The NAFDAC Public Assessment Report (NAPAR) is a scientific and regulatory document published by the National Agency for Food and Drug Administration and Control (NAFDAC) to provide transparent information on the evaluation and approval of medicinal products granted marketing authorization in Nigeria. NAPAR is developed from the scientific assessment conducted by NAFDAC during the review of a product’s quality, safety, efficacy and, where applicable, bioequivalence data.

The report summarizes the evidence considered during the regulatory assessment process, including product information, labeling, pharmaceutical quality data, benefit-risk evaluation, and the key milestones leading to marketing authorization. It also provides links to approved product information and, where applicable, outlines any regulatory actions taken after authorization.

By making assessment outcomes publicly available, NAPAR promotes transparency, accountability and public confidence in NAFDAC’s regulatory decisions. It serves as a reliable source of information for healthcare professionals, patients, researchers, industry stakeholders and the General public, while supporting NAFDAC’s commitment to international best practices in medicines regulation.

The structure of NAPAR comprises seven sections: product abstract, approved presentations, product information, labelling, scientific discussion, pre-authorization regulatory activities, and post-authorization actions. This comprehensive format enables stakeholders to understand the scientific basis for NAFDAC’s decisions and the regulatory pathway followed before a medicinal product becomes available for use in Nigeria.