Ref: Second Term Resumption speech (January 4, 2023)
HIGHLIGHTS OF 2023 ACTIVITIES
*Reorganization of Top Management
Continual efforts to strengthen the regulatory and operational efficiency of the Agency, some Directors and other Officers were redeployed.
* Hundreds of Staff Training in all regulatory activities (Few Examples)
- Agency-wide Anti-corruption and Leadership
- Food Safety (Local and International)
- Local Manufacturing of Active Pharmaceutical Ingredients and Excipients
* ZONAL SENSITIZATION CAMPAIGNS IN COLLABORATION WITH HEALTH JOURNALISTS
Bleaching Cream
Drug Hawking and Ripening of Druits with Calcium Carbide
Manufacturing of Active Pharmaceutical Ingrredients and Excipients is critical for drug security. A workshop was organised to build the capacity of regulators, manfacturers and academia, including Part 4 students on October 3-6, 2023.
* APPROVAL OF VACCINES
R21Malaria Vaccine (Full Dossier Approval)
Others: MPox and HPV Vaccines( Approval through Mutual Recognition)
- Emergency Use Authorization: JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non-replicating) By Bavarian Nordic A/S Denmark
- Approval to Use Off Label Gardasil as Single Dose Use in The Routine Immunization for Cervical Cancer
* WHO PREQUALIFICATION
Swipha Product
Yaba Central Drug Control Laboratory
https://www.punchng.com/nafdac-laboratory-gets-who-pre-qualification-approval/
* AUDIT{ ML3 AND QMS}
Annual QMS Audit to ensure that there is continual improvement in our processes and customer service.
The GBT WHO Audit team visited NAFDAC to monitor three regulatory processes under Regulatory Inspection, Market Authorization and Laboratory Testing. We have thus achieved a successful WHO GMP inspection observed audit and have since rolled out our roadmap for the attainment of ML4 by next year.
* UNICEF MEETING WITH PHARMA MANUFACTURERS
To ensure global access of pharmaceutical and other regulated medical products, NAFDAC arranged a meeting of manufacturers with UNICEF in October, 2023. The meeting was very successful and it will open doors in the near future for global access
COMMISSIONING OF NAFDAC STATE OFFICES {OGUN AND NAHCO}
The building of State Offices continues. The new Ogun State Office and NAHCO Export Office were commisioned on May 8, 2023
* RELIANCE
Under-studying/Learning Visit on NAFDAC Traceability {Botswana and Uganda}: NAFDAC has made herself available to capacity building of other sister agencies in Africa for one regulatory function or the other. Botswana and Uganda came to understudy NAFDAC on Traceability.
This is also called Reliance. NAFDAC herself is developing relationships with other regulatory agencies for information sharing and capacity building. Examples of such agencies include US FDA; UK VET; TGA; MHRA, South Korea NRA; Saudi Arabia FDA; South Africa SAHPRA; Egypt EDA
* LAUNCH OF NAFDAC ONLINE TRAINING SCHOOL
Training is ongoing in NAFDAC, local and international. To further enhance capacity of the staff and bring training closer, the Online Training School was launched in October 2023.
The FOOD SAFETY AND APPLIED NUTRITION Directorate anchors the Breast Milk Substitute (BMS) activities on behalf of the Agency and is currently implementing the National BMS Strategic Plan (2021 to 2025); It also serves as the Secretariat of the National Fortification Alliance (NFA), a platform of relevant MDAs, industry, and development partners where issues on the national food fortification programme are discussed. In the period of this report, a courtesy visit to NCS has clarified on issues of HS Codes for single vitamins and minerals that will translate to correct application of tariffs (duty rates) for importers for local premix blending from the previously charged 20% to 5% duty rate; actively participates (along with other relevant MDAs (SON and FCCPC) in the development of a digital monitoring system in the supply chain for vitamin A in large-scale food fortification called the Digital Fortification Quality Traceability Plus – DFQT+) project which has advanced to the stage of deployment.
* EffORTS ON LIFTING THE BAN ON NIGERIA FOOD EXPORTS LIKE BEANS: NAFDAC is assiduously putting in place processes that will result in lifting of ban on food exports such as Beans. The efforts include visiting UK counterparts (UK Veterinary and UK Food safety Agency), working with sister agencies and strengthening our processes, including developing a regulation that servess and legal framework.
BANNING OF PESTICIDES
Veterinary Medicines and Allied Products Directorate has recently commenced the ban and phase out action plan of some pesticide active ingredients. The pesticides that on the banning table are:
- January 1, 2024: Ban of Paraquat,
- 1st November 2024: Chlorpyrifos,
- 1st January 2025: Atrazine
- Ban/phase-out of 12 active ingredients: Carbofuran, Clothianidin, Diquat Dibromide, Diquate Dichloride, Ametryn, Anthraquinone, Carbendazim, Chlorothalonil, Oxadiargyle, Thiacloprid, Methomyl and Thiamethoxam.
- Reclassification of 4 others: Fipronil, Permethrin, Cyfluthrin and Amitraz.
The ICT Unit has commenced the digitization of a structured database of NAFDAC approved human medicines from 2018-To-Date with comprehensive Anatomical Therapeutic Chemical (ATC) Classification based on WHO ATC. The registered drug product Database system is available both on the Web and on Mobile App: The web – https://greenbook.nafdac.gov.ng Mobile App – Can be install from Google App Store (For Android gadget)) and Apple Store (For Apple gadget) the registered drug product database. This would place the needed information on drugs registered by the Agency at the fingertips of the public.
Investigation and Enforcement Directorate has been busy with joint inspection/seizures and destruction exercise of banned or unregistered products. The Directorate destroyed 135 truckloads of fake, counterfeit and spurious seized products and damaged/expired products willingly submitted by stake holders at an estimated street value of about Sixteen Billion Naira (N16,000,000,000.00). It also carried out several raids in The South-East and South-South across Nine (9) states and counterfeit Diageo products worth over thirty-eight million naira (N38,000,000.00) were recovered. (vii) In Lagos state and Abuja, several places were also raided and counterfeited products worth over Two Hundred million Naira (N200,000,000.00) were recovered and seized.
