The purpose of this Request for Proposals (RFP) is to enter into a contractual agreement with a successful bidder and select a suitable contractor to undertake a structured technical Gap Analysis on Regulatory Systems, Standards and Oversight Mechanisms for Herbal Medicines, and Potential Implications for the WHO Global Benchmarking Tool.
The assignment will support WHO in developing an evidence informed understanding of existing regulatory approaches for herbal medicines across selected jurisdictions, identifying gaps in products-related standards and regulatory systems, and assessing whether existing WHO regulatory tools, guidance and assessment mechanisms – including the WHO Benchmarking Tool (GBT) for the evaluation of national regulatory authorities (NRAs) – adequately address regulatory considerations specific to herbal medicines. The assignment is not intended to predetermine the development of a new GBT module or tool. Rather, it will provide WHO with a technically robust basis to determine whether existing WHO frameworks and the current GBT architecture are sufficient, require interpretive guidance or targeted adaptation, or may warrant future revision in accordance with WHO governance and regulatory system strengthening processes.
WHO is an Organization that is dependent on the budgetary and extra-budgetary contributions it receives for the implementation of its activities. Bidders are, therefore, requested to propose the best and most cost-effective solution to meet WHO requirements, while ensuring a high level of service.
Overview
Traditional Medicine (TM) has played a vital role in global healthcare for centuries and remains widely used today. Member States are increasingly requesting WHO support to strengthen the quality, safety, efficacy and appropriate regulation of traditional medicine products, including herbal medicines.
Herbal medicines present specific regulatory challenges. Across jurisdictions, similar products may be regulated as medicines, traditional medicines, herbal medicinal products, foods, dietary supplements, nutraceuticals or other product categories, depending on national legislation, intended use, claims, composition and risk profile. This diversity has implications for regulatory mandates, product standards, quality assurance, safety monitoring, evidence requirements, market oversight and public health protection.
The WHO Global Benchmarking Tool (GBT) provides a structured approach for evaluating national regulatory systems, rather than individual products. Regulatory systems and relevant standards must therefore be understood before determining whether existing GBT functions, indicators and sub-indicators adequately capture the regulatory considerations relevant to herbal medicines, or whether interpretive guidance, targeted adaptation, or a future revision may be required.
Preliminary analysis suggests that several regulatory functions relevant to herbal medicines may already be reflected within the existing GBT architecture, including marketing authorization, vigilance, inspections, laboratories, licensing, regulatory oversight and market surveillance. At the same time, further technical analysis is needed to determine whether herbal medicines raise specific regulatory considerations that are not fully addressed through existing tools, standards or guidance.
A structured technical gap analysis is therefore required to:
- map selected national and regional regulatory approaches for herbal medicines;
- clarify how herbal medicines are defined and distinguished from foods, supplements, nutraceuticals and other adjacent product categories;
- identify relevant product-related standards, regulatory system requirements and oversight mechanisms;
- assess areas of alignment and divergence with existing WHO norms, standards, guidance and regulatory systems strengthening approaches; and
- provide technical options and recommendations to WHO on possible next steps, including any implications for future GBT-related work.
This assignment will support WHO decision-making. It does not, in itself, indicate a WHO position or commitment to develop, approve, or revise the existing GBT. Any future changes to the GBT or related WHO tools would be subject to WHO’s established technical, governance and consultation processes.
Documents
Deadline
Apply by 19 June 2026