The World Health Organization (WHO) began assessing regulatory systems in 1997, using a set of indicators designed to analyze regulatory programs for vaccines. Several tools and revisions were later introduced. The WHO Global Benchmarking Tool for evaluation of national regulatory systems of medical products (Revision VI) replaces all the tools previously used by WHO for evaluating regulatory systems.

The purpose of the tool is to evaluate the overarching regulatory framework and the regulatory functions that compose it: national regulatory system, registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, and NRA lot release, through a series of sub-indicators that may also be grouped and examined according to nine cross-cutting categories, for example, quality and risk management system.

Documents

herramientas para evaluar productos medicos

WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory Systems of Medical Products

The designation National Regulatory Authority of regional reference recognizes the installed regulatory capacities in the Region, and aims to promote the exchange of information on the regulation of medicines and biological products between countries, while also helping to strengthen other NRAs. An NRAr has the installed technical and organizational capacity to promote further strengthening of regulatory capacities in the Region of the Americas

List of national regulatory authorities of reference

In the context of PAHO Resolution CD50.R9 (2010), NRAr resolve to continuously improve regulatory processes, and commit to collaboration and joint efforts that promote sustainable models over time.

Thus, the essential areas in which NRArs contribute include:

Sharing experiences of their regulatory practices
Proactively participating in technical cooperation programs and other activities of interest within and outside the Region
Participating in international forums and disseminating the NRAr evaluation model in other regions

An ongoing WHO initiative that aims to establish and implement a framework for assessing and designating national regulatory authorities (NRAs) that meet a defined criteria as WHO-listed authorities (WLAs). The designation of a regulatory authority as a WLA is ultimately intended to promote access to and supply of safe, effective, and quality medicines and vaccines. With the introduction of the WLA designation, WHO will replace (i) the concept of Stringent Regulatory Authority (SRA), which was a pragmatic approach developed by WHO, without any prior evaluation, to guide the global procurement of medicines; and (ii) the concept and procedure for recognition of regulatory authorities that exhibit ‘a high level of performance’ in the regulation of vaccines (known at the time as ‘functional NRAs’). As the first global tool for evaluating regulatory systems based on inputs, processes, and outputs, following standardized objective criteria, the WHO Global Benchmarking Tool (GBT) remains the basis for this activity. Additional information and links to provisional lists of national regulatory authorities

Additional information and links to provisional lists of national regulatory authorities

The GBT also incorporates the concept of ‘maturity level’ or ML(adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 to 4.

Vigilance module (VM)

In theGBT, pharmacovigilance is addressed in Module 3 as part of thevigilance function. Vigilance of medical products––defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medical product‐related problems––is extremely important for guaranteeing that safe and effective medical products of high quality are used in the country.

The following diagram provides the indicators and sub-indicators of the vigilance module that correspond to each maturity level. (Clicking on each level displays the corresponding indicators and sub-indicators.)

VL04 Procedures established and implemented to perform vigilance activities.

Sub indicators:

VL04.03: Standard procedures exist and are implemented for enforcement of the national vigilance system.
VL04.07: With respect to vigilance data, assessment of the risk-benefit balance of medical products is regularly conducted.
VL04.08: Active vigilance activities, as well as proactive monitoring programmes (when needed) have been developed and implemented.

VL05 Mechanism in place to monitor regulatory performance and output.

Sub indicator:

VL05.02: Performance indicators for vigilance activities are established and implemented.

VL01 Legal provisions, regulations and guidelines required to define regulatory framework of vigilance

Sub indicator:

VL01.05: Legal provisions, regulations and guidelines require manufacturers and/or MAHs to designate an individual person to be in charge of vigilance system.
VL01.06:There are guidelines for planning, conducting, monitoring, and reporting of vigilance activities.

VL02: Arrangement for effective organization and good governance.

Sub indicator:

VL02.02: Documented procedures and mechanisms are implemented to ensure the involvement, coordination and communication among all stakeholders relevant to vigilance activities

VL03: Human resources to perform vigilance activities.

Sub indicators:

VL03.02: Duties, functions, and responsibilities of the staff in charge of vigilance activities are established and updated in the respective job descriptions.
VL03.04: The NRA generates and maintains records of staff training activities and training effectiveness verification.

VL04: Procedures established and implemented to perform vigilance activities.

Sub indicators:

VL04.01:Vigilance procedures and tools are in place and implemented for collection and assessment of adverse drug reactions (ADRs) and adverse events (AEs).
VL04.02: Vigilance procedures and tools are in place for investigation, interpretation of and response to ADRs and AEs.
VL04.04: Risk approach is considered throughout different vigilance activities, including timely response to detected signals for risks or benefits
VL04.06: The NRA has access to expert committees for review of serious emergent safety concerns, when needed.

VL05: Mechanism in place to monitor regulatory performance and output.

Sub indicator:

VL05.01: Vigilance information is used in timely manner to amend existing regulatory decisions or to issue new regulatory decisions or actions.

VL06: Mechanism exists to promote transparency, accountability and communication.

Sub indicators:

VL06.01: Vigilance activities and relevant feedback are appropriately communicated to the public.
VL06.02: Mechanism for regular feedback to all stakeholders on vigilance events exists and is complemented with a risk communication plan.
VL06.03: Vigilance data and findings are shared with relevant regional and international partners.

VL01: Legal provisions, regulations and guidelines required to define regulatory framework of vigilance.

Sub indicator:

VL01.04: Legal provisions and regulations allow NRA to require manufacturers and/or MAHs to conduct specific studies on safety and effectiveness under specific conditions.

VL02:Arrangement for effective organization and good governance.

Subindicador:

VL02.01: There is a defined organizational structure with clear responsibilities to conduct vigilance activities

VL01: Legal provisions, regulations and guidelines required to define regulatory framework of vigilance.

Sub indicators:

VL01.01: Legal provisions for a national vigilance system exist.
VL01.02: Legal provisions and regulations require the manufacturers and/or MAHs to set up a vigilance system of their medical products and periodically report vigilance data to the NRA.
VL01.03:Guidelines ensure that distributors, importers, exporters, healthcare institutions, consumers and other stakeholders are encouraged to report adverse drug reactions (ADRs) and AEs to the Marketing Authorization Holder (MAH) and/or National Regulatory Authority (NRA).
VL01.07: Legal provisions and regulations allow recognition and/or reliance on vigilance-related decisions, reports or information from other countries or regional or international bodies.

VL04: Procedures established and implemented to perform vigilance activities.

Sub indicator:

VL04.05: Staff access to information resources relevant to vigilance processes (e.g., safety information sources and reference materials) is ensured.

Country experiences

GBT Vigilance Module – Review Activity in the Region

The review of the GBT VigilanceModule was carried out in 2021 with the participation of six countries of the Region (Costa Rica, El Salvador, Honduras, Panama, Paraguay, and Peru).

The objectives of the activity were to: provide training in the use of the GBT platform and tool; manage the platform for exchanging evidence; become familiar with detailed technical files; develop narratives; and generate evidence to determine the degree of implementation.

Country representatives were assisted in conducting a self-assessment of the vigilance module, prioritizing key indicators.

*I: Implemented
*PI: Partially implemented
*OI: Ongoing Implementation
*NI: Not implemented

Quality control of medicines

Back to Pharmacovigilance

The WHO global benchmarking tool (GBT)

Vigilance module (VM)

Country experiences

GBT Vigilance Module – Review Activity in the Region