By ebosele@hotmail.com
The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has announced a landmark achievement for Nigeria: the country has secured full membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), moving up from its previous Observer status.
The ICH is an exclusive global body made up of leading regulatory authorities and pharmaceutical industry stakeholders dedicated to harmonising the scientific and technical standards that guide pharmaceutical development.
Its work ensures the global availability of safe, high-quality, and effective medicines through coordinated technical guidelines.
A Journey Marked by Rigour and Commitment
NAFDAC began its journey toward ICH membership in late 2022 following advice to apply for Observership status. After submitting its application, the Agency participated in the 2023 ICH meeting in Vancouver, Canada, where it delivered its formal presentation and received Observership along with a detailed set of requirements for full membership.
Over the next two years, the Agency undertook extensive capacity-building programmes, including training on numerous ICH guidelines and active participation in Expert Working Groups—critical steps toward demonstrating readiness for full membership.
In April 2025, NAFDAC fulfilled the key requirements following a successful international workshop on ICH M13A (Bioequivalence), convened in Lagos with participation from Nigerian manufacturers and virtual engagement from regional regulatory heads.
Prof. Adeyeye noted that this achievement was the result of a meticulous, structured plan supported significantly by Northeastern University, Boston, USA, and the Bill & Melinda Gates Foundation.
Global Recognition
The ICH Assembly formally announced NAFDAC’s admission into full membership during its in-person meeting held on 18–19 November 2025 in Singapore. The body later published the news through an official press release on 26 November 2025.
The Nigerian delegation also shared the good news with Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who warmly welcomed the NAFDAC team and celebrated the milestone.
With this development, Nigeria becomes the 24th among a select group of only 25 national regulatory authorities worldwide committed to globally harmonised, science-based regulatory standards through ICH membership—out of 194 regulatory agencies globally.
What This Means for Nigeria
- Regulation Using Global Standards
Full ICH membership empowers NAFDAC to adopt and help shape harmonised global guidelines, resulting in stronger, science-based regulatory decisions and improved public health outcomes. - Faster Access to High-Quality Medicines
Alignment with ICH standards means Nigerians will benefit from quicker access to innovative and life-saving therapies, backed by increased international confidence in the country’s regulatory system. - Enhanced Technical Capacity
Membership grants Nigeria access to cutting-edge scientific knowledge, training, and global collaboration that will strengthen NAFDAC’s technical workforce and institutional capacity. - Boost for Local Manufacturing and Investment
Pharmaceutical manufacturers in Nigeria stand to benefit significantly as international alignment improves product quality, competitiveness, and eligibility for regional and global markets. - Stronger Global Partnerships
Nigeria’s new status positions it as a key regulatory partner in Africa and supports continental goals under the African Medicines Agency (AMA).
Acknowledging the Contributors
Prof. Adeyeye emphasised that the milestone was achieved through the tireless contributions of NAFDAC’s scientists and staff who served actively in ICH Expert Working Groups. Their technical inputs, rigorous reviews, and sustained dedication demonstrated that Nigeria possesses the expertise required of a global regulatory leader.
She also acknowledged the Federal Government’s support, noting that the extension of her tenure under the Renewed Hope Agenda provided stability crucial to seeing the membership process through.
“This shows that Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts, influencing standards that protect billions of people,” she said.
A Commitment to Excellence Moving Forward
As a full ICH member, NAFDAC reaffirmed its commitment to:
consistently implementing ICH guidelines
strengthening Nigeria’s regulatory ecosystem
supporting domestic pharmaceutical innovation and manufacturing
maintaining transparency, integrity, and science-driven decision-making
The Agency pledged to continue safeguarding the health of the nation—now reinforced by global collaboration and harmonised scientific standards.
A Proud Moment for Nigeria
Prof. Adeyeye described the milestone as a proud moment for NAFDAC, for Nigeria, and for Africa, noting that it reflects the country’s deepening commitment to global health standards.
She expressed gratitude to President Bola Ahmed Tinubu, GCFR, the Honourable Minister of Health and Social Welfare, NAFDAC’s international partners, and the Nigerian public for their continued support.
With full ICH membership, Nigeria takes a significant step toward ensuring that its citizens have consistent access to safe, effective, and high-quality medicines—while strengthening the nation’s position as a leader in regulatory science on the global stage.
