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Welcome to the April 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
Second Coalition of Interested Parties Network Support Plan Development meeting
The Coalition of Interested Parties (CIP) Network was established by WHO to promote a unified, strategic and coordinated approach to strengthening national and regional regulatory systems. The CIP Network convened its second Support Plan Development meeting on 12 April. The meeting determined the CIP Network Support Plan for 2024, announced the four new members of the Network – Duke-NUS CoRE, International Society of Pharmacovigilance, United Nations Children’s Fund and United States Agency for International Development – and provided an update on action items identified during the 2nd Annual Global Steering Group meeting in November 2023. The meeting was joined virtually by 59 participants, including representation by 25 of the 29 CIP Network members and four of the six WHO regional offices. Recommendations for future CIP Network coordination activities were agreed in the context of the implementation of the CIP Network Support Plan for 2024. | Learn more about the Coalition of Interested Parties
Working towards a stronger regulatory system in India through good manufacturing practices
In collaboration with the WHO country office in India, the Regulatory Systems Strengthening Team conducted an in-country advanced workshop on good manufacturing practices for regulatory inspection, with a focus on using a risk-based approach to inspection. Held in Pune, India, from 11 to 15 March, the workshop hosted 40 inspectors from the Indian regulatory authorities. The workshop was initiated as part of ongoing WHO support for a stronger Indian medical products regulatory system, particularly in the area of regulatory inspection.
Virtual follow-up of the Drug Regulatory Authority of Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) benchmarking in 2023 identified a series of recommendations to improve the country’s drug regulation. On 18–19 March, the Regulatory Systems Strengthening Team conducted a virtual follow-up with DRAP to review progress on these recommendations and to agree on the next steps.
Continued efforts to review Russian Federation regulatory system
From 25 to 28 March, the Regulatory System Strengthening Team conducted a pre-benchmarking workshop for the National Regulatory Authority (NRA) of the Russian Federation. This workshop, which supported the NRA’s self-benchmarking and prepared them for the upcoming formal WHO benchmarking process, was part of wider WHO efforts to review the Russian regulatory system for vaccines and medicines against the WHO Global Benchmarking Tool and update the NRA’s and affiliated institutions’ institutional development plans to address gaps.
Improving evaluation skills for French-speaking assessors in Southern Africa
The Southern African Development Community (SADC) Medicine Regulatory Harmonization project, in collaboration with the Regulatory Convergence and Networks Team, developed a two-week training programme to improve the evaluation skills of French-speaking assessors in the SADC for product applications in the common technical document format. The training programme, held from 18 to 29 March in Antananarivo, Madagascar, was joined by 20 junior assessors from Comoros, Democratic Republic of the Congo, Madagascar and Seychelles. The programme addressed the specific needs of francophone Member States, providing training in French to ensure a comprehensive understanding of the standardized regional assessment approach. Additionally, it bolstered national capacity and laid the foundation for ongoing capacity-building in French within the region, with WHO support facilitating effective training through expert engagement.
Audit concludes South African laboratory can be used for testing WHO-prequalified vaccines
The Laboratory Network and Services Team and Vaccines Prequalification Team conducted an audit of the National Control Laboratory for Biological Products (NCLBP) in Bloemfontein, South Africa, from 18 to 20 March. The purpose of the audit – which included a site visit, witness testing and document review – was to observe and confirm the technical competence of the NCLBP to perform potency tests of the components of measles, yellow fever, oral polio vaccine and hexavalent, and pneumococcal conjugate prequalified vaccines. The audit concluded that the NCLBP can be used for testing of WHO-prequalified vaccines. This audit also provided an opportunity for training and capacity-building of a representative from the Nigeria Food and Drug Authority.
Workshop advances medical screening technologies
A workshop on diethylene glycol (DEG) and ethylene glycol (EG) screening technologies was held at Jesus College, University of Oxford, United Kingdom, on 9–10 April. Bringing together global medicines regulatory authorities, researchers, subject matter experts and the Incidents and Substandard/Falsified Medical Products Team, it helped foster a shared understanding of screening technologies and their gaps, and facilitated informed decision-making in medicine quality screening. Workshop participants discussed the proliferation of portable screening technologies and their evolving requirements, particularly in detecting contaminants like DEG and EG. Key outcomes included plans for a screening technologies dashboard, a better understanding of current and future DEG/EG detection methods, a target product profile for screening devices and a roadmap for collaborative research organized by the University of Oxford Medicine Quality Research Group.
First nicotine replacement therapies prequalified
The use of tobacco, which contains nicotine, kills over 8 million people each year around the world, and 80% of tobacco users reside in low- and middle-income countries. The first five nicotine replacement therapy (NRT) products were prequalified on 4 April. This adds important products to the WHO Prequalification Team – Medicines prequalified list to address smoking-related disorders – potentially saving lives. The prequalified NRTs work by supplying nicotine in an alternative form for a limited period, reducing cravings and lessening withdrawal symptoms. Quality-assured gum and transdermal patch NRTs have been prequalified to address disorders related to tobacco use, with the ultimate aim of helping people quit tobacco use completely. The five new products added to the WHO-prequalified list are:
- TD001: Nicotine chewing gum, 2 mg – McNeil Sweden AB – Sweden
- TD002: Nicotine chewing gum, 4 mg – McNeil Sweden AB – Sweden
- TD003: Nicotine 10 mg/16 hours transdermal patch – McNeil Sweden AB – Sweden
- TD004: Nicotine 15 mg/16 hours transdermal patch – McNeil Sweden AB – Sweden
- TD005: Nicotine 25 mg/16 hours transdermal patch – McNeil Sweden AB – Sweden
Enhanced reliance in WHO prequalification of in vitro diagnostics
Prequalification procedures allow WHO to inspect manufacturing sites based on a desk review conducted following the terms of the Medical Devices Single Audit Program (MDSAP). Based on the successful integration of MDSAP reports into prequalification (PQ) inspections – and as part of a broader effort to improve reliance and recognition as key regulatory principles for PQ assessments of in vitro diagnostics – WHO has decided to rely on MDSAP reports to perform desk reviews instead of WHO on-site inspections. Documentary evidence of compliance with PQ requirements may be requested by WHO as indicated in the relevant PQ procedures. This measure will come into force from 1 May 2024.
Webinar for manufacturers of blood glucose monitors and HbA1c point-of-care analysers
On 20 March, the Prequalification – In Vitro Diagnostic (PQ IVD) Team hosted a webinar for manufacturers of HbA1c point-of-care analysers and blood glucose monitors. The webinar provided updates on the expanded scope for the prequalification of IVDs, introduced the WHO Global Diabetes Compact initiative, outlined the WHO noncommunicable disease programme’s work on diabetes, explained the prequalification assessment process and presented two new Technical Specifications Series (TSS) documents (TSS-18 Haemoglobin A1c point of care analysers for professional use and TSS-19 In-vitro diagnostic medical devices for monitoring of blood glucose in capillary blood). The webinar, which drew over 50 participants, concluded with a 30-minute question and answer session. The PQ IVD Team are now accepting submissions, and we look forward to continued engagement with manufacturers interested in submitting for WHO prequalification assessment.
A recording of the workshop can be accessed here (password: 9Hu&&68D).
Continued effort as three new vaccines prequalified
WHO is pleased to announce the addition of three vaccines to its list of prequalified vaccines:
- HEXASIIL diphtheria–tetanus–pertussis (whole cell)–hepatitis B–haemophilus influenzae type b–polio (Inactivated). Two presentations are available: one-dose and ten-dose vials. The vaccine is manufactured by the Serum Institute of India Pvt Ltd. The vaccine is ready to use for intramuscular administration. The shelf life is 24 months to be stored at 2–8°C.
- Influvac against seasonal influenza, manufactured by Abbott Biologicals BV in the Netherlands. The vaccines come in one-dose vial for intramuscular administration. The shelf life is 12 months to be stored at 2–8°C.
- Euvichol®-S Tetra (inactivated oral cholera vaccine) manufactured by EuBiologics Co., Ltd. in the Republic of Korea. The vaccine is available in single-dose plastic tubes. The shelf life is 24 months to be stored at 2–8°C.
New tools and resources
Medical product alert N°1/2024: falsified (contaminated) USP/EP propylene glycol
Dow USP/EP propylene glycol is a raw material (excipient) used in pharmaceutical and other manufacturing processes, adhering to the standards of the United States and European Pharmacopoeias (USP/EP) for medicinal use.
Following WHO Medical Product Alert N°8 on substandard (contaminated) syrup and suspension medicines in December 2023, the Drug Regulatory Authority of Pakistan investigated the potential contamination of oral liquid medicines. Suspect drums of propylene glycol were identified, and samples were tested by Pakistan’s Central Drugs Laboratory. The analyses revealed unacceptable levels of ethylene glycol contamination, ranging from 0.76% to 100%. Read more.
Global hepatitis report 2024: action for access in low- and middle-income countries
Released on 9 April, the Global Hepatitis Report 2024 is the first consolidated WHO report on viral hepatitis epidemiology, service coverage and access to health products. Containing data from 187 countries, regional perspectives and actionable steps to expand interventions, the report emphasizes the importance of using lessons from the COVID-19 response. The report highlights the prequalified in vitro diagnostics, medicines and vaccines for hepatitis and encourages countries to use these products to expedite national regulatory approval by applying reliance principles. It also outlines actions to advance a public health approach to help reach the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. Read the report.
Learn more about viral hepatitis: WHO sounds alarm on viral hepatitis infections claiming 3500 lives each day.
Survey reveals similarities and differences across organizations’ bioequivalence assessments
The Bioequivalence Working Group for Generics (BEWGG), within the International Pharmaceutical Regulators Programme, aims to promote regulatory convergence and harmonization by gathering insights about bioequivalence (BE) assessment of generic drugs from member agencies and organizations. The latest survey findings examine similarities and differences in BE study design recommendations for immediate-release solid oral dosage forms among participating members, drawing from respective regulatory guidance and policies. Results reveal a consensus on using single-dose crossover study designs in healthy volunteers, using pivotal studies with a minimum of 12 subjects for validity, and primarily relying on parent drug data for BE assessment. However, there are variations in the finer design details, including fasting/fed conditions and BE acceptance criteria (particularly for narrow therapeutic range drugs), highly variable drugs, and drugs for which the rate of absorption and onset of effect are clinically important. This work by BEWGG aids internal harmonization efforts, including those led by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Read the paper.
Updated contact list for the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
WHO is pleased to announce that the contact list of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (WHO CPP Scheme) has been updated.
The WHO CPP Scheme is an international voluntary agreement that has been in place since the 1960s. Its purpose is to assure WHO Member States participating in the Scheme regarding the quality of pharmaceutical products circulating in their markets.
The list can be viewed here.
Spanish website Andavac joins the Vaccine Safety Net
The Spanish website Andavac became a member of the Vaccine Safety Net in April. Established by WHO in 2003, the Vaccine Safety Net is a global network of websites dedicated to providing reliable information on vaccine safety. Andavac is part of the strategic plan for vaccinations established by the Ministry of Health and Consumer Affairs of Andalusia. Supported by the Andalusian School of Public Health, its primary objectives include training health professionals and providing vaccine-related information to the general population in Andalusia.
WHO pharmaceuticals newsletter – No. 2, 2024
The WHO pharmaceuticals newsletter provides the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world. This edition includes a summary and recommendations from the third joint meeting of the WHO Advisory Committee on Safety of Medicinal Products and the WHO Global Advisory Committee on Vaccine Safety held 13–15 November 2023. Read the newsletter here.
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.
Get involved
Collaborative procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products (QAS/24.951)
You can download the document from the WHO website under “Working documents in public consultation”.
Please provide your comments through the online platform called PleaseReview, which facilitates document review, co-authoring and redaction. You should have received an email from jonessi@who.int to participate in the public consultation of the review of QAS24_951_Vector_Control. This email may have gone into your spam/junk inbox.
You can use this link to provide comments directly in the document in PleaseReview.
To access the platform, please click here. Select the first option, “PleaseReview Admin only”, and select the “Reset password” option to set a new password. Once you enter the review, please use PleaseReview Quick Guide to Reviewing a Word Document.
For any technical queries on the document, please contact Mrs Agnes Kijo, Technical Officer, Facilitated Product Introduction (kijoa@who.int), and copy in Ms Sinéad Jones (jonessi@who.int, nsp@who.int).
Your comments on this document should be submitted by 14 June 2024. Please note that only comments received by this deadline will be considered.
Call for medicinal products to treat neglected tropical diseases
The latest call for expression of interest targeting manufacturers of medicinal products for neglected tropical diseases (NTDs) was issued on 8 April. The call includes arpraziquantel 150 mg and 300 mg (scored) dispersible, preferably orodispersible, tablet (also known as L-praziquantel or R-(-)-praziquantel) for the prevention and treatment of schistosomiasis, and rifampicin 150 mg and 300 mg capsules for the post-exposure prophylaxis of leprosy. The 2022 WHO schistosomiasis guideline recommends annual preventive chemotherapy with praziquantel in endemic regions for all ages from 2 years old, yet lacks paediatric formulations, leaving younger children underserved. Access to child-friendly arpraziquantel formulation via prequalification will extend preventive chemotherapy to all at-risk groups, aligning with the 2021–2030 NTD roadmap. Additionally, single-dose rifampicin is endorsed as effective chemoprophylaxis for leprosy contacts, in-line with WHO 2018 guidelines. Enhanced access to prequalified rifampicin supports broader efforts to eliminate leprosy globally.
Interested manufacturers can consult the 8th expression of interest for NTDs.
Upcoming events
Webinar on WHO Global Model Regulatory Framework for medical devices including in vitro diagnostics
This webinar will support the dissemination of the WHO Global Model Regulatory Framework (GMRF) for medical devices including in vitro diagnostics, focusing on the guiding principles and the attributes of effective and efficient regulation. The GMRF is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place.
The registration link will be shared in due course. For any inquiries regarding the webinar, please contact Agnes Kijo: kijoa@who.int
Virtual PQT/MED training for regulators
The 16th Annual Prequalification Team: Medicines (PQT/MED) Quality Assessment Training will be conducted virtually on 10–13 June. The course will focus on the principal quality aspects of assessment of a generic product dossier (active pharmaceutical ingredients and finished pharmaceutical products) submitted to PQT/MED. Additionally, it will address bioequivalence and biowaiver topics, offering practical solutions to common assessment challenges.
This will be followed on 14 June by the 3rd Annual Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) assessment training. This virtual training will focus on key requirements for assessing BTP and SBP dossiers, emphasizing product analytical characterization and biosimilarity, process development concepts, comparability pre-post process changes and viral safety. The training will also include BTP/SBP-specific clinical and pharmacovigilance requirements. Aimed at regulators from emerging markets, these training courses feature senior assessors from PQT/MED as speakers and mentors. More details, including agendas and application procedures, are available here.
Joint UNICEF–UNFPA–WHO meeting with manufacturers and suppliers, UN City, Copenhagen, Denmark
The annual joint WHO–UNICEF–UNFPA meeting with manufacturers and suppliers is a pivotal platform for engaging with stakeholders involved in the prequalification programme and health product procurement. the week-long event draws approximately 400 participants, including representatives from national regulatory bodies, manufacturers, suppliers, research institutions, development partners and academia. Focusing on medicines, vaccines, diagnostics, and vector control products, it aims to promote equitable, affordable and prompt access to internationally accredited health products via prequalification, procurement and sustainable supply chain management. Previous meetings have increased stakeholder interest in these topics, resulting in over 1500 prequalified products. The upcoming meeting will take place at UN City, Copenhagen, Denmark, on 2–6 December.
For participation details, consult the WHO website.
