Welcome to the February issue of the RPQ update, highlighting our work to ensure access to safe, effective and quality-assured health products that are crucial for universal health coverage. We help strengthen national regulatory authorities by providing guidance, building regulatory capacity and establishing international norms. Through prequalification, we aim to ensure medicines, vaccines and other health products for supply to low- and middle-income countries are quality-assured, safe, effective and accessible to all populations.

February saw important debates on the future of access to quality-assured, safe and effective health and medical products. Strengthening regulatory systems in Africa is a significant step forward. Operationalization of the African Medicines Agency (AMA), establishment of operationalization mechanisms for reliance between recent Maturity Level 3 (ML3) National Regulatory Authorities (NRAs), and continuation of work towards the WHO Listed Authorities (WLA) Framework are also important components to support future innovation on global and regional procurement policies. We are also designing an innovative pilot project with the South African NRA (SAHPRA) for joint vaccines assessment, that aims to reinforce reliance mechanisms in the future.

Attaining ML3 status for vaccines is considered an essential prerequisite for vaccine prequalification. However, only Prequalification or WLA designation can ensure the long-term self-sufficiency of national and regional regulatory systems, thereby meeting internationally recognized procurement requirements.

Meanwhile, these significant efforts continue to be tested by persistent challenges, including substandard and falsified products, the need for robust global pharmacovigilance to support market control and surveillance, and ongoing enforcement of Good Manufacturing Practices (GMP) inspections – all vital to effective regulatory oversight.

I invite you to read on for more updates and insights in this edition.

Inspection Services

In January 2025, Inspection Services conducted 19 inspections to ensure compliance at manufacturing sites for WHO prequalified pharmaceuticals, active pharmaceutical ingredients, vaccines, in-vitro diagnostics, vector control products, clinical research organizations and quality control laboratories. Additionally, the service relaunched its fellowship programme for rotational inspectors from Rwanda and Indonesia as part of ongoing efforts to strengthen national medicines regulatory authorities. This programme offers valuable capacity development through hands-on experience with WHO GMP inspections, ultimately enhancing technical skills and improving access to medical and health products.

Photo: WHO

In Vitro Diagnostics

A workshop for in vitro diagnostics manufacturers based in Asia was held from 20–22 January in Jakarta, Indonesia, with over 150 participants from eight countries in attendance. The event provided insights into ongoing projects in the WHO South-East Asia and Western Pacific regions, WHO testing guidelines across diseases, donor perspectives on access and local manufacturing, current quality assurance policies, WHO risk-based assessments of in vitro diagnostics, prequalification processes, health technology transfer and manufacturer support projects. It also helped identify needs for future information sessions, and participants and speakers engaged in lively discussions on the topics presented.

Photo: WHO

Medicines

In 2024, Medicines achieved major milestones, a few of which include the prequalification of 48 finished products and 21 APIs, with a median WHO processing time of 180 days. Another 72 products were requalified, and 400 variation applications met performance targets. Advisory meetings were held with companies utilizing the innovative human-insulin Master File (h-IMF) procedure, and capacity building activities included trainings for regulators with 250 participants and workshops for manufacturers with 300 participants. In the annual joint UNICEF-UNFPA-WHO manufacturer meeting, Medicines conducted 31 one-on-one sessions with manufacturers and other key stakeholders.

Photo: Stock image

Vaccines and Immunization Devices

On 6 February 2025, new WHO Public Assessment Reports (WHOPARs) were released. In addition, the Vaccines team published the revised zinc expression of interest on 10 February 2025. The WHO Immunization Devices Performance, Quality & Safety Catalogue of Prequalified Devices (IMD-PQS) is also available for download on the website.

Vector Control Products

PQT/VCP began 2025 preparing for an influx of applications from insecticide-treated net manufacturers in response to the implementation plan for the WHO Guideline for Prequalification of Insecticide-Treated Nets. An additional assessment session, a Quality Convening, was hosted in Geneva, Switzerland for efficient initiation of assessments in advance of the full ASVCP meeting in Manila, Philippines in March. For the submitted responses, PQT/VCP has completed 22 technical screening actions in an average time of 13 days. We appreciate and want to thank manufacturers for their engagement in this process.

Photo: WHO PAHO

Regulatory Systems Strengthening

Egypt has reached WHO’s ML3 in medicines regulation, building on its 2022 achievement for vaccines and marking it as the first African nation to attain ML3 for both. The Egyptian Drug Authority secured this milestone through a WHO benchmarking process completed in November 2024, strengthening its regulatory system and global health role. Meanwhile, a new report, developed with input from Regulatory Systems Strengthening, proposes a stepwise approach to address antibiotic shortages in low- and middle-income countries as part of the SECURE initiative by GARDP and WHO.

Photo: WHO

Regulatory Convergence and Networks

WHO is committed to strengthening global regulatory capacity for medical product oversight through international cooperation, including regulatory convergence, harmonization, reliance, and recognition. The Regulatory Convergence and Network team supports Member States by fostering collaboration within regional and international networks, ensuring more efficient and effective regulation worldwide.

Photo: Stock image

Facilitated Product Introduction

RPQ is pleased to announce the registration of a second VCP through the Collaborative Registration Procedure (CRP) for pilot. The NRA of Ghana (Food and Drugs Authority, FDA Ghana) completed the regulatory decision in just 42 days. The first product registered under the CRP for VCPs was also approved by FDA Ghana in a record 28 days. Launched in January 2024 with six participating countries in Africa, the CRP streamlines VCP registration through voluntary agreements between NRAs and manufacturers. By leveraging WHO prequalification assessment reports, NRAs can aim for a decision within 90 working days, ensuring faster access to essential products. These two successful registrations underscore the CRP’s effectiveness in accelerating national approvals.

Photo: WHO

Laboratory Networks and Services

The Laboratory Networks and Services team welcomes Viet Nam’s National Drug Quality Control Laboratory (NDQCL) and the Institute of Drug Quality Control (IDQC) as full members of the WHO Global Network of National Quality Control Laboratories for Pharmaceuticals (WHO-GNP). Following successful participation as an observer at the 6th General Meeting of the WHO National Control Laboratory Network for Biologicals (WHO-NNB), the Supreme Board for Drugs & Medical Appliances of Yemen has also joined as an associate member of the WHO-NNB. Their inclusion strengthens collective efforts to ensure the availability of safe, quality-assured medical products.

Photo: WHO

Pharmacovigilance

Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and/or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.

Photo: WHO

Incidents and Substandard / Falsified Medical Products

Tackling substandard and falsified medical products (SFMPs) is a priority. At the 156th WHO Executive Board (EB156), Member States underscored the growing threat of SFMPs, which endanger patients and weaken health systems, especially in low- and middle-income countries. Recent cases of contaminated medicines highlight the urgent need for stronger safeguards (EB156/11). The WHO Member State mechanism remains vital but needs greater engagement and sustainable funding. Many countries support reforms to boost effectiveness while maintaining its core structure. Stronger regulations, surveillance, and global cooperation are essential. Countries called for more reporting to WHO’s Global Surveillance and Monitoring System, enhanced regional partnerships and innovative digital tools. 

Photo: WHO / Sergey Volkov

Knowledge Management

Launch of WHO RPQ learning activities - Monitoring and Evaluation framework
RPQ has invested significantly in regulatory learning – spanning self-paced courses, instructor-led sessions and on-the-job training. Aligning with the WHO Fourteenth General Programme of Work’s strong commitment to monitoring and evaluation, RPQ is introducing a new Monitoring and Evaluation Framework for its regulatory learning activities. This framework builds on current RPQ systems and practices, ensuring harmonization and continuous improvement through a comprehensive, systematic approach. It provides a clear structure for ongoing monitoring, data-driven refinements and enhanced quality and performance.

Photo: WHO / Henitsoa Rafalia

Quality Management Systems

The departmental QMS Roadmap is available and includes the 2025 internal audit round. It is part of RPQ’s continuous improvement programme and will be conducted from May to July 2025. This round of internal audits will focus on the implementation of newly developed standard operating procedures. In addition, the team is developing a uniform, department-wide appeals handling procedure to further enhance the consistency and transparency of the department’s decision-making processes.

Photo: AI-generated image