The Role of the World Health Organization (WHO) in Global Regulatory 

How much do you know about WHO and the role it plays in providing access to medicines and health products? As shared by Dr Joey Gouws, the Team Lead of Inspections of the World Health Organization Prequalification Programme, during ISPE Singapore Affiliate Conference & Exhibition 2022, WHO’s vision is “A world in which all people attain the highest possible standard of health and well-being.” And the 5 priorities of Tedros Adhanom Ghebreyesus, Director General of WHO, are as follows:

1. Health for all
2. Health emergencies
3. Women, children and adolescents
4. The health impacts of climate and environmental change
5. A transformed WHO

In this article, we will focus mainly on 3 of the activities that WHO performs, as shared by Dr Joey during the conference:

1. Reacts to the needs of other UN organizations, e.g., UNICEF and Global Fund requesting technical assistance, and performs the prequalification (PQ) of medical products for UN procurement.
2. Reacts to the needs of manufacturers for technical assistance with the establishment of local production units to help member states obtain GMP compliance and GMP requirements.
3. Reacts to the needs of member states to strengthen regulatory systems, by working with NRAs (National Regulatory Authorities) in setting up the benchmark.

To have a quality product, you require all of the above 3 pointers, where a strong regulatory system is required, as well as local production and assistance.

Regarding point 1, to prequalify a product, WHO carries out the following activities:

• Performs an assessment of product dossiers (for FPPs) or master files (for APIs), QC labs, BE studies
• Inspects manufacturing/clinical sites
• Organizes the quality control testing of products
• Provides training for manufacturers, regulators and quality control labs (QCLs)
• Provides technical assistance for manufacturers and QCLs
• Develops a collaborative procedure for registration

Then, the next question will be, who can participate in the PQ procedure? According to WHO, any manufacturer of APIs/ FPPs can express an interest, if the products are eligible for assessment. This applies to both generic and innovator FPPs and can consist of one active ingredient or be that which combines several.

Figure 1: A diagram showing how WHO performs prequalification of a product

On to point number 2, following the establishment of quality products via prequalification, many countries, particularly Low-Middle Income Countries (LMICs), need guidance and support for the local production to be quality assured and sustainable. The Local Production and Assistance (LPA) unit supports Member States in strengthening sustainable local production and technology transfer to improve access to quality-assured health products in a holistic and strategic manner in collaboration with governments, partners, and other stakeholders. The LPA Unit provides the following support in the form of guidance tools, situational analyzes for sustainable quality local production, fostering partnerships to seek consensus and a global approach in strengthening local production, capacity building and specialized technical assistance to achieve quality assurance and sustainability, risk-based product selection, and facilitating technology transfer for prioritized products and technologies.

Finally to point number 3, on how WHO helps to strengthen the regulatory authorities, as this allows for sustainable quality local production.

Figure 2: WHO GBT Performance Maturity Levels

Figure 3: The ML of the WHO member states

There are 4 WHO GBT Performance Maturity Levels (ML), and the description of each maturity level is explained in the figure above. Currently, about 50% of NRAs globally have limited capacity to perform all core regulatory functions. WHO works with NRAs to establish and strengthen regulatory capacity and to assist them in achieving at least ML 3. Out of 28 countries formally assessed by WHO, Singapore is the first to have achieved the highest maturity level (ML 4) in WHO’s classification of regulatory authorities for medical products. And as per WHA67.20, WHO supports Member States upon their request in the area of regulatory system strengthening, including, as appropriate, by continuing to:

• evaluate national regulatory systems
• apply the WHO evaluation tools
• generate and analyze evidence of regulatory system performance
• facilitate the formulation and implementation of institutional development plans
• provide technical support to national regulatory authorities and governments

With WHO’s efforts in prequalification, local production and regulatory system strengthening, the following benefits for the manufacturers can be achieved:

• Speed up the attainment of WHO Prequalification (PQ) or Emergency Use Listing (EUL)
• Build capacity to understand and meet WHO quality assurance standards
• Improve the quality of products manufactured at the facility
• Promote regulatory convergence, harmonization, greater collaboration, work sharing and reliance mechanisms amongst regulators.

The benefits that can be achieved for UN agencies and international procurement agencies include an enlarged range of PQ products for procurement and diversified supply sources of quality health products.

Following the talk by Dr Joey on the role of the World Health Organization in global regulatory, there was an ASEAN Regulatory Roundtable: The Future of Pharmaceutical Inspections, which was moderated by Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, Australia. The panellists were asked to share their opinions on various questions, and we have brought you their answers in another article about the future of pharmaceutical inspections.

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