Note to Industry on Requirement for Bioequivalence Study
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, […]
Danish Embassy, Danish Veterinary and Food Agency, Partner NAFDAC to Combat Antimicrobial Resistance
The National Agency for Food and Drug Administration and Control NAFDAC in its quest to safeguard the health of the nation, in partnership with the Danish Embassy held a stakeholders workshop on the dangers of Antimicrobial Resistance, AMR. The Director General of NAFDAC, Prof. Mojisola Adeyeye at the two-day workshop to celebrate the 2024 World […]
Opening Remarks by Prof. Mojisola Christianah Adeyeye, at the World Antimicrobial Awareness Week (WAAW) 2024 Titled Educate, Advocate, Act Now
Opening Remark By Prof. Adeyeye C. M Director General NAFDAC Antimicrobial Awareness Week (WAAW): Educate, Advocate, Act Now Lagos, Nigeria 21st November, 2024. PROTOCOL It is my privilege to welcome you to this year’s World Antimicrobial Awareness Week (WAAW) titled; Educate. Advocate. Act Now. This week provides the Agency an opportunity to raise awareness about […]
Building A Strong Bioequivalence Study Ecosystem in Nigeria
The investigation of bioequivalence of drugs involves the comparison of the rate and extent of active ingredient absorption between the generic product and the innovator’s brands. This comparison is usually performed through clinical trials in human subjects or through in vitro studies using simulated biological fluids. The results of these studies provide the basis for […]
Public Alert No. 043/2024 – Alert on the Sale of Counterfeit COMBIART (Artemether + Lumefantrine 20/120mg) Dispersible Tablet in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) is writing to inform the public about the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in the country. The product is manufactured by Strides Arcolab Limited, based in India. This product was discovered in the FCT and Rivers State, during surveillance activities conducted by […]
NAFDAC List of Recognized Standards for Medical Devices
This is to inform the public of the National Agency for Food and Drug Administration and Control (NAFDAC) list of recognized standards for medical devices including in vitro diagnostics. Click to download Was this helpful? Yes No Submit Cancel Thanks for your feedback!
Public Alert No. 042/2024-Alert on Recall of Forty-Five Thousand (45,000) Unit of Ryaltris Nasal Spray Manufactured by Glenmark Pharmaceutical Inc
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of forty five (45,000) units of Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray, manufactured by Glenmark Pharmaceutical Inc. The company recalled the affected lot due to defective delivery system and which is a safety concern. Ryaltris […]
Public Alert No. 041/2024 – Alert on the Recall of Nivea Roll-On Deodorant Due to Safety Concerns by European Union Rapid Alert System for Dangerous Non-Food Products (Rapex) Authorities
The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the recall of Nivea BLACK &WHITE Invisible Roll-on deodorant, 50ml marked 48H Protection in African Climate with batch number: 93529610 by European Union (EU) Rapid Alert System for Dangerous Non-Food Products (RAPEX) in Brussels. The recalled Nivea product is said to […]
Public Alert No. 040/2024 – Alert on the Sale of Unregistered Simbrinza Eye Drop 10mg/ml + 2mg/ml (Brinzolamide+Brimonidine) in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) wishes to inform the public about the sighting of unregistered Simbrinza Eye Drops with batch number VAF36C in Port Harcourt, Nigeria. The Marketing Authorization Holder (MAH) of the registered brand (Norvartis) reportedly sighted the unregistered brand of Simbrinza Eye Drops in Port Harcourt, Rivers […]
Public Alert No. 039/2024 – Alert on the Sale of Unregistered Foula Condom in Circulation in Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the illegal sale and distribution of an unregistered brand of condoms in Nigeria: Foula Condoms. Officials from the Post-Marketing Surveillance (PMS) directorate discovered Foula condoms (packaged in threes) in Abakaliki, Ebonyi State, and Zango, Katsina State. This discovery was […]
