The National Agency for Food and Drug Administration and Control (NAFDAC) has been officially admitted into the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the agency announced.
This was stated in a press release signed on Friday by Prof. Mojisola Adeyeye, the Director-General of NAFDAC.
Adeyeye described the transition from observer status to full membership in ICH as a historic milestone for the nation.
She stated that the ICH is a select body of leading regulatory authorities and pharmaceutical industry representatives, dedicated to promoting the scientific and technical standards of pharmaceutical development worldwide.
According to her, the ICH safeguards public health by ensuring the availability of safe, effective, and high-quality medicines worldwide.
She noted that NAFDAC’s journey toward full ICH membership began in 2022, when the director-general was advised to apply for observer status.
“Following the submission and approval of its application, NAFDAC was invited to participate in the 2023 ICH meeting in Vancouver, Canada, where the agency delivered a formal presentation as part of the evaluation process.
“NAFDAC was subsequently granted observer status and provided with a set of membership requirements.
“For two years, the agency carried out a series of capacity-building activities on multiple ICH guidelines to demonstrate effective implementation, alongside active participation in Expert Working Groups.
“These steps formed the foundation of the rigorous membership pathway,” she said.
The D-G said the agency met all requirements in April 2025 after a successful ICH M13A bioequivalence workshop in Lagos with manufacturers and virtual engagements with heads of regulatory agencies.
She noted that support received from Northeastern University, Boston, U.S., and the Bill and Melinda Gates Foundation for training programmes significantly contributed to the agency’s attainment of ICH membership status.
Adeyeye said, “This pronouncement was made by the ICH Assembly at the in-person meeting held on Nov.18 and 19 in Singapore.
“The official announcement was later issued through a press release by the ICH on Nov. 26, on its website.
“This achievement places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines.
“For citizens, it means better access to high-quality medical products, while for pharmaceutical manufacturers, it opens the door to improved competitiveness and greater confidence in Nigerian-made products at home and abroad”.
According to her, there are 194 regulatory agencies globally, and Nigeria has now become the 24th member of the select group of 25 national regulatory authorities worldwide.
She said that the authorities were committed to implementing globally harmonised, science-based regulatory standards through ICH membership.
“Being part of the 25 NRAs is significant, and for our country, it represents a major step forward in strengthening the quality, safety, and efficacy of medicines available to our population,” she said.
Adeyeye said the milestone would strengthen the regulation of medicines using global standards, improve access to high-quality medicines, and enhance capacity and technical expertise.
She said other benefits included increased confidence in Nigerian pharmaceutical products, greater attraction for foreign investment, and stronger global partnerships.
She reiterated that the agency would continue to safeguard public health, strengthened by the full support and collaboration of the global ICH community.
