WHO drafts recommendations for regulatory reliance

Regulatory NewsRegulatory News | 09 June 2020 |  By 

The World Health Organization (WHO) this week began a public consultation on a set of principles and recommendations for good reliance practices (GRelP) in regulatory decision-making aimed at increasing efficiency and allowing regulators to focus their efforts on critical activities.
The draft guideline applies to regulatory activities for a range of medical products, including drugs, vaccines, blood/blood products, medical devices and in vitro diagnostics, and covers the total product lifecycle for those products.
“This principle enables leveraging the output of others whenever possible while placing a greater focus at the national level on value-added regulatory activities that cannot be undertaken by other authorities, such as in-country vigilance activities and oversight of local manufacturing and distribution,” WHO says, noting that, “Regulatory systems can be very resource-intensive.”
The draft guideline follows a meeting in September 2019 that identified the Pan American Health Organization (PAHO) and Pan American Network for Drug Regulatory Harmonization (PANDRH) concept note and recommendations “as a starting point” for the development of the current document.
“[National regulatory authorities] must consider enhanced, innovative and more effective forms of collaboration in order to make the best use of the available resources and expertise, avoid duplication and concentrate their regulatory efforts and resources where most needed,” WHO says.
WHO also says its ongoing initiative to designate national regulators as WHO-listed authorities (WLAs) based on their performance and maturity level could be used as a “globally recognized, evidence-based and transparent system that can be used by [national regulatory authorities] as a reference to practise reliance.”
Within the guideline, WHO details a number of approaches to reliance, including joint assessments, unilateral and mutual recognition, abridged regulatory pathways and work-sharing arrangements.
Credit: World Health Organization
The principles are not exclusive to lower resource settings, as evidenced by efforts such as the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), the US Food and Drug Administration (FDA) and European Medicines Agency’s (EMA) mutual recognition  agreement for good manufacturing practice (GMP) inspections and FDA’s Project Orbis, which involves the collaborative review of cancer treatments by several international regulators. Other examples of reliance or work-sharing initiatives include the EU’s Voluntary Harmonization Procedure; the African Vaccine Regulatory Forum; the EU’s “Article 58” and Swissmedic’s marketing authorization for global health products procedures; and the WHO’s own Collaborative Registration Procedure and prequalification program.
“This document is intended for all [national regulatory authorities], irrespective of their level of maturity or resources, as well as policy makers, governments, the industry and other developers of medical products,” WHO says.
The document also addresses barriers that could hinder efforts to institute reliance measures, such as the lack of political will or government support and a lack of information to base reliance decisions on.
WHO stresses that, “Reliance does not represent a less stringent form of regulation nor an outsourcing of regulatory mandates or a compromise to independence. On the contrary, the decision to ‘regulate through reliance’ is the hallmark of a modern and efficient regulatory authority.”


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