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COVID-19 highlights need for strengthening national regulatory authorities in Latin America and the Caribbean

PAHO report: COVID-19 highlights need for strengthening national regulatory authorities in Latin America and the Caribbean
Study draws lessons for the region from the six national regulatory authorities of reference in Argentina, Brazil, Chile, Colombia, Cuba, and Mexico.

Washington, D.C., April 26, 2021 (PAHO) The COVID-19 pandemic has demonstrated the urgent need for strengthening national regulatory authorities in Latin America and the Caribbean to ensure the safety and effectiveness of new medicines and medical products, a new report by the Pan American Health Organization (PAHO) asserts.

“During the pandemic, we have watched the rapid deployment of clinical trials, the introduction of new and repurposed treatments, and now the development and use of new vaccines, many based on innovative and groundbreaking technological platforms,” said PAHO Assistant Director Jarbas Barbosa. “Throughout these processes, the role of regulatory authorities as independent and science-based institutions has proven more critical than ever.”

The report shows that national regulatory authorities vary dramatically in their capacity to evaluate medicines and medical products. The report draws lessons for improvement from six national regulatory authorities in the region, which PAHO has designated as National Regulatory Authorities of Reference (NRAr). These authorities are ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), INVIMA (Colombia), CECMED (Cuba), and COFEPRIS (Mexico).

Key findings include:

  • Robust regulatory capacities result from expansive legal and organizational frameworks, which give NRArs technical independence and strong mandates to supervise and sanction the pharmaceutical product approvals within their jurisdictions.
  • Recent reforms in national regulatory authorities have brought important improvement in access to medicines and transparency within the authorities.
  • Financial and human resources for national regulatory authorities have remained relatively static over the last five years in Latin America while the pharmaceutical market has increased both in value, volume and medical product complexity.
  • The manufacture of increasingly complex medical products requires stronger surveillance and control. Post-marketing surveillance and pharmacovigilance is a potential weakness of systems.
  • Advances in national regulatory authorities have helped catalyze improvements in other countries and regions. The creation of the Caribbean regulatory system and the Central American joint working system reflect an improvement of regulatory capacity.

The report raises concerns about the “limited or complete lack of legal and organizational frameworks for regulatory systems in a number of countries.”  It encourages countries with less capacity to rely, whenever possible, on evaluations and approvals already completed by one or more of the NRArs.

The report also highlights emergency measures that authorities have implemented since the beginning of the COVID-19 pandemic to improve access to health technologies essential for response and mitigation. “Yet the pursuit of accelerating access, while safeguarding the safety, effectiveness and quality of the products, created tensions and pressures within national regulatory authorities,” Dr. Barbosa said.

In 2010, PAHO member countries adopted a resolution calling for strengthening regulatory systems, which was the first of its kind for the World Health Organization (WHO).  The resolution established regulatory systems as a public health priority and underscored the need to ensure that medical products comply with international standards and are affordable and accessible.

“The Region of the Americas has made great progress in strengthening national regulatory authorities over the past decade, but work must continue,” Dr. Barbosa said.  “Strengthening regulatory systems takes time and commitment, and requires national leadership for sustainability.”

LINKS 
“Regulatory System Strengthening in the Americas” (English)
“Fortalecimiento del systema regulatorio en las Américas”  (Spanish)
Virtual launch of “Regulatory System Strengthening in the Americas” (Original audio)
Virtual launch of “Regulatory System Strengthening in the Americas” (English)
Lanzamiento virtual de “Fortalecimiento del sistema regulatorio en las Américas” (Spanish)

[Original press at PAHO’s website]

 
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55th Report – WHO Expert Committee on Specifications for Pharmaceutical Preparations

The 55th WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) is now available at: https://apps.who.int/iris/bitstream/handle/10665/340323/9789240020900-eng.pdf. It will be included on the agenda and presented to the 149th session of the WHO Executive Board.

Important to mention that the chapter 9  “Regulatory guidance and model schemes”  of such document includes:

  • WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce (page 36)
  • Good reliance practices in the regulation of medical products (page 38)
  • Good regulatory practices in the regulation of medical products (page 39)
  •  Update on WHO-listed authorities (page 40)

 

 

 
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PAHO Director says COVID-19 vaccines for the Americas still recommended despite new variants

10 Feb 2021

“PAHO’s surveillance network is keeping a close watch on today’s variants of concern.”

Washington, D.C., February 10, 2021 (PAHO) Pan American Health Organization (PAHO) Director Carissa F. Etienne said the COVID-19 vaccines soon to be available from COVAX in the Americas are still recommended for the region, despite new variants of the SARS-CoV-2 virus that causes the disease.

Based on the evidence we have now on the variants of concern, we are confident that our growing portfolio of COVID-19 vaccines remains useful and will guide us through the end of this pandemic.”

PAHO Director Carissa F. Etienne

For more information go to https://www.paho.org/en/news/10-2-2021-paho-director-says-covid-19-vaccines-americas-still-recommended-despite-new-variants

 
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Webinar: Technical and regulatory aspects of prolonged use, reuse and reprocessing of respirators in periods of shortage

In 2 July 2020, the Pan American Health Organization (PAHO) organized a webinar on technical and regulatory aspects of prolonged use, reuse and reprocessing of respirators in periods of shortage.

Such webinar aimed to present issues related to the extended use, reuse, and reprocessing of N95 and equivalent respirators by health services during shortages of this personal protective equipment (PPE), to health facility managers, health authorities, and others involved in decision-making on the use and prioritization of PPE.

This session was based on a PAHO document that presents considerations for the prolonged use, reuse, and reprocessing of N95 respirators and equivalents by health services during periods of shortage of PPE. This document summarizes the available evidence on existing reprocessing methods for N95 respirators and equivalents. The recommendations are preliminary and are subject to review as new evidence becomes available. This document is available at https://www.paho.org/en/file/66805/download?token=DAkp6drm.

The webinar is available in English at the Campus Virtual for Public Health:  https://www.campusvirtualsp.org/en/webinar/technical-and-regulatory-aspects-prolonged-use-reuse-and-reprocessing-respirators-periods