Reported by: Ijeoma G | Edited by: Gabriel Osa
Nigeria has achieved a significant milestone in its healthcare and pharmaceutical sector with its formal admission into the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This announcement came following the ICH Assembly meeting held in Singapore from November 18 to 19, 2025, marking a historic moment for the National Agency for Food and Drug Administration and Control (NAFDAC) and the nation at large. The membership formally positions Nigeria among the global elite of regulatory authorities that contribute to the harmonisation of pharmaceutical standards, ensuring the production and registration of safe, effective, and high-quality medicines.
At the same assembly, South Africa’s SAHPRA also joined as a full member, while DIGEMAPS, the Dominican Republic, and the Philippine FDA were admitted as observers. This expansion reflects the growing inclusion of emerging market regulators into global regulatory frameworks, allowing countries with developing pharmaceutical sectors to actively participate in shaping standards and best practices. Established 35 years ago, ICH now has 25 members and 41 observers, with a mandate to facilitate collaboration between regulators and the pharmaceutical industry to discuss scientific and technical aspects of medicine development and regulation.
Admission to ICH is not automatic; it requires strict compliance with established criteria. For a regulatory authority to become a member, it must implement at least the three Tier 1 ICH Guidelines: Q1 Stability Testing Guidelines, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice Guideline. Authorities must also demonstrate consistent participation in ICH biannual meetings and present a comprehensive plan to implement all ICH Guidelines within their national regulatory frameworks. NAFDAC’s successful fulfilment of these requirements is an endorsement of its growing capacity, adherence to international standards, and dedication to protecting public health.
The significance of this membership for Nigeria’s pharmaceutical landscape cannot be overstated. By joining ICH, NAFDAC gains a seat at the table where global regulatory policies are formulated, allowing it to influence international standards that will, in turn, affect local drug registration, approval processes, and manufacturing practices. This development directly benefits Nigerian pharmaceutical companies, providing them with access to harmonised guidelines that streamline regulatory approval, reduce duplication, and increase the competitiveness of Nigerian-made medicines in the global market.
Historically, Nigeria has made substantial strides in aligning its regulatory frameworks with international norms. NAFDAC has successfully implemented regulatory structures to monitor clinical trials, ensure the quality of active pharmaceutical ingredients, and enforce good manufacturing practices. These efforts have been critical in fostering a safer pharmaceutical environment and reducing the circulation of substandard or counterfeit drugs. Membership in ICH now formalises these achievements and offers an avenue for further capacity building through engagement with global regulatory peers.
Dr. Faisal Shuaib, Director-General of NAFDAC, described the membership as a milestone achievement, noting that it “marks a historic step in integrating Nigeria’s regulatory system into the global pharmaceutical community, ensuring that Nigerian citizens have access to medicines that meet the highest international standards of safety, quality, and efficacy.” He highlighted that the ICH platform would enhance NAFDAC’s ability to monitor drug safety, improve clinical trial oversight, and strengthen collaborations with international regulatory authorities, ultimately improving health outcomes nationwide.
The benefits of ICH membership extend beyond regulatory oversight. Internationally recognised guidelines can attract foreign investment into Nigeria’s pharmaceutical sector by providing assurance that local regulatory processes align with global expectations. Pharmaceutical companies, both domestic and multinational, can now operate in an environment where compliance is predictable, transparent, and in line with international best practices. This predictability is crucial for research and development, the introduction of innovative therapies, and market expansion, thereby stimulating growth in Nigeria’s pharmaceutical industry.
Furthermore, Nigeria’s membership in ICH strengthens the country’s contribution to global public health. By actively participating in guideline development and harmonisation discussions, NAFDAC can help shape policies that address emerging challenges, including the regulation of biologics, biosimilars, and advanced therapeutics. The country can also benefit from knowledge sharing, training programs, and collaborative inspections, which will enhance the technical competence of regulatory personnel and improve the overall efficiency of the drug approval process.
The ICH Assembly in Singapore highlighted the importance of international collaboration in tackling complex scientific and technical issues. Discussions focused on drug stability, good clinical practice, pharmacovigilance, and quality standards for active pharmaceutical ingredients. Nigeria’s participation ensures that its regulatory needs and perspectives are considered in global deliberations, providing opportunities to advocate for solutions that are contextually relevant to African healthcare systems.
Nigeria’s past engagements with international standards, such as the implementation of Good Manufacturing Practice and adherence to clinical trial protocols, have already shown positive results. These frameworks have contributed to improved drug quality, increased confidence in locally manufactured medicines, and better protection for patients. ICH membership will build upon these foundations, providing a structured mechanism for continuous improvement and alignment with evolving international expectations.
However, with membership comes responsibility. Nigeria must consistently participate in ICH activities, contribute to guideline development, and implement harmonised standards within its national framework. This will require investment in regulatory infrastructure, ongoing training of staff, and close monitoring of compliance by pharmaceutical companies. Yet, the long-term benefits are substantial, ranging from enhanced drug safety and efficacy to increased access to international markets and heightened credibility of Nigeria’s pharmaceutical regulatory system.
Stone Reporters’ remark: Nigeria’s inclusion in the ICH is a reflection of decades of deliberate regulatory development and a strong commitment to public health. Just as South Africa leveraged ICH membership to modernise its regulatory processes, NAFDAC is positioned to drive reforms, improve clinical trial oversight, and attract international investment. This development is also likely to accelerate access to high-quality medicines for Nigerians, reduce dependence on imported drugs, and enhance the country’s influence in global pharmaceutical policymaking.
In conclusion, Nigeria’s admission into the ICH marks a transformative era for the country’s pharmaceutical sector. It signals global recognition of NAFDAC’s regulatory maturity, provides a platform for active participation in international discussions, and sets the stage for further reforms to strengthen public health. By joining the ICH, Nigeria not only gains technical and scientific guidance but also affirms its commitment to ensuring that citizens have access to safe, effective, and high-quality medicines, ultimately enhancing national health security and boosting confidence in the domestic pharmaceutical industry.
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