Regulatory Capacity Building – a key Area of Work under the PIP Framework Partnership Contribution (PC) Implementation Plan 2013-2016
The overall outcome for this Area of Work is to enable Member States with weak or no regulatory capacity to regulate influenza products, including vaccines, antivirals and diagnostics, and to accelerate national approval of these products in the event of an influenza pandemic.
Rapid production and deployment of vaccines and antiviral medicines is critical to limit the potential impact of a pandemic on populations and essential services. During the 2009 influenza pandemic, some countries, especially those in the lowest income range, experienced delayed access to vaccines or could only procure an insufficient number of doses.
Armenia and Georgia are the first Member States in the WHO European Region targeted for Regulatory Capacity Building under the PIP Partnership Contribution Implementation Plan 2013-2016.
As a first step, during a WHO mission in October 2014, the status of the national regulatory authority in Georgia was assessed using the WHO "Manual for assessment of the national regulatory system for vaccines". An updated institutional development plan (IDP) will address regulatory gaps that were identified in relation to for influenza vaccines.