The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity

Abstract

Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regulatory capacity for medicines and vaccines. The GBT is a game changer because it is the first globally accepted tool for assessing and strengthening national regulatory authorities. The inclusion of an institutional development plan in the GBT methodology provides context-specific actionable steps countries can take to advance their system’s functionality and maturity. The GBT facilitates coordination and improves the effectiveness of regulatory strengthening efforts. The tool also facilitates regulatory reliance and harmonisation, which helps to improve timely access to quality-assured medicines, and creates incentives for trade, particularly in countries and regions with a strong pharmaceutical manufacturing base. The GBT is a necessary tool for creating strong and effective regulatory systems, which are critical for ensuring the efficacy, safety and quality assurance of medicines and populations’ timely access to these medicines. In outlining the benefits of the GBT, this paper also offers some specific ideas for strengthening the GBT framework and process.

Potential negative impact of reputed regulators’ decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis

“…However, the governing axiom of early access to any new oncologic drug is jeopardizing the in-depth and careful evaluation of new medicines worldwide, with enormous consequences to low and middle income countries. Reliance may foster cooperation and resource optimization [ 52 , 53 ] but it may also induce loss of national control over approvals of doubtful new medicines, and promote quick approvals where the capacity to monitor or withdraw MA when new contrasting evidence emerges is almost nonexistent [ 15 ].…”

Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles

“…WHO coordinated the development of an up-to-date global set of indicators using existing WHO, Indicator-Based Pharmacovigilance Assessment Tool (IPAT) and Global Benchmarking Tool (GBT) indicators, to assess PV preparedness of a country for the introduction of a new pharmaceutical product [ 11 , 12 ]. Baseline assessments of the PV infrastructure, competence, capacity and gaps in four of the target countries took place during scoping visits (prior to 3S implementation): Armenia (March 2018), Ethiopia (February 2019), India (July 2018), Thailand (March 2019).…”

Strengthening regulatory systems for medicines in a changed world: where do we go from here?

“…Over the past several decades, great strides have been made to strengthen regulatory systems across the globe. For example, greater harmonisation of technical standards via The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, 1 adoption of WHO initiatives such as Good Regulatory Practices 2 and the Global Benchmarking Tool, 3 greater use of digital tools and more international cooperation and collaboration–including regulatory reliance mechanisms—between regulatory authorities. These initiatives are essential because strong regulatory systems streamline the regulatory review and approval process, facilitating access to safe and effective medicines to patients.…”

“…These initiatives are essential because strong regulatory systems streamline the regulatory review and approval process, facilitating access to safe and effective medicines to patients. 3 Never has this endeavour felt more critical.…”