NAFDAC WORKSHOP ON ICH E6(R3) AND ICH M13A GUIDELINES AND THEIR IMPLEMENTATION
The National Agency for Food and Drug Administration and Control (NAFDAC), in collaboration with the International Council for Harmonization (ICH), successfully conducted a training workshop on the implementation of ICH E6(R3) Good Clinical Practice (GCP) and ICH M13A Bioequivalence for Immediate-Release Oral Dosage Forms from April 7th–11th, 2025.
This workshop brought together regulators across the West African subregion, pharmaceutical industry professionals, and clinical research stakeholders. The training aimed to enhance regional capacity in clinical trial oversight and bioequivalence (BE) assessment—critical areas supporting evidence-based regulatory decisions and approving high-quality, safe, and effective medicines.
Focus and Relevance of the Guidelines
ICH E6(R3) – Good Clinical Practice (GCP):
This revised guideline emphasizes modernized, risk-based approaches to clinical trial design, conduct, oversight, and reporting. It reinforces data integrity, participant safety, and ethical compliance throughout the clinical research lifecycle.
ICH M13A – Bioequivalence for Immediate-Release Oral Dosage Forms:
As the first in a series of M13 guidelines, M13A provides a harmonized framework for designing and evaluating BE studies supporting generic drug product approval. It includes clear statistical, methodological, and regulatory expectations that ensure consistency and transparency in demonstrating therapeutic equivalence.
Opening Address by the Director General
In her keynote remarks, Professor Mojisola Adeyeye, Director General of NAFDAC, highlighted the Agency’s commitment to adopting globally harmonized regulatory practices and strengthening Nigeria’s position as a leading authority in clinical and pharmaceutical regulation in Africa. She emphasized that implementation of ICH E6(R3) and M13A is essential for achieving full ICH membership and for enhancing the credibility of data generated from Nigeria and the region in global regulatory submissions.
Workshop Highlights and Key Topics
- Principles and structure of ICH E6(R3), including ethical considerations, quality management, and sponsor/investigator responsibilities
- Risk-proportionate approaches to trial monitoring and oversight
- Designing BE studies in line with ICH M13A, including subject selection, pharmacokinetic endpoints, and statistical analyses
- Regulatory review and inspection frameworks for GCP and BE studies
- Case studies and interactive sessions
Outcomes and Action Points
- Strengthened capacity of regulators, ethics committee members, and industry stakeholders to implement GCP principles and assess BE studies
- Identification of regulatory and operational gaps in clinical research governance
- Development of action plans to improve inspection readiness, data quality, and harmonized review processes across West African NRAs
- Commitment to integrate ICH E6(R3) and M13A principles into national guidelines, SOPs, and training curricula
Conclusion
The workshop concluded with a strong commitment to institutionalizing ICH E6(R3) and M13A within Nigeria’s regulatory framework. Participants acknowledged the critical role of harmonized clinical trials and BE practices in safeguarding public health, building research credibility, and facilitating access to quality-assured generic medicines. The engagement further reinforces NAFDAC’s commitment to regulatory capacity-building and supports the broader goals of the African Medicines Regulatory Harmonization (AMRH) initiative.
Links
Executive Summary for ICH E6(R3)
Executive Summary for ICH M13A
NAFDAC Document reflecting Implementation of ICH E6(R3)
- NAFDAC Good Clinical Practice (GCP) Guidelines 2025
- Guidelines for Clinical Investigation of Medicinal Products in the Paediatric Population
- Guidelines for Labelling of Investigational Medicinal Products
NAFDAC Document reflecting Implementation of ICH M13A
