{"id":124255,"date":"2025-12-06T11:24:27","date_gmt":"2025-12-06T10:24:27","guid":{"rendered":"https:\/\/pointblanknews.com\/pbn\/?p=124255"},"modified":"2025-12-06T11:24:27","modified_gmt":"2025-12-06T10:24:27","slug":"nigeria-joins-elite-global-regulators-as-nafdac-gains-ich-membership","status":"publish","type":"post","link":"https:\/\/pointblanknews.com\/pbn\/news\/nigeria-joins-elite-global-regulators-as-nafdac-gains-ich-membership\/","title":{"rendered":"Nigeria Joins Elite Global Regulators as NAFDAC Gains ICH Membership"},"content":{"rendered":"<div style=\"text-align: justify;\">By Daniel Adaji<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">The National Agency for Food and Drug Administration and Control (NAFDAC) has been admitted as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">This follows it&#8217;s transition from its former Observer status.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">In a statement on Friday, the Agency described the development as a \u201chistoric milestone in Nigeria\u2019s regulatory space.\u201d<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">The announcement was made by the ICH Assembly during its in-person meeting held on 18\u201319 November 2025 in Singapore, and later confirmed through an official press release issued on 26 November 2025. With this move, Nigeria becomes the 24th member within a select group of 25 national regulatory authorities worldwide implementing globally harmonised, science-based pharmaceutical standards.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">According to NAFDAC, the membership elevates the country into the ranks of global leaders committed to the highest standards of quality, safety, and efficacy of medicines.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">The Agency noted that \u201cfor our citizens, it means better access to high-quality medical products. For our pharmaceutical manufacturers, it opens the door to improved competitiveness and greater confidence in Nigerian-made products at home and abroad.\u201d<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">The journey to full membership began in late 2022 after the Director General was advised to apply for Observership. Upon application and approval, NAFDAC attended the 2023 ICH meeting in Vancouver, Canada, where it delivered a formal presentation as part of the evaluation process. The Agency was then granted Observership and handed a set of requirements it needed to meet.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Over the next two years, the institution undertook extensive capacity-building, including training on several ICH guidelines and active participation in Expert Working Groups. The Agency said these were critical steps in a \u201cmethodical and structured approach\u201d that made the achievement possible. It also acknowledged support from Northeastern University, Boston, USA, and the Bill &amp; Melinda Gates Foundation for various training programmes.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">NAFDAC fulfilled the final requirements in April 2025 following an international workshop on ICH M13A (Bioequivalence), where it brought together manufacturers in Lagos and held virtual engagements with heads of regional regulatory authorities.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">This membership shift carries major implications for Nigeria. The Agency noted that full participation empowers it to shape and implement harmonised technical guidelines that align with global best practices, ultimately enabling better regulatory decisions. It said patients will gain from faster access to innovative therapies as international confidence in Nigeria\u2019s regulatory systems grows.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">The Agency added that the membership \u201cstrengthens NAFDAC\u2019s technical workforce and institutional capacity,\u201d improves the competitiveness of local manufacturers, enhances opportunities for foreign investment, and reinforces Nigeria\u2019s position as a strategic partner within Africa, especially in supporting the African Medicines Agency\u2019s vision.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">The milestone also reflects the sustained leadership of the Director General, Prof. Mojisola Adeyeye, and the work of NAFDAC\u2019s regulatory scientists. The Agency said it \u201cproudly acknowledges the dedicated NAFDAC staff who have served and continue to serve as members of the ICH Expert Working Groups,\u201d adding that their contributions show that Nigerian experts can \u201cstand shoulder-to-shoulder with global experts, influencing standards that protect billions of people.\u201d<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">It also recognised the role of staff who facilitated international trainings and commended the Federal Government for extending the Director General\u2019s tenure under the Renewed Hope Agenda to ensure continuity of reforms.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Looking ahead, the Agency pledged its commitment to fully implementing ICH guidelines, strengthening Nigeria\u2019s regulatory ecosystem, supporting pharmaceutical innovation, and upholding transparency, integrity, and science-based decision-making. It restated its mission of \u201cSafeguarding the Health of the Nation.\u201d<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Describing the achievement as \u201ca proud moment for NAFDAC, for Nigeria under the Renewed Hope Agenda of the President, and for Africa,\u201d the Agency expressed gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, international partners, and Nigerians for their support.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">NAFDAC said it will continue to safeguard public health, now with the added strength and collaboration of the ICH global community.<\/div>\n<!-- AddThis Advanced Settings generic via filter on the_content --><!-- AddThis Share Buttons generic via filter on the_content --><!-- AddThis Related Posts generic via filter on the_content -->","protected":false},"excerpt":{"rendered":"<p>By Daniel Adaji The National Agency for Food and Drug Administration and Control (NAFDAC) has been admitted as a full member of the International Council for Harmonisation of Technical Requirements&hellip;<!-- AddThis Advanced Settings generic via filter on wp_trim_excerpt --><!-- AddThis Share Buttons generic via filter on wp_trim_excerpt --><!-- AddThis Related Posts generic via filter on wp_trim_excerpt --><\/p>\n","protected":false},"author":1,"featured_media":124256,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[5],"tags":[],"class_list":["post-124255","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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