Bioequivalence (BE) study is a clinical trial designed to demonstrate that two pharmaceutical products, typically a generic drug and its corresponding reference innovator brand have similar bioavailability and efficacy hence, interchangeable healthcare practices.
Over 90% of drug products used in the country are generics with which access and affordability is created without compromising quality. Presently, NAFDAC undertakes screening and review of dossier submissions using appropriate risk categorization to ensure conformity with global standards for good quality, safety and efficacy requirements.
To further ensure that generic medicines are quality-assured, NAFDAC now requires Bioequivalence study as additional prerequisite for new registration and renewal of drug product licenses to ascertain that generic drugs being provided to the public can confidently be used in healthcare settings with expected clinical outcomes.
In view of this, the implementation of the requirement will be done in phases starting with drug classes such as antimalarials or antibiotics or neglected tropical diseases. The above notwithstanding, local manufacturers are free to undertake Bioequivalence study on any of their products other than the above, especially products for WHO-Pre-qualification. Other drug classes will be phased-in with subsequent additions. Nonetheless, a set of criteria are being developed to build a strong ecosystem for Bioequivalence studies in Nigeria.
For implementation purposes, NAFDAC has issued the following timelines for mandatory submission of Bioequivalence protocol or study report as follows:
- New registration: Submission of full BE study report is January 2026.
- Renewal applications: Submission of BE study protocol not more than 18 months before expiration of the license. For product license with not more than six months validity, the protocol should be submitted 12 months after the due date for renewal.
- Locally manufactured products: Submission of BE study protocol is January 2026.
- Imported products: Submission of full BE study report is January 2026.
Your continued cooperation in strengthening regulatory systems designed to safeguard the health of the public will be appreciated.
Thank you.
Prof Mojisola Christianah Adeyeye, FAS
Director General – NAFDAC
