In an effort to ensure the safety and effectiveness of generic medicines in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has issued a new regulatory directive that mandates Bioavailability and Bioequivalence (BA/BE) studies for all medicinal products submitted for registration.
This directive, released on April 10, 2025, underscores NAFDAC’s commitment to protecting public health and aligning Nigeria’s pharmaceutical regulations with global standards.
What is Bioequivalence?
Bioequivalence is a scientific benchmark that determines whether a generic medicine releases its active ingredient into the bloodstream at a similar rate and extent as the original branded drug. Ensuring bioequivalence means that patients can confidently use generic alternatives with the assurance that they will achieve the same clinical outcomes.
What’s Changing?
Under the new directive:
- BA/BE studies are now mandatory for all generic drugs submitted to NAFDAC.
- A new regulatory framework has been introduced outlining detailed technical guidelines.
- Updated expectations have been set for Contract Research Organisations (CROs) to ensure compliance.
- NAFDAC has published a comprehensive “Note to Industry” to guide pharmaceutical manufacturers and applicants.
NAFDAC is also launching capacity-building programs to help stakeholders understand and adapt to these new requirements.
Why This Matters
This shift is more than regulatory — it’s transformational.
Generic medicines make up a significant portion of the Nigerian pharmaceutical market. However, without verified bioequivalence, the safety, efficacy, and trustworthiness of these medicines remain questionable. NAFDAC’s latest move:
- Builds confidence in generic medicines,
- Helps combat substandard and falsified drugs,
- Positions Nigeria’s regulatory system on par with global best practices,
- And ultimately safeguards patients who rely on these treatments.
What Should Industry Players Do?
Pharmaceutical companies and product registration holders must act swiftly to:
- Assess product portfolios for BA/BE requirements,
- Collaborate with certified CROs,
- And align their regulatory submissions with the new framework.
Timely action is not just about compliance — it’s about staying competitive in an increasingly quality-driven market.
Partner With Us
At IntraHub, we empower pharmaceutical companies and healthcare organizations with the tools and expertise needed to stay ahead of regulatory demands. As NAFDAC enforces stricter guidelines on Bioequivalence (BA/BE) studies, we stand ready to support your team with:
- Pharmacovigilance Services – We help design, implement, and optimize pharmacovigilance systems aligned with both local and global guidelines, ensuring efficient adverse event reporting, compliance, and enhanced patient safety.
- Technology-Driven Solutions – From automated data collection to real-time compliance monitoring, our tech-enabled platforms streamline your pharmacovigilance and regulatory workflows.
- Regulatory Affairs Services – Our specialists guide you through product registration, dossier preparation, trademark registration, and end-to-end regulatory submissions, ensuring smooth market access and approval.
- Training & Capacity Building – Through accredited certification programs, and digital learning modules, we equip your team with the knowledge and skills needed to maintain regulatory excellence.
Whether you're preparing for product registration, updating your safety systems, or adapting to new NAFDAC requirements, IntraHub is your trusted partner for smarter compliance and better outcomes.
📩 Contact us today to learn how we can support your compliance journey and help you bring safe, effective medicines to the Nigerian market.
Email: info@intrahub.africa
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