WHO contributes to strengthening Bulgaria's vaccine regulatory system

From 1 to 4 October 2012 WHO will conduct a reassessment of Bulgaria's national regulatory authority (NRA) responsible for the regulatory oversight of vaccines. This is a key and mandatory step in the WHO vaccine prequalification procedure.

The main objectives are twofold: to determine whether the vaccine regulatory system, represented by the Bulgarian Drug Authority (BDA), continues to satisfy WHO NRA indicators in the area of vaccines, and to update the NRA Institutional Development Plan (IDP), including a training plan to address existing and/or potential gaps and build upon the strengths of the existing system.

During the previous assessment conducted in 2001, the national regulatory system of Bulgaria was declared "functional" as per assessment performed using the WHO established indicators.

Outcomes

The expected outcomes of the reassessment are:

• a draft assessment report of the regulatory functions in Bulgaria with documented status of the NRA as either "functional" or "not functional" as per WHO NRA published indicators; 
• a detailed NRA IDP including a training plan; 
• presentation of the findings to the national authorities and the WHO Country Office, including discussions to update or amend the final score of the indicators if needed; 
• a draft report including a detailed and updated IDP and training plan as well as the status of the assessed NRA functions to be discussed on the last day of assessment; 
• a presentation summarizing the findings and recommendations to be handed to the national regulatory authorities; 
• a full report to be delivered by WHO within six weeks after the assessment.

The WHO NRA assessment is organized and conducted in accordance with the Quality Management System (QMS) principles and follows the relevant guidelines and manuals available for this purpose.