As we wrap up a productive quarter, I’m pleased to share highlights of the critical work being advanced across our regulatory and prequalification activities. From accelerating access to essential vector control products to building national capacity through training and inspections, our collective efforts continue to reinforce the foundations of quality, safety and efficacy in global health.

This month’s updates showcase advances in regulatory harmonization through the CRP pilot, stronger regional collaboration, and new tools for post-market surveillance. These achievements reflect our shared vision for stronger regulatory systems worldwide. I thank you for your continued partnership and look forward to what we will accomplish together in the months ahead.

Photo: WHO

Inspection Services

WHO Prequalification (PQ) Inspection Services recently conducted a surveillance GMP inspection of a sterile antimalarial drug manufacturer in China, led by a WHO PQ inspector with support from South Africa’s regulatory authority and an observer from Indonesia’s BADAN POM/FDA. This was the first PQ inspection for the Indonesian inspector, who is part of WHO’s reinstated six-month rotational inspector fellowship programme. The initiative builds regulatory capacity by offering hands-on experience and promoting knowledge exchange. Joint inspections like this foster global collaboration, accelerate product approvals, and ensure the availability of quality-assured antimalarial medicines worldwide.

In Vitro Diagnostics

Cervical cancer remains the fourth most common cancer among women globally. In response, WHO launched a global strategy to eliminate cervical cancer, which includes screening 70% of women with a high-performance test by age 35 and again by 45. Supporting this goal, WHO has prequalified the sixth HPV assay that meets its rigorous quality standards. This milestone expands the range of quality-assured diagnostic options available to countries and helps advance the global effort to eliminate cervical cancer through earlier detection and treatment.

Medicines

WHO Prequalification of Medicines is advancing several key initiatives. A new call for medicines to treat childhood cancers will be published soon. The team also held a recent advisory meeting with a potential applicant for moxidectin to treat onchocerciasis, with future consideration for lymphatic filariasis. Two virtual trainings were announced: the 17th Annual Medicines Quality Assessment Training (9–12 June 2025) and the 4th Annual Biotherapeutic Product Assessment Training (13 June 2025). Additionally, two new draft guidelines aim to expand prequalification pathways and Collaborative Registration Procedure (CRP) use. A revised Prequalification Procedure now proposes greater reliance on approvals from WHO-Listed Authorities (WLAs) and mature regulatory systems. The revised procedure is currently under review and open for comments in advance of the upcoming meeting of the Expert Committee on Specifications for Pharmaceutical Preparations.

Immunization Devices

WHO ensures the quality and suitability of immunization devices through prequalification activities that support global immunization programmes. This includes setting performance standards based on end-user needs, verifying product compliance and publishing the IMD-PQS Catalogue for procurement and national programmes. WHO also collects field performance data and user feedback to refine product standards, encourage innovation and drive new technology development. Additionally, WHO accredits testing laboratories, assessing their facilities and capabilities to ensure immunization devices meet quality benchmarks. These efforts help ensure safe, effective and reliable immunization equipment worldwide.

Photo: WHO / N. Thomas

Vector Control Products

On 11 April, WHO prequalified SOVRENTA 15WP, an indoor residual spraying product with isocycloseram, a new active ingredient from the isoxazoline class – the first of its kind approved for public health use. This innovative chemistry offers a crucial tool in combating insecticide resistance by enabling rotational use against malaria-transmitting mosquitoes. In related efforts, the Vector Control Product team released new guidance titled “Considerations for post-market surveillance of WHO prequalified insecticide treated nets.” Developed in response to stakeholder requests, the document offers flexible guidance – not a mandate – for designing post-market surveillance tailored to specific needs and technical questions.

Regulatory Systems Strengthening

WHO recently provided in-country technical support in China to strengthen regulatory capacity through a quality management systems (QMS) training workshop, which engaged over 40 in-person and 300 virtual participants, including representatives from the National Medical Products Administration and 32 provincial regulatory authorities. Additionally, in Rwanda, a virtual WHO Coalition of Interested Parties (CIP) Network Coordination Meeting advanced the implementation of CIP support plans aligned with the Rwanda FDA’s roadmap. TRS 1054 – Annex 2 is now available in all six UN languages, offering guidance on regulatory preparedness for emergency-use vaccines. This milestone supports national regulatory authorities in building resilient systems ahead of future health emergencies.

Regulatory Convergence and Networks

WHO’s Regulatory Convergence and Networks team recently organized a training workshop on the assessment of bioequivalence studies for senior assessors from the Intergovernmental Authority on Development (IGAD) in Kampala, Uganda. The workshop aimed to strengthen national and regional medicines evaluation and registration processes by enhancing participants’ skills in reviewing bioequivalence study reports. Assessors from Djibouti, Ethiopia, Kenya, Sudan, Somalia, South Sudan, and Uganda took part. The training was jointly organized by WHO’s African Regional Office, Eastern Mediterranean Regional Office, and headquarters, together with the IGAD Medicines Regulatory Harmonization initiative secretariat, supporting ongoing efforts to build regulatory capacity across the region.

Facilitated Product Introduction

WHO’s Facilitated Product Introduction team, in collaboration with Innovation to Impact, recently held a two-day technical meeting in Istanbul to review the pilot phase of the CRP for vector control products. Launched in January 2024, the pilot aimed to accelerate regulatory approval of WHO-prequalified vector control products through collaboration with national regulatory authorities (NRAs) from Democratic Republic of Congo, Ghana, Kenya, Nigeria, Rwanda and the United Republic of Tanzania. Thirteen NRA representatives and two manufacturers contributed insights. Highlights included Ghana’s rapid registration of two products, the finalization of CRP guidelines for publication, and shared recommendations such as increased training, standardized procedures and regulatory capacity building. The meeting concluded with clear next steps for WHO, NRAs and manufacturers, marking an important milestone in strengthening regulatory systems for vector control products to fight vector-borne diseases worldwide.

Laboratory Networks and Services

The Laboratory Networks and Services team recently facilitated the successful training of two microbiology analysts from the Medicines Control Authority of Zimbabwe (MCAZ) at the Institute of Drug Quality Control of Ho Chi Minh City (IDQC-HCM). The training highlights how the WHO Global Network of Quality Control Laboratories – with Viet Nam’s IDQC-HCM and Zimbabwe’s MCAZ – serves as a valuable platform for strengthening technical capacity and fostering collaboration among national laboratories around the world.

Pharmacovigilance

Medicines and vaccines have revolutionized disease prevention and treatment, but they can also cause side effects—some unexpected or harmful. Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects or any other issues related to medicinal products. While all medicines and vaccines undergo thorough safety and efficacy testing in clinical trials, these trials involve limited, short-term use in selected populations. Some side effects may only become evident once products are used more widely over time, especially among people with diverse health conditions. Ongoing monitoring is therefore essential to ensure continued safety and effectiveness in real-world settings.

Incidents and Substandard / Falsified Medical Products

WHO recently issued an Information Notice to users of all malaria rapid diagnostic tests following reports of faint positive test lines in confirmed malaria cases. This issue affects tests for Plasmodium falciparum, P. vivax and pan species, and has resulted in misdiagnoses and delays in treatment. WHO advises that any visible test line – regardless of how faint – should be interpreted as positive. Users should adhere to proper storage and usage guidelines and ensure follow-up for patients with persistent symptoms. National programmes are encouraged to provide user training, monitor test performance and report unusual results to manufacturers.

Knowledge Management

Effective knowledge management is central to WHO’s work, supporting continuous learning, harmonization and efficiency across all regulatory activities. The Department of Regulation and Prequalifcation has invested in a range of regulatory learning approaches, including self-paced courses, instructor-led training and on-the-job learning. To build on these efforts, the department is enhancing its monitoring and evaluation frameworks to enable systematic tracking, data-driven improvements and alignment with global best practices. By embedding knowledge management into regulatory learning, product prequalification and surveillance initiatives, the department promotes collaboration, informed decision-making and continuous quality improvement – advancing its mission to strengthen regulatory systems around the world.

Quality Management Systems

A robust QMS across all departmental activities is critical to ensure consistency, transparency and continuous improvement. The 2025 QMS roadmap outlines key initiatives, including an internal audit round from May to July 2025, focusing on the implementation of newly developed standard operating procedures. Additionally, the Department of Regulation and Prequalification continues to develop a department-wide appeals handling procedure to enhance uniformity in decision-making. By embedding QMS principles across its regulatory functions, the department continues to strengthen operational efficiency, accountability and harmonization, reinforcing its commitment to high-quality regulatory practices and continuous learning.  

17th Annual Medecines Quality Assessment Training (virtual), 9-12 June 2025

I4th Annual Biotherapeutic Product Assessment Training (virtual), 13 June 2025