICLY DESIGNATING REGULATORY AUTHORITIES AS WHO-LISTED AUTHORITIES”, which will be posted on the WHO Medicines website under Current Projects for public revision and comments  (https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_808_WHO_listed_authorities.pdf?ua=1).

This Concept Note presents a proposed definition for WHO-Listed Authorities (WLAs); procedures for designating a WLA; and the process for finalizing the definition and the procedures for putting the framework into place.

Given the wide interest in and implications associated with the definition and framework, WHO will adopt a multi-prong consultation process as outlined in this Concept Note.  Further details will be announced in due course.

All comments received by 17 July 2019 will be considered in the preparation of a draft policy and draft operational guidance documents. Please send any comments you may have to nra_admin@who.int , with a copy to Ms Claire Vogel (vogelc@who.int).

March 19, 2019
Our file number: 19-101967-390

Under the Regulatory Review of Drugs and Devices initiative, Health Canada is increasing the efficiency of the regulatory system and supporting timely access to therapeutic products. As part of this initiative, Health Canada is pleased to announce the launch of the e-Learning tool, Understanding How Medical Devices are Regulated in Canada – Premarket Regulation.

This web-based tool, designed as an interactive learning platform, offers an overview of Health Canada’s premarket regulatory requirements for medical devices. It also provides targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

The tool serves as a valuable, comprehensive, and organized source of premarket regulatory information for various medical device stakeholder groups, including manufacturers, importers, distributors, consultants, healthcare groups, and academia. By providing e-Learning content to  manufacturers and other relevant stakeholders, it is expected that the completeness and quality of Medical Device Licence applications will improve, thereby resulting in more positive, and more timely, regulatory decisions.

Health Canada encourages and invites stakeholders to utilize and benefit from this new educational tool.

Questions or concerns regarding this notice or the e-Learning tool should be directed to the Medical Devices Bureau at hc.mdb.enquiries-enquetes.bmm.sc@canada.ca.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-e-learning.html

We would like to share with you the invitation received in its original language (Spanish) to participate in the Health Technology Assessment Network of the Americas (Red de Evaluación de Tecnologías en Salud de las Américas – RedETSA) webinar program on 29 March, 11am (EST) where Alfredo Palacios, Instituto de Efectividad Clínica y Sanitaria (IECS) will discuss the “Web model of budget impact analysis”.

The link that will be used to access this Webinar is available as follows: https://goo.gl/Rxrxki

Alerta Farmacéutica 2/19 – Retiro del Mercado

Clonixinato de Lisina Solución Inyectable 100mg/2 mL. (analgésico, antiinflamatorio no esteroidal (Aines)

Serie 75MH1541 – 75ML2081.

Fecha de vencimiento: 08/2021 – 11/2021

Fabricante: Laboratorio Sanderson S.A/Chile

Descripción del defecto: Presencia de partículas, cuyo origen se encuentra en estudio.

más informaciones por el enlace http://www.ispch.cl/sites/default/files/comunicado/2019/02/19-02-2019%20-%20Presencia%20de%20partículas%20clonixinato%20de%20lisina…..pdf

They set up an analysis to discuss Mexico’s participation in the Revolving and Strategic Funds of PAHO / WHO.

As an active member of the PAHO / WHO Pan-American and World Health Organizations, Mexico seeks the direct purchase of certain vaccines and medicines through Revolving and Strategic Funds from these international organizations, from which it would obtain benefits with respect to the prices offered.

For more information go to https://www.gob.mx/cofepris/articulos/mexico-avanza-en-compra-consolidada-de-vacunas-y-medicamentos-186105?idiom=es