Welcome to the May 2024 edition of this newsletter, where we bring you the latest news, events and achievements from our Regulation and Prequalification (RPQ) Department as we strive to improve access to safe, effective and quality-assured medicines around the world.

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Recent highlights

Transformative expansion of the WHO-Listed Authorities Framework

WHO has designated 33 new national and regional regulatory authorities as WHO-Listed Authorities (WLAs) – a tenfold increase in WLAs since three authorities received WLA status in October 2023. These institutions can be relied on to fulfil the highest level of regulatory standards and practices for the quality, safety and efficacy of medicines and vaccines.

This achievement is a result of recommendations from the second Technical Advisory Group on WHO-Listed Authorities (TAG-WLA) meeting at WHO headquarters, Geneva, Switzerland, on 16–17 April. The expansion of the WLA framework – to 36 WLAs from 34 Member States – is a transformative milestone in the global public health regulatory landscape. This increase will streamline processes and optimize resources to ensure greater and expedited access to quality and safe medical products. | Read more

Strengthening China’s regulatory system

Thirty Good Manufacturing Practices (GMP) inspectors gathered in Beijing, China, from 22 to 26 April, to participate in a workshop to strengthen China’s medical products regulatory system. The GMP workshop, which used a risk-based approach, was led by the RPQ Regulatory Systems Strengthening Team in collaboration with the WHO Western Pacific Regional Office and the WHO country office in China. The event included three days of interactive presentations, exercises and case studies, followed by two days of mock inspections at four vaccine manufacturing facilities. The workshop is part of RPQ’s ongoing support to the Chinese National Medical Products Administration (NMPA). This support focuses on regulatory inspection, covering topics such as GMP requirements and quality risk management principles for medicines and vaccines.

Collaborative Good Manufacturing Practices audit in Bangladesh

The RPQ Regulatory Systems Strengthening (RSS) Team is continuing to benchmark regulatory systems across Member States. From 22 to 25 April, a Good Manufacturing Practices (GMP) inspection conducted by the Directorate General of Drug Administration (DGDA) in Bangladesh was observed. During the closing meeting, the DGDA presented a detailed report, and the RSS Team shared their findings from the visit. The recommendations were warmly received by the DGDA, and discussions concluded with a focus on the next steps for strengthening the vaccines regulatory system and re-benchmarking the DGDA.

Advanced Good Manufacturing Practices workshop in India

From 6 to 10 May, 30 inspectors from Indian regulatory authorities gathered in Hyderabad, India, to attend an advanced workshop on Good Manufacturing Practices (GMP) regulatory inspection using a risk-based approach. Key recommendations include applying risk-based GMP inspections and extending module durations with more practical examples to enhance learning. The workshop, held by the RPQ Regulatory Systems Strengthening Team in collaboration with the WHO country office in India and the WHO regional office in Southeast Asia, was part of RPQ’s support for strengthening India’s medical product regulatory system.

The first Francophone country in Africa, Senegal, formally benchmarked

From 29 April to 3 May, an international team of WHO assessors, led by the RPQ Regulatory Systems Strengthening Team, conducted the formal benchmarking of the first African Francophone regulatory authority, Senegal’s National Regulatory Authority, the Agence Sénégalaise de Réglementation Pharmaceutique (ARP). Since early 2023, the ARP has made significant progress in implementing its Institutional Development Plan. An updated roadmap towards achieving Maturity Level 3 has been established following this visit. The next step includes finalizing the benchmarking and benchmarking of lot release function for vaccines.

Audit concluded Chinese institute qualified to test WHO prequalified vaccines

An audit of the Institute of Biological Products Control (IBPC) at the National Institutes for Food and Drug Control (NIFDC) in Beijing, China, was conducted on 8–11 April, examining facility inspections, witness testing and documentation reviews to assess their technical competence in performing potency tests for various vaccines, including human papillomavirus, hepatitis A, seasonal influenza, Japanese encephalitis, oral polio bivalent types 1 and 3, inactivated Sabin polio, varicella, meningococcal polysaccharide and pneumococcal conjugate. The audit concluded that the NIFDC is qualified to test WHO prequalified vaccines, contributing to ensuring access to effective quality vaccines.

New experts join two advisory committee meetings

The WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) and WHO Global Advisory Committee on Vaccine Safety (GACVS) typically meet twice a year – separately in May and then jointly in November. Following an open call for experts in December 2023, six new ACSoMP members and nine new GACVS members joined the meetings for the first time.

The 20th meeting of the WHO ACSoMP was held virtually on 13–14 May. The committee reviewed COVID-19 therapeutics surveillance data, topiramate fetal spectrum disorder and valproate’s transgenerational effects. The recommendations will be published in the WHO Pharmaceuticals Newsletter.

The 47th meeting of the WHO GACVS was held virtually on 15–17 May and discussed COVID-19 vaccine safety, hepatitis E, respiratory syncytial virus (RSV) maternal vaccines and dengue vaccines. The recommendations will be published in the WHO Weekly Epidemiological Record.

Workshop on newly prequalified R21 malaria vaccine

The RPQ teams and the Vaccine Preventable Diseases Team in the WHO Regional Office for Africa organized a workshop on the R21 malaria vaccine on 13–15 May. The workshop was attended by national regulatory authorities (NRAs) from 25 countries in the region.

The RPQ Pharmacovigilance Team (RPQ PVG) led hands-on training to enhance the technical capacity of NRA assessors reviewing the Risk Management Plan as part of the registration dossier for new vaccines.

The RPQ Vaccines Prequalification Team (PQ VAX) led a joint review of the R21 malaria vaccine, manufactured by Serum Institute of India, to assist countries deciding whether to authorize the R21 malaria vaccine. PQ VAX presented the evaluations of the non-clinical, clinical and quality assessments, with a special focus on programmatic suitability for prequalification.

The meeting concluded with an agreement on timelines for post-review steps to authorize the R21 malaria vaccine using a reliance mechanism.

New tools and resources

Six local production case studies

Six country case studies – on the local production ecosystems for pharmaceuticals, vaccines and biologicals in Bangladesh, Kenya, Nigeria, Pakistan, Senegal and Tunisia – have been published. These studies provide insights for Member States and relevant stakeholders into the challenges, opportunities and recommendations for strengthening local manufacturing capabilities to achieve quality and sustainability. This aligns with resolution WHA74.6 to improve access to essential medical products through localized production. Read more

New addition to the Vaccine Safety Net

In May, the Safety Platform for Emergency Vaccines (SPEAC) website joined the Vaccine Safety Net (VSN), a global network of websites committed to offering reliable information on vaccine safety. SPEAC, a project of the Coalition for Epidemic Preparedness Innovations (CEPI) and Brighton Collaboration, provides tools, resources and expertise to aid the vaccine development process to improve safety and strengthen confidence in vaccines.

Advancement of post-market data requirements and guidance for monitoring and surveillance of insecticide-treated nets

In December 2023, the RPQ Prequalification Vector Control Products Assessment Team published the guideline for the prequalification of insecticide-treated nets (ITNs). The guideline, now being implemented, requires reassessment of all prequalified ITNs to ensure a consistent pre-market evidence-based evaluation.

Further efforts are underway to enhance post-prequalification data requirements, surveillance and monitoring of ITNs. An updated long-term community studies protocol, which addresses post-prequalification requirements, is set to be published later this year. This protocol characterizes ITNs’ performance under routine use in various contexts, providing opportunities to explore acceptability and access issues as part of product assessment. Additionally, guidance is being developed to support Member States and partners in post-market monitoring, aiming to inform technical questions about ITNs use and optimize data collection. The new guideline strengthens data requirements for ITNs, establishing modern quality standards to ensure at-risk communities have access to innovative, safe and effective products suited to their settings. Read more

Prequalification: latest updates

Stay up to date with the latest prequalification news – from public assessment reports to prequalification lists and sector events – at WHO’s Prequalification of Medical Products page.

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