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Abstract:
In light of recent global health challenges, the need for regulatory reliance — where one regulatory authority accepts the decisions of another — has gained significant interest and momentum. A fundamental role of any government is to protect its citizens and promote a healthy lifestyle by ensuring the quality, safety, and efficacy of medical products. This task can be challenging for governments, national regulatory authorities, and inspectorates due to shortages of competent staff, inadequate resources, and varying levels of political and regulatory will.
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as ‘the attainment by all peoples of the highest possible level of health’. Headquartered in Geneva, Switzerland, it has six regional offices and 150 field offices worldwide.
The WHO Prequalification Programme, established in 2001, is a service provided by WHO to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis. From the outset, the Programme has been supported by the Joint United Nations Programme on HIV/AIDS (UNAIDS), United Nations International Children’s Emergency Fund (UNICEF), United Nations Population Fund (UNFPA), and the World Bank as a concrete contribution to the United Nations’ priority goal of addressing widespread diseases in countries with limited access to quality medicines.
According to WHO, in good reliance practices in the regulation of medical products: high-level principles and considerations (TRS 1033, Annex 10):
Regulatory reliance is an act by the National Regulatory Authorities (NRAs) around the globe to take into account the outcome of a regulatory decision from a competent authority before reaching their own decision to approve or reject certain applications for marketing authorizations.
Regulatory recognition is a process whereby a regulatory decision is made by an NRA based on the evidence of conformity provided by another competent and matured NRA, without reinventing the wheel (WHO TRS 1019, Annex 6).
This paper reviews and evaluates initiatives undertaken (from 1980) by various NRAs and regional and international organizations to leverage regulatory reliance and regulatory recognition to harmonize regulatory decisions and expedite the regulatory approval process.
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Submitted: 18 March 2024; Revised: 28 October 2024; Accepted: 4 November 2024; Published online first: 18 November 2024
Introduction
National Regulatory Authorities (NRAs) work under tremendous pressure to facilitate timely access to safe, effective, and good-quality health products worldwide. The global COVID-19 pandemic has exacerbated this pressure, making the task of ensuring timely access to health products more challenging due to the increasing complexities of products, processes, and technologies, including outsourcing activities such as contract manufacturing, batch release testing, qualification and validation, clinical trials, and more.
This paper explores two strategies used by NRAs to ease this burden, namely:
- Regulatory Reliance [1]
- Regulatory Recognition [2]
According to the World Health Organization (WHO), Good reliance practices in the regulation of medical products: high level principles and considerations (TRS 1033 — Annex 10) [1]:
Regulatory reliance is an act whereby a regulatory authority in one jurisdiction may take into account or give significant weight to work performed by another regulator or other trusted institution when reaching its own decision.
Regulatory recognition is the routine acceptance of the regulatory decisions of another regulator or other trusted institution. Recognition indicates that evidence of conformity with the regulatory requirements of country A is sufficient to meet the regulatory requirements of country B.
If an NRA wishes to rely on the outcome of a certain decision or approval of health products or marketing authorization made by other NRA, trust is the only prerequisite for reliance. Building trust and establishing confidence are the starting points for reliance and recognition.
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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.
