PHOTO 2019 11 25 10 09 01

Washington, DC, 7 January 2020 (PAHO)—National health authorities from pandemic influenza preparedness (PIP) target countries: Bolivia, Guyana, Honduras, Nicaragua, and Peru, in addition to Chile and El Salvador, participated at the “Implementation workshop of the WHO Guidelines on regulatory preparedness for provision of marketing authorization of human pandemic influenza vaccines in non-vaccine producing countries”. The event, hosted by the World Health Organization, the Pan American Health Organization and the country office in Peru, was held in Lima, Peru, from 25-27 November 2019.  

The WHO Guidelines provide guidance on the identification of appropriate regulatory approaches to the marketing authorization of pandemic influenza vaccines and on arrangements for lot release of these vaccines in public health emergencies.  

“The implementation of these Guidelines will enable countries to strengthen their regulatory capacities in regulating influenza products, including vaccines, antivirals and diagnostics, to accelerate national approval of these commodities in case of pandemic influenza,” said María luz Pombo, Advisor, Vaccines and Biotechnological Products at PAHO. Regulatory system strengthening is part of the pandemic influenza preparedness framework.

During the three-day meeting, local authorities and stakeholders discussed the links between national pandemic influenza preparedness plans, national influenza vaccine deployment plans, and the role of the national regulatory authority for medical products. They also explored recommended practices on reliance on the decisions and expertise of other regulatory authorities, and the WHO recommendations for composition of seasonal influenza and pandemic vaccines. 

The workshop agenda included the following topics: 

  • General considerations for regulatory preparedness for pandemic influenza vaccines
  • Country regulatory preparedness for pandemic influenza
  • Regulatory evaluation processes
  • Quality control preparedness and vaccine safety monitoring
  • Pandemic simulation: putting it all together

A two-year country roadmap for implementation of the WHO Guidelines on regulatory preparedness for provision of marketing authorization of human pandemic influenza vaccines in non-vaccine-producing countries was developed by participants and will be discussed locally for their endorsement. 

In addition, the Medicines and Health Technologies Unit at PAHO will coordinate virtual meetings to discuss resource mobilization to support regulatory system strengthening and to communicate to all stakeholders’ expectations on improving regulatory decisions under pandemic influenza and responses to other public health emergencies.

This unique opportunity of inter programmatic work included participation of national regulatory authorities (responsible for marketing authorization of medical products); national Expanded Program for Immunization (EPI) managers; coordinators of pandemic response and their counterparts for ensuring appropriate logistics and vaccination operations; as well as WHO Country Offices responsible for health systems and services, immunization and/or response to public health emergencies.

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