Strengthening regulatory capacity: a 10 year review of progress, revision of National Regulatory Authority benchmarking system and a look to the future.
The Quality, Safety and Standards (QSS) team held a meeting on "Strengthening vaccine regulatory capacity: a 10-year review of progress, revision of NRA benchmarking system and a look to the future" at WHO/HQ in Geneva from 17 to 19 December 2007.
WHO has developed an assessment tool for evaluation of the regulatory system and six critical functions of the national drug regulatory process, with special reference to the evaluation of vaccines. This activity aims at helping both WHO and the concerned national regulatory authorities (NRAs) to identify gaps and strengths, priority areas for development, training, and technical advice as well as potential support that can be implemented through an institutional development plan (IDP).
The work carried out from 1997 to 2000 concerned primarily the review of national capacity to regulate and control vaccines. In 2001 the two WHO teams responsible for regulatory support at that time, Access To Technologies of the Immunization, Vaccines and Biologicals Department (ATT/IVB) for vaccines and the Team of Quality Assurance and Safety: Medicines, Department of Essential Drugs and Medicines Policy (QSM/EDM) for non-biological drugs, established a joint initiative, based on the fact that in most countries there is only one national authority to regulate medicines and that substantially similar regulatory procedures are used for vaccines and other products.
Through this initiative, joint ATT/QSM reviews were conducted for both vaccines and drugs until 2002. The work done so far has enabled both teams to identify ways to document the existing gaps in national regulatory authorities and outline strategies necessary for addressing these gaps.
It is now intended to review the experiences, achievements and constraints in the assessment of the national regulatory system for vaccines, to propose revision of the methodology of work regarding NRA assessments and the data collection tool, with special reference to functions and indicators, and to address future developments and unmet needs particularly human resources and institutional capacity development.