As we wrap up the year, this RPQ Update provides an update on our progress and highlights key initiatives that have defined our work. WHO continues to close the year with a focus on collaboration, working closely with partners to drive meaningful change in global health.

Our recent joint meeting in Copenhagen with UNICEF, UNFPA, manufacturers and suppliers exemplified the power of these partnerships. It was not only a chance to share critical information with stakeholders but also an invaluable opportunity to engage in dialogue. UN staff across various areas came together with stakeholders to exchange experiences, share knowledge, and strengthen the foundation for future collaboration. Key highlights of this meeting included updates on progress on establishing new innovative prequalification practices, initiating discussions on how we can look at the way we work to ensure the sustainability is emphasized and updates on initiatives in place to strengthen supply chains. More about this meeting will be shared in January.

As we look ahead, I am confident that our collective efforts will continue to advance health equity and ensure access to quality health products for all. Wishing you a joyful holiday season and a Happy New Year filled with success, collaboration and impactful work. Together, we can achieve even greater milestones in the year to come!

Inspection Services

WHO Inspection Services attended the 2024 PIC/S meeting in Brasília, focusing on pharmaceutical inspection advancements, collaboration, and regulatory harmonization. Key highlights included discussions on best practices, sterile manufacturing training, and improving access to online resources for inspectors. INS also conducted inspections of five National Quality Control Laboratories in South America (FUNED and LACEN-GO in Brazil, CONCAMYT in Bolivia, INVIMA in Colombia, and CCCM in Uruguay) and met with government and Pan American Health Organization representatives. These efforts emphasized the importance of laboratory prequalification in ensuring medicine quality, safety and efficacy, particularly in low- and middle-income countries.

Photo: WHO

In Vitro Diagnostics

On 2 December 2024, WHO prequalified the first test for tuberculosis (TB) diagnosis and antibiotic susceptibility testing, marking a major step in improving TB control. In addition, in collaboration with the WHO Global TB Programme, RPQ is working to enhance access to quality-assured TB tests and broaden diagnostic options for countries. WHO is also evaluating seven additional TB tests, reinforcing its commitment to expanding diagnostic capabilities and ensuring effective treatment for TB globally.

Photo: WHO / Khasar Sandag

Medicines

• As of 2 December 2024, WHO prequalified 43 medicines (including two tafenoquine products aligned with updated malaria guidelines) and 20 active pharmaceutical ingredients (APIs) and requalified 66 products.
• The HIV/AIDS EOI added lenacapavir.
• The 142nd assessment session brought together over 70 experts from Africa, South America and Asia.
• Aware of rifampicin shortages, WHO is prioritizing API approvals and proactively engaging with manufacturers to address nitrosamine-related testing and risk mitigation strategies.

Photo: Stock image

Vaccines and Immunization Devices

• In December 2024, WHO prequalified its 12th vaccine of the year, the BCG vaccine, recommended for routine infant immunization to prevent TB. Additionally, WHO endorsed Extended Controlled Temperature Conditions (ECTC) for MenFive™ [Meningococcal ACYWX (conjugate) vaccine], reducing logistics costs in challenging settings.
• WHO also issued guidelines for stability evaluation under ECTC, distinguishing regulatory requirements from CTC programme aspects. Vaccines under ECTC must specify approved conditions on packaging, enhancing efficiency and accessibility in vaccine distribution.
• A WHO workshop in the United Arab Emirates convened 82 participants from 19 Member States and global stakeholders to discuss risk-benefit assessments for snake antivenoms. These assessments aim to improve regulatory management of 27 critical products, addressing snakebite envenoming, a neglected disease responsible for 80 000–140 000 deaths annually.

Photo: WHO

Vector Control Products

WHO Vector Control Products, with the Pan American Health Organization (PAHO) and WHO Brazil, held an engagement day to discuss vector control product regulation, data gaps and priorities in the Americas. Representatives were present from PAHO, OPAS Brazil, ANVISA and Brazil’s Ministry of Health. They enhanced understanding of PAHO/OPAS procurement and support mechanisms, VCP processes, ANVISA regulations and Brazil’s vector control programmes. Participants pledged ongoing collaboration to strengthen supply, quality assurance and oversight of novel vector control products in the region.

Photo: WHO

Regulatory Systems Strengthening

• Senegal and Rwanda have achieved WHO Maturity Level 3 (ML3), ensuring international-quality medicines and advancing healthcare in Africa. This milestone supports universal health coverage, Sustainable Development Goal 3 and fosters a harmonized regulatory landscape across the continent.
• WHO’s updated Global Benchmarking Tool Plus Medical Devices (GBT+MD) strengthens national regulatory systems for medical devices, addressing unique challenges with six regulatory functions, a glossary, and a fact sheet. These advancements highlight collaboration and innovation in ensuring global health and patient safety.

Photo: WHO

Regulatory Convergence and Networks

The WHO Paediatric Regulatory Network’s annual meeting convened in Istanbul, Türkiye, on 18–19 November 2024, fostering international collaboration for timely paediatric medicine registration. Attendees shared technical initiatives, collaborative frameworks, capacity-building, and training opportunities to ensure high-quality, safe and effective treatments for children. Updates on WHO-Listed Authorities were discussed, and participants explored ways to leverage the Network’s expertise and global network. The meeting highlighted the importance of strengthened cooperation across regions to address regulatory challenges in paediatric medicines.

Photo: WHO

Facilitated Product Introduction

• WHO is advancing regulatory processes with impactful initiatives. On 25 November 2024, the WHO Emergency Use Listing Facilitated Procedure expedited national approval of Mpox diagnostics, streamlining regulatory actions and enhancing access.
• The 12th WHO Collaborative Registration Procedure Meeting in Jakarta gathered over 100 participants to share best practices and pilot innovations for regulatory reliance.
• The 3rd ASEAN Joint Assessment Advocacy Meeting reviewed progress, fostering collaboration, feedback, and advocacy to improve access to quality-assured medical products across the region.

Photo: WHO / Felix Marquez

Laboratory Networks and Services

The Laboratory Networks and Services Team, in collaboration with the Egyptian Drug Authority, hosted the 6th WHO-NNB Meeting in Cairo, Egypt. It gathered 120 participants from 58 countries under the theme "Reliance through Transparency and Trust." Attendees shared knowledge, best practices and updates. Collaborative efforts focused on harmonizing regulatory approaches, fostering reliance and improving vaccine quality monitoring. WHO, WHO-NNB members and partners highlighted global efforts to further strengthen regulatory capacity and ensure consistent standards in vaccine production and release globally.

Photo: WHO

Pharmacovigilance

WHO Pharmacovigilance Partners’ Meeting took place in New Delhi, India on the margins of the 19th International Conference of Drug Regulatory Authorities (ICDRA). In total, 147 people from 68 countries participated in this face-to-face meeting. Following presentations on country and regional perspectives, attendees reviewed concepts focusing on lessons learned, a risk-based approach, prioritization, work-sharing, reliance, and integration of pharmacovigilance into overall regulatory strengthening. The feedback will guide revisions of the Strategy, which will then be shared with participants and WHO Member States for further comments and insights.

Photo: WHO

Incidents and Substandard / Falsified Medical Products

• WHO has issued an alert on falsified USP/EP Propylene Glycol  contaminated with ethylene glycol in Pakistan, posing severe health risks and urging stricter quality controls.
• A new WHO report highlights a rise in substandard and falsified medicines, emphasizing vigilance in low- and middle-income countries.
• The 13th Meeting of the Member State Mechanism on Substandard and Falsified Medical Products meeting reviewed progress on regulatory capacity and traceability while addressing global challenges, including falsified opioids. Strategic recommendations were endorsed, reaffirming the need for collaboration to ensure medical product safety.

Knowledge Management

On December 17, WHO Academy’s new Lyon campus becomes WHO’s primary learning hub, migrating all courses to its innovative Learning Experience Platform. Starting in 2025, WHO health product regulation e-learnings won’t be on OpenWHO.org anymore. To ensure you retain your progress, we encourage you to complete any ongoing courses and download your certificates by December 31, 2024. Stay tuned for future updates and learning opportunities from the WHO Academy!

Photo: WHO / Genna Print

Quality Management Systems (QMS)

Quality assurance staff have rolled out the departmental QMS Roadmap. This includes scheduling the 2025 internal audit round that 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