The Federal Government of Nigeria, through the Presidential Enabling Business Environment Council (PEBEC), issued an Executive Order (EO1) to facilitate the ease of doing business in Nigeria. In furtherance of the implementation of this Executive Order (EO1), NAFDAC has put in place some strategies to facilitate regulatory processes for our clients.  

In view of the above, the Agency is organizing a one-day stakeholders’ consultative forum on ease of doing business which has been scheduled to hold as follows:

Date:               22nd November, 2017

Venue:             LCCI Conference Exhibition Centre, Alausa, Ikeja, Lagos - Nigeria

Time:               9am prompt

This year, World Antibiotic Awareness Week will be held from 13 to 19 November 2017. The theme: Seek advice from a qualified healthcare professional before taking antibiotics. WHO encourages countries, partners, and the public to join this campaign and help raise awareness of antibiotic resistance

Monday, 18 September 2017 10:15

Singapore Recalls Faulty HIV Test Kits

The National Agency for Food and Drug Administration and Control has been informed that the Singapore's Health Sciences Authority (HSA), on 6th June, drew the attention of individual to the recall of a brand of test kit, SD Bioline HIV Ag/Ab combo kits.

The HSA stated that it was notified by a Singaporean importer, Unison Collaborative, that nine (9) lots of the kits were recalled by the Korea based manufacturer, Standard Diagnostic Inc. due to their reduced sensitivity. According to the manufacturer, when a patient is in the early window period, the lower sensitivity of the affected lots may reduce detection with the possibility of a false negative result for this subset of patients.

The HSA informed that the SD Bioline HIV Ag/Ab Combo Assay test kit may be unable to detect the infection in the blood during the early stages of HIV infection.

Further information shows that five hundred and eighty four (584) of the SD Bioline HIV Ag/Ab combo kits were supplied to 27 healthcare facilities and 26 clinics and one general hospital in Singapore.

The details of the products are as follows:

BRAND NAME:         SD Bioline HIV Ag/Ab combo kits.

MANUFACTURER: Standard diagnostic Inc. South Korea

LOT NUMBER:               All lots from February, 2016 up to May, 2017

Healthcare Provider’s Action.

  • Healthcare providers in possession of these affected products should stop using them and submit them to the nearest NAFDAC office.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC............Safeguarding the Health of the Nation!!!

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the Bureau of Standard Jamaica, on 25th May, 2017 banned the importation of L.A. Lucky brand Sweet Basil seed into the island.      The product is produced by 3 Dolphins wholesale; 4801 Victoria Drive, Vancouver, British Columbia Canada.

The potential contamination was noted after routine testing by the company revealed presence of Salmonella in some lot of 2.1ounce of the product.

Salmonella is an organism which can cause serious and sometimes fatal infection in young children or elderly people, and others with weakened immune system.

Details of Affected Products.

L.A LUCKY SWEET BASIL SEED  20678 201697 60g All units sold from October, 2015 up to May, 25th 2017. 2.1 ounce, clear plastic package

v  All outlets and consumers with these products should immediately stop their sale and use.The affected product should be submitted to the nearest NAFDAC office for appropriate action. Importers are advised not to import affected product.

NAFDAC..........Safeguarding the health of the nation!!!

The Agency have been notified by the U.S. Food and Drug Administration of its restriction of codeine and tramadol medicines use in children younger than 12 years.

Codeine is approved to treat pain and cough, and tramadol is approved to treat pain.

These medicines have been found to be capable of posing serious health risks including slowed or difficult breathing condition and death in children younger than 12 years.

Single ingredient codeine and all tramadol containing products are FDA approved only for use in adults. FDA is also recommending against the use in breastfeeding mothers due to possible harm to their infants.

The U.S. FDA is also requiring several changes to labels of all prescription medicines containing codeine and tramadol indicating the following;

  • Codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
  • Tramadol should not be used in children younger than 18 years to treat pain after surgery to remove the tonsil and/or adenoids.
  • Recommend against use of tramadol and codeine in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
  • Codeine and tramadol use in breastfeeding mothers is not recommended due to risk of serious health hazards to the breastfed infants, such as excess sleepiness, difficulty breastfeeding, or serious breathing problem that could result to deaths.

Healthcare Provider Action

  • Recommend over-the-counter (OTC) or other approved prescription medicines for cough and pain management in children younger than 12 years and adolescents younger than 18 years especially those with certain genetic factors, obesity, or obstruction sleep apnea and other breathing problems.
  • Healthcare providers and patients should always lookout for tramadol or codeine on labels of prescription bottles.
  • Watch out for signs of breathing problems, slow or shallow breathing, difficulty or noisy breathing, unusual sleepiness and trouble breastfeeding.
  • Report adverse events relating to use of these medicines to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC.........Safeguarding the Health of the Nation!!!

The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified of the circulation of two confirmed falsified Quinine Sulphate 300mg tablet versions in Cameroon and the Democratic Republic of Congo.  The products have been found to contain zero active pharmaceutical ingredients.

Quinine Sulphate is an anti-malaria drug used for the treatment of Plasmodium falciparum Malaria. These falsified products were first discovered by a local NGO on failing field screening. They were submitted to a WHO pre-qualified Quality Assurance Laboratory and subsequent analysis from the laboratory showed neither of the products contained any of the stated active ingredients.

The details of the falsified products are;

Product 1 Product 2

Product Name: Quinine Sulphate 300mg

Manufacturer: Novadina Pharmaceutical Ltd,  

                            London, United Kingdom

Number of tablets per container: 1000

Batch Number: 10H05

Date of Manufacture:  09/2014

Expiry date: 09/2018

Product Name: Quinine Sulphate 300mg

Manufacturer: CAD Pharm, India

Number of tablets per container: 100

Batch Number: F4387

Date of Manufacture:  12/14

Expiry date: 11/18

NAFDAC implores importers, distributors, retailers and the general public to ensure vigilance and avoid the purchase of the confirmed falsified products.

 All distributors, retailers and members of the public with these falsified products should submit products to the nearest NAFDAC office for distruction.

NAFDAC...........Safeguarding the health of the Nation!!!

Fundamentals of Biostatistics in Evidence-Driven Regulatory Decision Making came up partly as an off-shoot of the National Agency for Food and Drug Administration and Control mentorship with Health Canada; and on the other hand as part of the Director General’s vision for NAFDAC to constantly ensure an Evidence-Driven Regulatory Decision Making.

This Biostatistics workshop came up as one of the series of such planned for the Agency’s 2014 Workplan. Again, in line with the recommendation of the Steering Committee working on the Action Plan of the Health Canada-NAFDAC Regulatory Capacity Mentorship Program; this workshop came up on the 6th and 7th March, 2014 at the NAFDAC’s Central Laboratory Auditorium located at Oshodi, Lagos.

The workshop was well attended by the members of the Steering Committee and other staff of the Agency from various Directorates. More importantly, the Director General, Dr. Paul Botwev Orhii OON; also graced the occasion.

Two renowned Professors of Biostatistics from the University College Hospital and University of Ilorin joined forces with Dr. Samson B. Adebayo, the Director of Planning, Research and Statistics (PR&S) and Dr Monica H. Eimunjeze, the Director of Registration and Regulatory (R&R) to deliver high quality Lectures. The workshop took the participants through both classroom lectures and hands-on practical sessions on the use of a Statistical Package for Social Scientists (SPSS) to analyse related datasets from the Agency.

The Director General in his remark, welcomed and appreciated the Director (R&R) and Director (PR&S) for coming up with such a wonderful workshop and further stated that such workshop is long overdue for the status of the Agency. He also appreciated all the facilitators and the staff that attended the workshop.

The Director of R&R, Dr Monica H. Eimunjeze appreciated all staff that attended the workshop and advised them to make good use of the opportunity to enhance their performance and better their output in their respective Directorates.

Dr Samson B. Adebayo, the Director of Planning, Research and Statistics who anchored the workshop encouraged all the participants to put into use; the skills that will be acquired at the workshop. In the opening session, he emphasised how important roles of Biostatistics are in ensuring Evidence-Driven Regulatory Decision Making.

Event picture Gallery:

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The over 193 Member-Nations of the World Health Organisation's newly created Mechanism for the international fight against spurious, substandard, and counterfeit medicines have congratulated Nigeria for the selection of the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Dr. Paul Orhii as the first substantive Chair of the Member State Mechanism (MSM).

Against the backdrop of the global leadership of the National Agency for Food and Drug Administration and Control

(NAFDAC) in the fight against counterfeit drugs, Nigeria has been appointed Chair of the International Steering Committee of the new Member State Mechanism (MSM) for  combating Substandard, Spurious, Falsely-Labeled, Falsified and Counterfeit (SSFFC) medical products.

 Will Ross of BBC’s article online titled “Nigerian texters to take on the drug counterfeiters” caught my attention and I was compelled to quickly respond to save readers from the misinformation, falsehood and junk dished out by the Reporter. Ross’ write-up was supposedly based on interviews conducted with some stakeholders within



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