Public Alert No. 15/2023 – Alert on the Recall of Ivorian Made Skin Lightening Beauty Lotion
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of Caro White Skin Lightening Beauty Lotion by the European Union (EU) Rapid Alert System for Dangerous Non-Food Products (RAPEX). The product does not comply with the Cosmetic Products Regulation as it is said to contain high […]
Public Alert No. 014/2024 -Alert on Recall of Sibutramine Containing Products in Asia
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of some sibutramine-containing products by three regulatory bodies in Asia due to the increased risk of cardiovascular diseases and stroke in users. Sibutramine is an appetite suppressant previously authorized for the treatment of obesity but has been […]
High Cost Of Medicines: Federal Government Assures Nigerians Of Determination To Make Drugs Affordable
The Director General, National Agency for Food and Drug Administration and Control NAFDAC, Prof. Mojisola Adeyeye has assured Nigerians that the current high cost of medicines in the country will become a thing of the past as the Agency in partnership with pharmaceutical industry working hard to bring down the cost of drugs. Speaking in […]
Notice on New Window for Dossier Submissions
This is to inform all stakeholders that the window for submission of new product dossiers will open on 29th April 2024. This submission will be on the NAFDAC Dossier Management System (DMS) Version 2. All applicants who intend to submit dossiers during this window should note the following. New applicants will need to create their […]
Sources of API’s and Excipients
QUALITY OF ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) USED IN THE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCTS (FPPs) FOR THE NIGERIAN MARKET The quality of Active Pharmaceutical Ingredients (APIs) used in Finished Pharmaceutical Products (FPPs) manufacturing directly impacts the safety, efficacy, quality, regulatory compliance, consistency, supply chain, reputation, and cost-effectiveness of pharmaceutical products. Pharmaceutical companies and manufacturers must […]
Introduction of “Pre-Submission Meetings” for Submission of CTD Dossiers for Locally Manufactured Pharmaceutical Products.
The management of NAFDAC has noticed with dismay the high number of dossier applications that do not meet minimal requirements for submission of CTD dossiers. As part of its continuous improvement efforts and strengthening of its regulatory systems, NAFDAC is introducing a ‘pre-submission meeting’ applicable only to local pharmaceutical manufacturers to enhance the quality of […]
Press Release on the Guardian Online Publication “Nestle Adds Sugar to Infant Milk Sold in Poorer Countries”: NAFDAC’s Response
The attention of the Management of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to The Guardian online publication of 17 April 2024 being circulated widely to the general public via social media stating that “Nestle, the world’s largest consumer goods company, adds sugar and honey to infant milk […]
Directive Inclusion of Bioequivalent Data in Dossiers for Product Registration
Dear Stakeholders and international partners, January 2025 Mandatory Inclusion of Bioequivalence Data in Dossier Submissions for Drug Products that do not Qualify for Biowaivers It has been discussed and made public at different meetings of manufacturers that the inclusion of Bioequivalence data in Dossier submissions will be mandatory from January 2025. Multisource pharmaceutical products (generic […]
Public Alert No. 013/2024 -Alert on Recall of Benylin Paediatrics Syrup in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of one lot of Benylin PaediatricsSyrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product. Laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and […]
Public Alert No. 012/2024 – Alert on the Ban on the Sale of Dex Luxury Bar Soap due to Butyphenyl Methylpropional (BMHCA) content
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the ban on the sale of Dex Luxury Bar Soap (No 6 mystic flower) by the European Union (EU). The product does not comply with the Cosmetic Products Regulation as it is said to contain Butyphenyl Methylpropional (BMHCA) which is prohibited […]
