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Welcome to the March 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.
Recent highlights
High-level WHO mission to Jordan on strengthening the national regulatory system
In response to the Jordanian Government’s request to strengthen its regulatory system for medical products, the WHO Assistant Director-General for Medicines and Health Products Division led a high-level mission in Jordan from 14 to 15 February 2023 along with senior staff of the Department of Regulation and Prequalification, the WHO Eastern Mediterranean Regional Office and the WHO Country Office. The WHO team met with the Deputy Prime Minister, the Minister of Health, and the Director-General of the Jordanian Food and Drug Administration (JFDA) for a briefing on the objectives of the mission to support advancing JFDA to achieve Maturity Level 3 (ML3) according to the WHO Global Benchmarking Tool. The importance of political commitment to address regulatory gaps and to enhance local production of quality-assured medical products in alignment with Jordan’s Economic Modernization Vision for the pharmaceutical sector was highlighted. There was a dedicated meeting with the JFDA to review the implementation status of the institutional development plan following WHO-supported self-benchmarking in 2021 and 2022 and to agree on the next steps for formal assessment. A stakeholders’ meeting on day two focused on the role of stakeholders in facilitating the roadmap to ML3, WHO initiative and approaches for local production of pharmaceutical products which meet WHO prequalification requirements and international regulatory standards.
Global regulatory workshop to share perspectives on COVID-19 vaccines strain update
(Photo: Part of the coordination team of the workshop, which was joined by nearly 200 participants)
Given the continuous and substantial evolution of SARS-CoV-2 since the virus emerged, WHO and regulatory authorities have advised that COVID-19 vaccines be updated to broaden immune responses to SARS-CoV-2 variants. Building on the exceptional collaboration established during the COVID-19 pandemic between the International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO, both parties co-organized a virtual workshop on 26–27 February to share perspectives around the process, timing and regulatory requirements of COVID-19 vaccine antigen update. Nearly 200 participants joined the workshop, including representatives from regulatory authorities from around the world, industries, WHO departments of Epidemic & Pandemic Preparedness and Prevention, Regulation and Prequalification and Immunization, Vaccines and Biologicals, WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), WHO Technical Advisory Group on SARS-CoV-2 Virus Evolution (TAG-VE), and Strategic Advisory Group of Experts on Immunization (SAGE). ICMRA and WHO agreed to continue their collaborative dialogue with an aim to facilitate a structured and aligned global process for COVID-19 vaccine antigen composition recommendations and regulatory approval of vaccines with an updated composition ensuring the timely availability of updated vaccines.
Creating aligned processes for the development of recommendations for Prequalification and Emergency Use Listing
To ensure access to quality-assured, safe and effective medical products, WHO develops recommendations on the use of important health products followed by conducting assessment of prequalification (PQ) or Emergency Use Listing (EUL) of selected products. During the COVID-19 pandemic, WHO expedited the recommendation review and PQ of COVID-19 therapeutics using a parallel process, issuing PQ and EUL decisions right after the publication of recommendations of therapeutics for use.
WHO is now developing similar synchronized, parallel but otherwise entirely independent PQ or EUL processes for medicines, biotherapeutics, vaccines, in vitro diagnostics, vector control products and medical devices with a new or amended recommendation on their use. While the integrity of these processes will be maintained and continue to respect the confidentiality of manufacturers’ information, the aligned processes aim to significantly shorten the time to access innovative health products in low- and low middle-income countries.
Benchmarking of ethics committees in Gambia
In collaboration with the WHO Country Office in Gambia, the WHO Regulatory System Strengthening Team and the WHO Global Health Ethics Unit organized a workshop in Banjul, Gambia, on 14–15 February. The workshop aimed to benchmark the ethics oversight of health-related research involving human participants. It was attended by 30 representatives from research ethics committees, major research institutions, the Gambian regulatory authority, directorates of health services and government bodies such as the Ministry of Health and Ministry of Higher Education, Research, Science and Technology. Recommendations were made to strengthen research ethics oversight in Gambia. These recommendations need coordinated efforts from stakeholders, including government agencies and research institutions, as well as support from international organizations like WHO.
Finalization of the formal benchmarking of the Rwanda Food and Drugs Authority
WHO formally assessed the Rwanda Food and Drugs Authority (FDA) from December 2022 to February 2024, followed by the final evaluation in Kigali, Rwanda, on 27–29 February. Led by the WHO Regulatory System Strengthening Team in collaboration with the WHO Regional Office for Africa and the WHO Country Office in Rwanda, this mission identified strengths and areas for improvement in Rwanda’s regulatory system. Substantial progress has been made in implementing the Rwanda FDA’s institutional development plans. The next steps and a roadmap have been established, leveraging WHO’s ongoing support for plan implementation and assistance from the WHO Coalition of Interested Parties Network. The Rwanda FDA remains committed to achieving a robust, integrated regulatory system.
Updates on WHO Collaborative Registration Procedure
The WHO Facilitated Product Introduction Team welcomes new national regulatory authorities who joined the WHO Collaborative Registration Procedure (CRP) in the past six months. The CRP offers three pathways: CRP for prequalified (PQ) medicines or vaccines (PQ CRP), pilot CRP for in vitro diagnostics (PQ CRP IVDs) and those approved by stringent regulatory authorities (SRA CRP). These pathways were initiated in 2013, 2019 and 2015, respectively. Notable additions include Benin and Lesotho in all three pathways, Madagascar and Togo in SRA CRP, and Burkina Faso, Democratic Republic of the Congo, Senegal and Togo in PQ CRP IVDs. Sixty-five national regulatory authorities (NRAs) are currently participating in PQ CRP medicines, 33 NRAs for PQ CRP IVDs, and 59 NRAs and one regional economic community for SRA CRP. Nearly 1200 product registrations are being facilitated. The Facilitated Product Introduction Team encourages non-participating countries to join the CRP and urges participating ones to maximize its benefits. Currently, a CRP pilot for WHO prequalified vector control products is proposed for six countries: Democratic Republic of the Congo, Ghana, Kenya, Nigeria, Rwanda and Tanzania.
List of participating countries: PQ CRP medicines, PQ CRP IVDs and SRA CRP.
For inquiries, contact the Facilitated Product Introduction Team at prequalreg@who.int
Meeting of the WHO Global Surveillance and Monitoring System in South-East Asia and Western Pacific regions
Following successful meetings in Europe and Africa, the attention of the WHO Global Surveillance and Monitoring System (GSMS) shifted to the focal points of regulatory authorities and health ministries in the South-East Asian and Western Pacific regions. The meeting convened in Phnom Penh, Cambodia, on 27–29 February. The goals were to enhance reporting of substandard and falsified medical products via the GSMS portal and to expand upon incident management training provided by WHO’s e-learning on substandard and falsified medical products, accessible on the WHO’s iLearn platform. These regions grappled with incidents involving contaminated liquid medicines, primarily responding to WHO medical product alerts through medication testing and adverse event analysis.
Hepatitis E Vaccine Safety Working Group meeting
In response to the Global Advisory Committee on Vaccine Safety (GACVS) recommendation in November 2023, the WHO Pharmacovigilance Team coordinated a meeting of the Hepatitis E Vaccine Safety Working Group on 29 February. The objective was to scrutinize safety data from two recent studies and other pertinent information regarding the hepatitis E vaccine Hecolin® during pregnancy. The findings from this Working Group session were then presented at the WHO Strategic Advisory Group of Experts on Immunization (SAGE) meeting held on 12 March. High-level recommendations from SAGE are anticipated shortly following the meeting. GACVS will evaluate the Working Group’s assessment outcomes alongside available data to formulate recommendations. Read the highlights from the March 2024 SAGE meeting.
Swissmedic–WHO advanced training on the assessment of inhalation products
On 6–7 March, Swissmedic and WHO organized an advanced training workshop in Addis Ababa, Ethiopia, to enhance assessors’ ability to evaluate inhalation products. The workshop, attended by 31 senior assessors from 23 national regulatory authorities from five Regional Economic Communities, addressed the growing demand to expand the cohort of inhalation product assessors within the national regulatory authorities. This session marked the first in-person training following two virtual events in 2020 and 2021, which trained 50 assessors. Notably, this training initiative exemplifies collaboration between WHO and Swissmedic to strengthen the Regional Economic Communities’ medicine regulatory harmonization initiatives, aligning it with the global objective of enhancing access to safe, effective and quality medicines.
Technical consultation for the Global Spectral Database
A WHO consultation on 5–6 March in Geneva, Switzerland, jointly organized by the Laboratory Networks and Services Team and the Incidents, Substandard and Falsified Medicines Team, brought together experienced global representatives from academia, industry and regulatory agencies with expertise in screening substandard and falsified medicines. Participants engaged in exploring how to establish and endorse optimal methodologies for constructing a global medicinal products spectral library. This library aims to facilitate swift screening of medicinal products using both benchtop and portable devices, ensuring enhanced efficiency in identifying substandard and falsified medical products.
Assessment sessions for in vitro diagnostics
The Prequalification In Vitro Diagnostics (PQ IVD)Team held an assessment session from 22 February to 1 March. The session gathered 14 subject matter experts from 12 different countries across four WHO regions. Assessors reviewed submissions spanning across new PQ dossier submissions, dossier corrective action plans, change requests and Expert Review Panel documentation. As of 2024, assessment sessions have been integrated into the new operational model for assessments of IVDs. The next assessment session for PQ IVDs is planned from 22 to 26 April in Geneva, Switzerland.
New tools and resources
WHO-Listed Authorities frequently asked questions
A new, transparent and evidence-based framework of WHO-Listed Authorities is being set up to identify the reference authorities that meet the relevant indicators and requirements of high-performing regulatory authorities. It is important to bring clarity to the transition from “stringent regulatory authorities” to WHO-Listed Authorities in the context of WHO’s regulatory system strengthening activities. A WHO-Listed Authorities Frequently Asked Questions section is now available on the WHO website. It will be regularly updated as new questions arise or clarifications are needed.
WHO Global Benchmarking Tool for evaluation of national regulatory system of medical products: manual for benchmarking and formulation of institutional development plans
The manual for benchmarking and formulation of institutional development plans is now updated and available from the WHO website. This manual is intended to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development plans to address areas for improvement. Read the WHO Global Benchmarking Tool for evaluation of national regulatory systems manual.
Landscape analysis of pregnancy exposure registries in low- and middle-income countries
Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure or approval. Pregnancy exposure registries are used to monitor the safety of vaccines and drugs. This review demonstrates that several resources presently exist in settings with limited resources, performing active safety surveillance in pregnant populations. Read the landscape analysis of pregnancy exposure registries in LMICs review.
WHO good manufacturing practices compendium and related guidelines webinar
The Norms and Standards for Pharmaceutical Team, in coordination with the Prequalification Inspection Team, hosted a webinar on 29 January to provide updates on the tenth edition of WHO’s Quality Assurance of Pharmaceuticals Compendium which contains the latest guidelines adopted by the Expert Committee on Specifications for Pharmaceutical Preparations. The webinar highlighted how the WHO good manufacturing practices compendium supports a global regulatory environment for the quality, safety and effectiveness of medicines, and presented the revised WHO good manufacturing practices for Sterile Products and the Guidelines on Technology Transfer in Pharmaceutical Manufacturing. Over 400 participants joined the webinar from academia, manufacturers, national regulatory authorities, consulting companies, public-private partnerships and UN agencies.
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.
