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India’s Vaccine Regulatory System Declared ‘Functional’ by WHO.

The WHO conducts a detailed evaluation known as Global Benchmarking Tool (GBT) assessments to determine whether a country’s national regulatory authority (NRA) is capable of functioning effectively across various health product categories, including vaccines.

When WHO declares a regulatory system ‘functional,’ it means that the country’s National Regulatory Authority (NRA) has the necessary infrastructure, processes, standards, and expertise in place to regulate vaccines in line with global norms.

About GBT:

The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems on Regulatory System Strengthening for medical products.

The tool and benchmarking methodology enable WHO and regulatory authorities to:

WHO began assessing regulatory systems in 1997 using a set of indicators designed to evaluate the regulatory programme for vaccines. Since that time, a number of tools and revisions were introduced. The GBT replaces all tools previously used by WHO, representing the first truly ‘global’ tool for benchmarking regulatory systems.

The GBT is designed to evaluate the overarching regulatory framework and the component regulatory functions (e.g. clinical trial oversight) through a series of sub-indicators

The GBT also incorporates the concept of ‘maturity level’ or ML, allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 (existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement).

India's National Regulatory Authority (NRA) has achieved Maturity Level 3 (ML 3) for some functions under the World Health Organization (WHO) Global Benchmarking Tool (GBT). India's regulatory authority has maintained this level despite more stringent criteria in the updated GBT Version VI.

The GBT is designed to benchmark the regulatory programmes of a variety of product types, including medicines, vaccines, blood products (including whole blood, blood component and plasma derived products) and medical devices (including in vitro diagnostics). 

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