Press Briefing on Who Pre-Qualification of Afriject 0.5ml Autodisable Syringes Manufactured by Afrimedical Manufacturing & Supplies Ltd. Ibafo, Ogun State.
PROTOCOLS The National Agency for Food and Drug Administration and Control (NAFDAC) is pleased to announce that Afrimedical Manufacturing and Supplies Ltd, Ogun State has achieved WHO Prequalification of a medical device 0.5 ml auto disable syringe after an arduous process, guided by NAFDAC and heavy investment that was made by Afrimedical to achieve this […]
Implementation of ICH E6(R3) and ICH M13a Guidelines
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 […]
International Council for Harmonization (ICH) E6(R3) Good Clinical Practice Training
Executive Summary for International Council for Harmonization (ICH) E6(R3) Good Clinical Practice Training Overview:The National Agency for Food and Drug Administration and Control (NAFDAC) in collaboration with the International Council for Harmonization (ICH), organized an ICH E6(R3) training, which held from April 7 to 9, 2025 at the Marriott hotel, Ikeja, Lagos, Nigeria. This was […]
Public Alert No. 13/2025 – Alert on the Circulation of Counterfeit Accu-Chek Instant Test Strips in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public of the circulation of counterfeit Accu-Chek instant Test Strips. The product was discovered in Jos, and investigations revealed that it originally expired in October 2024 but has been revalidated with a new expiration date of December 2025. A genuine Accu-Chek […]
Public Alert No. 12/2025 – Recall of Batches of Regpara Tablets 25mg due to the presence of impurity
The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public of the recall of some batches of Regpara tablets 25mg by DKSH Hong Kong Limited as a precautionary measure due to impurities in the product. The manufacturer reports that the product contains an impurity, N-nitroso-cinacalcet, which exceeds the acceptable daily […]
Public Alert No. 11/2025 – Recall of Various Products by Sun Pharma, Glenmark, and Zydus Pharmaceuticals Over Manufacturing Issues
The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public of the recall of various products by three drug manufacturing companies in the United States. According to recent information by the U.S. Food and Drug Administration (FDA), leading pharmaceutical firms in India, Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus, are recalling multiple drug products […]
Public Alert No. 010/2025 – Alert on the Sale of a Fake Product Named Wonder Calcium by Health and Hygiene
The National Agency for Food and Drug Administration and Control (NAFDAC) is informing healthcare providers and the public about a report of the sale of a falsified product- Wonder Calcium with fake NAFDAC Registration Number 04-1029. NAFDAC received a complaint from Asad Pharmaceutical Ltd, reporting on the sale of a falsified product (Wonder Calcium). The […]
Public Alert No. 09/2025 – Voluntary Recall of Zovirax IV Infusion by GlaxoSmithKline (GSK) Limited Due to Potential Quality Defects
The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public that GlaxoSmithKline (GSK) Limited has voluntarily recalled one lot of Zovirax IV Infusion 250mg RN3T in Hong Kong due to potential quality defects. The Department of Health (DH) Hong Kong received notification from GSK that its branch in Taiwan is […]
Press Briefing on the Regulatory Framework for Bioequivalence and it’s Relevance to the Nigerian Market
Bioequivalence (BE) is a critical scientific concept that ensures the quality, safety, and efficacy of generic drug products in comparison to their innovator counterparts. It establishes the interchangeability of generic medicines with their branded equivalents, relying on statistically significant clinical outcomes to confirm that generics deliver comparable therapeutic effects. Innovator drugs undergo rigorous phases of […]
Public Alert No. 08/2025 –Alert on the Presence of Counterfeit Artemether/Lumefantrine Tablets Circulating Under Brand Name Aflotin 20/120 in Nigeria
The National Agency for Food and Drug Administration and Control is notifying the public of the presence of one batch of counterfeit Artemether/Lumefantrine tablets circulating under the brand name Aflotin 20/120 in Nigeria. The counterfeit product was discovered and reported to the Agency by the genuine manufacturer, Ajanta Pharma Limited Mumbai, India, According to Ajanta […]
