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Happy New Year! Welcome to the January 2023 edition of this newsletter, where we bring you the latest news, events and achievements from our Regulation and Prequalification Department as we strive to improve access to safe, effective and quality-assured medicines around the world.
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Republic of Korea becomes the first country to achieve highest level in WHO medicines and vaccines regulation
WHO announced that the Republic of Korea’s medicines and vaccines regulatory system, represented by the Ministry of Food and Drug Safety, has achieved maturity level four. This means it has an “advanced level of performance with continuous improvement” based on a benchmarking exercise in May 2022 and after working closely with WHO to implement the recommendations made by its team of international regulatory experts. | Read more
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Regional workshop in South Africa on substandard and falsified medical products
The RPQ Department in collaboration with the WHO Regional Office for Africa organized the first workshop on substandard and falsified (SF) medical products in Johannesburg in November 2022. More than 70 participants from 33 countries were trained on the WHO Global Surveillance and Monitoring System to facilitate effective reporting and coordination of substandard and falsified medical products, increase awareness of the dangers of SF medical products, strengthen national post-market surveillance and improve incident management capacity.
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Annual WHO collaborative registration procedure meeting held in Istanbul, Turkiye
The 10th Annual Meeting of the WHO Collaborative Registration Procedure (CRP) took place in Istanbul, Turkiye in December 2022 with the theme “enhancing regulatory reliance through facilitated product introduction: looking to the new normal”. The meeting was attended by 470 participants, both in person and virtually, from more than 55 countries, representing national regulatory authorities including some stringent regulatory authorities, manufacturers, industry associations, partners, and WHO Regional and Country Offices. The meeting aimed to raise awareness of the principles and benefits of using facilitated regulatory pathways, including reliance approaches focusing on the CRP. Participants learned about the assessment processes and available tools to facilitate the implementation of CRP in their own countries and contexts,
including how to adopt and adapt it to their regulatory systems. Participants also discussed their experiences in implementing the CRP across the various product streams in different regulatory environments. This was crucial to help WHO and other participants understand the success stories, existing challenges and strategies to further improve CRP and other facilitated product introduction pathways.
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Launch of prequalification for hepatitis B tests
The eligibility criteria for WHO prequalification assessment have been expanded and now include in vitro diagnostic medical devices which are used for the quantitative detection of hepatitis B DNA. Read the technical specification here. Manufacturers are invited to contact the prequalification team (diagnostics@who.int) to discuss their submission.
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WHO mission assesses the vaccine ecosystem for sustainable local production in UAE
A mission on sustainable and quality local production of vaccines was conducted in the United Arab Emirates (UAE) in November 2022 by the WHO Local Production & Assistance Unit in collaboration with the Eastern Mediterranean Regional Office. Discussions were held with the Department of Health – Abu Dhabi, the Ministry of Health and Prevention of UAE, and other national stakeholders. Throughout the mission, the Government of UAE demonstrated a strong commitment to supporting local production to improve access. Appreciative of the mission team’s findings, UAE expressed their intention to strengthen capacity for sustainable and quality local
production.
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WHO successfully close the third virtual cGMP training marathon for vaccine manufacturing
The third virtual cGMP training marathon was attended by 1100 vaccine and biopharmaceutical manufacturers and regulators from 80 countries. This included four weeks of virtual lectures on advanced WHO cGMP standards for vaccines, followed by a three-day hands-on workshop on real-life case studies. A peer reviewed Q&A booklet, compiling the participants’ questions raised during the eight sessions and the answers from speakers, will be released in early 2023. | Read more
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Appreciation shared for GACVS subcommittee on COVID-19 vaccines
In 2020, several candidate COVID-19 vaccines were developed and access was enhanced through reliance to Emergency Use Listing by national regulatory authorities. A subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) was established and met regularly to monitor and evaluate the safety of novel COVID-19 vaccines. With growing knowledge of the safety profiles of the vaccines, the frequency of the subcommittee meetings was reduced. In December 2022, an appreciation ceremony marked the end of the GACVS subcommittee. COVID-19 vaccines safety will continue to be monitored and discussed twice a year in the routine GACVS meetings and through additional meetings, as needed. | Read more
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Joint UNICEF–UNFPA–WHO Meeting with Manufacturers and Suppliers
The 2022 Joint UNICEF–UNFPA–WHO Meeting with Manufacturers and Suppliers took place in Copenhagen from 28 November to 1 December 2022, with the theme of “Global Health Supplies: Paradigm Shifts in Market Authorization, Procurement and Supply Chain Approaches.” More than 400 participants attended in person, while another 100 joined remotely. The annual meeting provides manufacturers and suppliers with prequalification and regulatory information and updates, enables discussion and feedback, and forges partnerships to support timely access to quality assured health products. | Learn more
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Medical Product Alert N°8/2022: Substandard (contaminated) METHOTREX 50 mg identified in Yemen and Lebanon
Substandard medical products are those that fail to meet either their quality standards or specifications and are “out of specification” [WHO definitions]. Following adverse events in paediatric patients receiving METHOTREXTM 50 mg, the health authorities in both Yemen and Lebanon conducted microbiological testing on the remaining unopened vials of METHOTREXTM 50 mg. Results in both countries were positive for Pseudomonas aeruginosa, indicating contamination of the products. Read more
Medical Product Alert N°1/2023: Substandard (contaminated) liquid dosage medicines in Uzbekistan
This alert refers to two substandard (contaminated) products: AMBRONOL syrup and DOK-1 Max syrup. Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan, found both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants. Read more
WHO has previously published two alerts on other contaminated liquid dosage medicines. Please see Medical Product Alert N°6/2022 and Medical Product Alert N°7/2022.
Publication of the new quality control laboratory list
We are excited to announce the publication of our new quality control laboratory list, linked to our electronic prequalification system (ePQS). The list provides live updates and makes it easier for clients to find and select prequalified quality control laboratories for their testing needs. We hope this new resource will be a valuable tool for our clients, and look forward to receiving feedback on your experiences of using it. Learn more
Prequalification: latest updates
Stay up to date with the latest prequalification news – from public assessment reports and emergency use listings to prequalification lists and sector events – at WHO’s Prequalification of Medical Products page.
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