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  • NAFDAC confiscates counterfeit antiseptics products, nabs three suspects in Onitsha

     

    By Carol V. Utulu

    Asaba:  The Taskforce on Counterfeit of the National Agency for Food, Drug Administration and Control (NAFDAC), has confiscated hundreds of counterfeit liquid antiseptics and bleaching agents in a raid in Onitsha, Anambra state.

    Dr. Christiana Esenwah, the Deputy Director, NAFDAC Directorate of Investigation and Enforcement, told the News Agency of Nigeria (NAN) on Thursday in Asaba that officials of the taskforce also nabbed three suspects during the raids.

    “These products you are seeing here are counterfeits. These three suspects were arrested with the products in Ochanja and Relief markets in Onitsha on Dec. 14, 2022.

    “The raid followed a petition from the makers of the original products.

    “The brand owners sent a petition to NAFDAC that their products are being counterfeited in the markets so we moved in and got these three suspects with the products.

    “The exhibits recovered from them include over five cartoons filled with the counterfeit products and the suspects are here with us.

    “The suspects are undergoing interrogation and after that, they will be prosecuted,” she said.

    One of the suspects, who gave his name simply as Emma, said he regretted going into the illicit business.

    He said he was compelled to venture into the business in order to take care of his father who is very sick and bedridden.

    “I knew what I was doing was wrong but I didn’t have an option. I learnt a trade but after my service year, I didn’t have anyone to help me establish.

    “When I returned home, I met my father down with sickness, with no help anywhere. So I approached one of my friends who taught me how to produce these products.

    “I have only been in the business for about three months now. I need help to take care of my father’s medical bills,” Emma said.

    However, the other two suspects told NAFDAC officials that they were not the producers of the product, but only selling them in the market to make ends meet.

    One of them, who gave his name as Okey, aged 26, said he buys the products in the market and in turn, sells them off to buyers to make profit.

    “I don’t produce these products; I only sell to buyers in the market. I have been doing the business for a long time because I make profit from it,” he said. (NAN) (www.nannews.ng) /Flowerbudnews

  • NAFDAC seizes wines, spirits worth N8m from Apogbon market

    NAFDAC seizes wines, spirits worth N8m from Apogbon market

     

    By Augusta Uchediunor

    Lagos:   Enforcement Officers of the National Agency for Food and Drug Administration, and Control (NAFDAC) and its Federal Task Force (FTF) team have raided the popular Apongbon market in Lagos seizing drinks valued at eight million naira (N8,000,000).

    The operation was part of its efforts to eradicate fake, unwholesome, and counterfeit alcoholic and non-alcoholic wines and drinks from circulation.

    Anita Dabor, Head of Unit, NAFDAC, told the News Agency of Nigeria (NAN) in Lagos that many of the offending products were sold by merchants underneath the bridge.

    ?
    National Agency for Food and Drug Administration, and Control (NAFDAC) at Apogbon market, Lagos. Confiscates fake, unwholesome, and counterfeit alcoholic and non-alcoholic wines and drinks from circulation. December 2022,

    “ They were mopped up and include very popular brands of wines and spirits.

    “During the mop-up operation, a transport vehicle containing an array of drinks including JAPATA (a herbal drink that failed laboratory tests) was found hidden in the vehicle.

    “The offending products were confiscated and evacuated.’’

    “Attempts to apprehend the supplier of the Japata in the market proved abortive.

    “The products mopped up from the market are valued at N8,000,000.’’

    “However, the investigation is ongoing,’’ she said.

    According to her, NAFDAC is fully alive to her responsibilities of assuring the safety, wholesomeness, and quality of foods and other regulated products offered for sale to the public.

    Consumers are hereby advised to be vigilant and exercise discretion when making purchases, especially during this festive season, and report suspicious activities to the nearest NAFDAC office across the Federation. (NAN)www.nannews.ng (Flowerbudnews)

     

  • NAFDAC alerts Nigerians on existence of fake COVID-19 test kits

    By Aderogba George

    The National Agency for Food and Drug Administration and Control (NAFDAC) has notified Nigerians about counterfeit Covid-19 Antigen rapid test kits in circulation.

    The notification is contained in a NAFDAC public alert released to newsmen on Sunday in Abuja.

    The counterfeit BTNX Incorporated COVID-19 rapid antigen test kits was communicated to NAFDAC by Health Canada.

    NAFDAC quoted Health Canada as saying that the fake test kits were sold online in 25-pack boxes by a distributor called Healthful Plus who had not the required licence.

    NAFDAC said the packaging of the counterfeit kits resembles the authentic BTNX Inc. products in colour and typeface and uses the BTNX Incorporated.

    It said that the device identifier has “COV-19C25”, but also has several key differences, adding that it was labelled as manufactured by “Health Advance Inc.” instead of BTNX Inc.

    NAFDAC stated that on the packaging Health Advance was identified as the  “Official Canadian Distributor of the counterfeit products.

    It pointed out that the products had a claim of endorsement by government authorities, such as Health Canada.

    “Genuine COVID-19 Antigen test kit helps detect certain proteins in the virus. Rapid antigen tests are designed to tell in a few minutes whether someone is infected or not.

    “It is recommended as a high performing test for individuals with symptoms, high-risk populations and healthcare or casual workers.

    “Counterfeit health products are imitations of authentic products. The safety and effectiveness of these counterfeit test kits have not been assessed.

    “The genuine manufacturer BTNX Inc. has confirmed that the devices were counterfeit,” NAFDAC said.

    The agency advised wholesalers, distributors, pharmacies and consumers to ensure that their products are obtained from authentic and reliable sources.

    It also encouraged healthcare providers to Increase vigilance within the supply chain to avoid importation, distribution, sale or use of the counterfeit COVID-19 rapid antigen test kits.

    It advised healthcare providers to prevent the administration of the product to unsuspecting patients, adding that the products’ authenticity and physical condition should be carefully checked.

    NAFDAC said that anybody in possession of the counterfeit product should immediately discontinue sale or use and submit stock to the nearest agency office.

    Healthcare providers and consumers are encouraged to report suspected counterfeit health products to NAFDAC on 0800-162-3322 or email: sf.alert@nafdac.gov.ng.

    NAFDAC also advised the public to report adverse effects via pharmacovigilance@nafdac.gov.ng, and e-reporting platforms www.nafdac.gov.ng or via the Med- safety application for download.

    NAN

  • Buhari reappoints Adeyeye as NAFDAC D-G

    Buhari reappoints Adeyeye as NAFDAC D-G

     

    President Muhammadu Buhari (GCFR) has reappointed the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Moji Adeyeye.
    A statement issued to the News Agency of Nigeria (NAN) by NAFDAC Director of Public Affairs, Dr Abubakar Jimoh, on Friday in Abuja stated that Adeyeye re-appointment was for a second tenure of five years.
    Jimoh said  that the re-appointment by the president was conveyed by the Secretary to the Government of the Federation, Mr Boss Mustapha.
    He said: “Adeyeye’s tenure renewal took effect from 1st December, 2022.
    “The DG’s reappointment came closely on the heels of her track record of monumental achievements and successes in the last five years especially in the attainment of World Health Organisation (WHO) Maturity Level 3.”
    Abubakar said that Adeyeye who assumed duty on Friday was received by some staffers at the corporate headquarters of the agency in Abuja.
    NAN
  • Breaking: Pres. Buhari Re-appoints Prof Moji Adeyeye as NAFDAC Director-General

    Breaking: Pres. Buhari Re-appoints Prof Moji Adeyeye as NAFDAC Director-General

     

    By Biola Lawal

    Abuja: (Flowerbudnews): President Muhammadu Buhari (GCFR) has reappointed the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Moji Christianah Adeyeye for a second tenure of five years.

    The Secretary to the Government of the Federation, Mr. Boss Mustapha (CFR) conveyed the approval of the President to Prof. Adeyeye whose tenure renewal took effect from 1st December, 2022.

    This was disclosed in a statement by Dr. Abubakar Jimoh, NAFDAC Director of Public Affairs, a copy of which was made available to Flowerbudnews on Friday in Abuja.

    The Director-General’s reappointment came closely on the heels of her track record of monumental achievements and successes in the last five years especially the attainment of World Health Organisation (WHO) Maturity Level 3.

    Prof. Adeyeye who officially assumed duty today (Friday) was received by some staff at the Corporate Headquarters in Abuja. She will be unfolding her plans for the second tenure after the holidays. (Flowerbudnews)

  • Why NAFDAC is expanding directorates–DG

    Why NAFDAC is expanding directorates–DG

    By Aderogba George

    Abuja:  Prof. Mojisola Adeyeye, the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), says the agency will expand its directorates to promote greater and impactful management.

    Adeyeye made this known at a news conference on Wednesday in Abuja while reeling out the agency’s strategic goals for the years 2023-2028.

    The News Agency of Nigeria (NAN) reports that President Muhammadu Buhari on Dec. 30, 2022, reappointed Adeyeye as the director general of the agency for a second term

    Adeyeye said continuation of meaningful deployment of human capital, sustained strong governance and obtaining approval for Hazard and Regulatory Allowances were among her goals.

    The director general also said she would secure approval for Scheme and Condition of Service as well as ensure well trained staff for SAP account software.

    Adeyeye added that she would increase the Internally Generated Revenue (IGR) of the agency.

    The director general further said that she would use additional media outlets to disseminate information on NAFDAC activities.

    “There will be use of Twitter, Facebook, LinkedIn, drama and comedy artistes to convey importance of quality, safe, efficacious and wholesome regulated products as well as make media parley more structured,” she said.

    Adeyeye promised to sustain the transformation agenda she started in 2017 during her second term.

    She said one of the achievements in her first term was maintaining a well disciplined and motivated workforce, adding that she also eliminated substandard and falsified medicines.

    The director general said fighting the menace of unsafe and illicit drugs were part of her priorities, adding that she aligned NAFDAC with international standards on food, drug and water.

    Adeyeye said she met the agency with glaring symptoms of sundry administrative and procedural lapses such as a huge debt of N3.2 billion and dismally low Internally Generated Revenue of N700 million.

    She also said the skewed nominal roll revealed a disregard for the requirements for federal character with a non post-marketing good distribution practice and surveillance.

    Adeyeye commended the president over her reappointment and National Assembly members as well as international agencies for their support.(NAN) (www.nannews.ng) /Flowerbudnews

  • Prof Adeyeye Unfolds 2nd Term Agenda, Vows More Transformative Initiatives For NAFDAC

    Prof Adeyeye Unfolds 2nd Term Agenda, Vows More Transformative Initiatives For NAFDAC

     

    By Biola Lawal

    Abuja:.  The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye has  Unfolded her  second term Agenda, vowing more Transformative Initiatives For NAFDAC.

    In a speech titled – Second term resumption speech, continuation of transformative leadership of NAFDAC, Prof. Adeyeyel expressed appreciation to President Muhammadu Buhari for the opportunity given her to serve as DG NAFDAC.

    FULL SPEECH:

    SECOND TERM RESUMPTION SPEECH JANUARY 4, 2023

    CONTINUATION OF TRANSFORMATIVE LEADERSHIP of NAFDAC
    (An Agency Strictly Guided by International Standards)

    Doing the right things makes a nation great or, simply stated, Righteousness exalts a nation. On the contrary, not doing the right things brings setbacks.

    I would like to thank the President and Commander-in-Chief of the Nigerian Armed Forces, President Muhammadu Buhari (GCFR) for my reappointment for a second term as Director General of NAFDAC. I am immensely grateful for the Presidency and the efforts made to ensure that I got the second term.

    In the process of the renewal of the term, I have discovered senior Nigerians from different parts of the country that love the country with passion and who worked very hard to ensure that the transformative leadership that started in NAFDAC on November 30, 2017, is sustained.

    I am eternally grateful to my living mentor who has believed in me before I joined NAFDAC.

    He visited me in my university in the USA more than 15 years ago and saw what I was doing in building of quality into medicine development and training of students for such purpose could benefit Nigeria.

    I am indeed grateful to the National Assembly, The Leadership of the Federal Ministry of Health, NAFDAC Council, Sister Agencies with which we collaborate and other Stakeholders.

    My first tenure wouldnt have been successful without the dedicated NAFDAC staff who placed the Agency and the country first, above themselves, and worked hard for the international recognition that NAFDAC now enjoys in both food and drug administration, and control.

    I appreciate them very much.

    My appreciation also goes to African Medicines Regulatory Harmonization (AMRH) of African Union Development-Agency-New Partnership for Africa’s Development or AUDA-NEPAD (whose Steering Committee I chaired for almost five years) and WAHO/ECOWAS-MRH for their understanding during the wait for the second term.

    I am also grateful to the Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria that had been in the tunnel with me since 2017, and especially over the last few weeks in ensuring that the industry is strengthened and becomes competitive globally. NAFDAC (as Maturity Level 3 regulatory agency) is now guided by international standards to ensure that the regulated products are of quality, safe and efficacious, thus safeguarding the health of consumers.

    Our activities are global, and our regulated products are traded on an international platform, thus underscoring the need for use of international standards.

    That brings up our international partners who since 2017 have worked very closely with NAFDAC to ensure that the Agency is strengthened and becomes recognized as an international player in the global arena.

    I am very grateful for their support and waiting during the last six weeks before the announcement of my reappointment.

    These partners include AUDA-NEPAD, WHO, World Bank, Global Fund, USAID, UNICEF, FAO, and Codex Alimentarius; IAEA, GAIN, Alive & Thrive, International Coalition of Medicine Regulatory Authorities (ICMRA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and Organisation For The Prohibition Of Chemical Weapons (OPCW).

    LOOKING BACK 2017-2022

    Upon my assumption of duty on November 30, 2017, I listed the following cardinal points as the goals to be achieved:

    Maintaining a well disciplined and motivated workforce
    Working towards eliminating substandard and falsified medicines (SFs), unsafe or illicit drugs, unwholesome foods, chemicals and other products

    Aligning NAFDAC with international standards in food, drugs and other regulated products regulation
    Reconstruction of NAFDAC web presence and streamlining the submission and approval of dossiers for registration of drugs, food, and water.
    Working towards eliminating overlaps among sister agencies, such as FCCPC, SON, NESREA, NAQS and PCN
    Engagement of Micro, Small and Medium Enterprises (MSMEs)
    Providing much needed Transportation and logistics to inspection sites as part of concerted efforts to strengthen our enforcement activities.
    I thank God that all these and much more have been achieved as stated below.

    For these, I wish to thank again His Excellency, President Muhammadu Buhari (GCFR) and his Advisers for the wisdom in appointing me as the Director General of NAFDAC in the first instance.

    You may please recall; I met an Agency with glaring symptoms of sundry administrative and procedural lapses such as shown below.
    A huge debt of 3.2 billion naira,
    Dismally low Internally Generated Revenues (IGR) of 700 million naira and a collection of 7 billion naira as user fees. Furthermore, adherence to Budget was most irregular or absent altogether.
    Essential physical facilities and laboratory infrastructures had fallen into terrible states of disrepair. Indeed, some NAFDAC laboratories were almost non-functional
    No Scheme or Condition of Service, and payment of staff allowances was very irregular.
    The skewness of nominal roll revealed a disregard for the requirements for Federal Character.
    No Post-marketing Good Distribution Practice (GDP) Surveillance

    It is with gratitude to God, and for the immeasurable support of President Muhammadu Buhari that I report that most of these problems were assiduously confronted and solved as listed below.:

    Governance (WHO GLOBAL BENCHMARKING TOOL (GBT) REGULATORY SYSTEM)

    Capitalized on competence-based HUMAN CAPITAL
    3.02 billion naira inherited debt was paid off within my first year in office. The sum of about 180 million naira were discovered to be fictitious
    Better financial management. The IGR have tripled to 2.5 billion naira. User fees have more than doubled to 15 billion naira.
    2019-Date: International Partners funding (Cash and Technical Support) received – amounted to $3,927,186.00. These funds are currently being utilized for specified purposes.
    NAFDAC was reorganized and more directorates created (from 13 to 27) for effective management
    Established a continuous training culture in customer-centric Quality Management System (QMS) for all NAFDAC mandates
    Accreditation on QMS (ISO 8001-2015) in 2019 and yearly re-accreditation since that time
    More motivated staff through trainings and better emoluments
    The better financial management enabled improvement of infrastructures and building of State offices and laboratories:
    Sokoto, Kebbi, Yobe, Ogun, Kwara, Osun and Ebonyi; plus, Ports Inspection Directorate Airport NAHCO Office and Yaba Drug Laboratory are completed or near completion respectively to meet WHO specifications.
    Over 140 New Utility Vehicles were procured for Inspection and other activities.
    Over 5 billion naira worth of laboratory equipment.
    Scheme and Condition of Service were instituted for the first time in the history of the Agency – currently awaiting approval by The Head of Service.
    Lopsidedness in hiring of new staff was remedied FCC Compliance Certificate on File.
    Established palpable and sustained collaborations with sister agencies (e.g., PCN, NHREC, NCDC, NPHCDA, FCCPC, SON, etc.), with some supported with Memorandum of Understanding
    Aligning NAFDAC with international standards in food, drugs and other regulated products regulation
    Re-accreditation (ISO 17025-2017) of four laboratories since 2018, and accreditation and continual re-accreditation (ISO 17025-2017) of Biologics/Vaccines laboratories in 2019
    All the above are part of WHO Requirements for Maturity Level 3 that were met

    Public Communications
    Transparency
    Basis for Global Benchmarking (Information shared with WHO via SharePoint)
    Most information can be obtained from the website
    Open communication with staff and Union
    Digitalization of regulatory processes
    Procurement and Finance/Account/Human Resources becoming more transparent through SAP platform
    Open communication with international partners
    Continuous improvement

     

    Scheduled stakeholders awareness meeting for different sectors (Examples)
    NAFDAC-MAN (Manufacturers Association of Nigeria) Quarterly Interactive Dialogue
    Pharmaceutical Manufacturers Group of MAN engendered better understanding
    Association of Food, Beverage & Tobacco Employers (AFBTE) for control of consumption of alcohol among children
    National Association of Supermarket Operators of Nigeria (NASON) for tariff reduction and other pending issues
    Small and Medium Enterprises Development (SMEDAN) encouraging small businesses in registration facilitation using the online NAPAMS platform
    Association of Table Water Association. Master Bakers Association, Patent & Proprietary Medicine Vendors Association for self-regulation aside from NAFDAC regulation, and for market collaboration
    Chemical Stakeholders proper handling, storage and moving of certain chemicals
    Food Manufacturers Association on hygienic and safe handling of foods in restaurant or other facilities
    Agro-Allied Sectors on Use of Pesticides
    Herbal Medicines Product Committee of Practitioners and Researchers
    Micro Small Medium Size Enterprises (MSMEs)
    TV Media weekly show on NAFDAC and Your Health (NTA&TVC)
    NAFDAC and Your Health (NTA&TVC) Radio weekly program on FRCN in English, Yoruba, Igbo, and Hausa
    Inter-Agency Meetings to Foster Quality of Product-driven Exportation of NAFDAC Regulated Products
    Social Media coverage of NAFDAC Activities (Moved Desk to DGs Office in October 2022 for better management)
    Quarterly Media Parley
    News from the Zones and States

     

     

     

    NAFDAC Regulations
    Gazetted twenty-eight regulations for food, drug, and Cosmetics (Part of WHO GBT ML3 Regulatory System)
    More regulations on Foods, Drugs, Vaccines, and Traceability in the pipeline for gazetting
    National Assembly Member-Sponsored Amendment of NAFDAC CAP N1 and C34 Bill
    Developed Traceability of the Supply Chain Regulation in process for gazetting
    Developed Vaccine Lot Release Regulation in process for gazetting

    Information and Communication Technology (IMPACTED ALL WHO GBT FUNCTIONS)

    Reconstruction of NAFDAC web presence and digitalization of many regulatory activities such as:
    E-Registration using NAFDAC Automated Product Administration and Monitoring System (NAPAMS) -WHO Global Benchmarking Tool (GBT) – MARKET AUTHORIZATION
    Single Portal Window for Ports Inspection, E-Clinical Trial Application WHO GBT Clinical Trials
    Ports Inspection Data Capture and Risk Management System (PIDCARMS). (WHO GBT MARKET CONTROL)
    E-database for registered drug products Green Book
    E-portal for dossier submission and review App to be launched in Q1 2023

    Training of Staff (Continuous and Agency-wide) WHO GBT Regulatory System Function

    Dedicated budget for staff training
    Technical areas such as Common Technical Document Formatting, Good Manufacturing Practices (Food, Chemical and Drugs), Good Clinical Practice, Good Distribution Practice,
    Leadership and Anti-corruption
    Emotional Intelligence
    Knowledge Management

    Substandard and Falsified (SFs), Counterfeit Medicines, Narcotics & Unwholesome Foods through different means and continual regulatory efforts such as listed below. WHO GBT VIGILANCE, (VT) MARKET CONTROL (MC)

    Restoration of NAFDACs presence at the ports was restored in 2018 after absence since 2011
    Tighter pre-shipment testing and control through Clean Report and Inspection Analysis (CRIA) in India & China since 2019
    Instituted Good Distribution Practices Inspection for the first time since the 1993 as part of supply chain monitoring and mitigating SFs
    Good Manufacturing Practices Road Map that involved 165 companies and resulted in risk-based categorization and monitoring of GMP Compliance
    Instituted in 2021 for the first time in the Agency history, Good Distribution Practice Post-Market Inspection
    Inspected over 550 distribution sites to ensure quality of that medical products
    Blacklisting of erring companies
    Public enlightenments
    Provision for on-the-spot detection of SFs using detection devices
    increased enforcement activities.
    Creation of the Traceability (Track and Trace) system that has been successfully used for the distribution and tracking of COVID-19 vaccines during the pandemic.

    Strict testing of Covid-19 vaccines and Issuance of over 120 Lot Release Certificates
    First African Regulatory Agency to develop Guidance on Regulatory Preparedness for Licensing and Accessing COVID-19 Vaccines
    Developed Guidance to Sponsors of Clinical Trials in Nigeria Including COVID-19 Related Trials
    Testing and issuance of over 140 quality/safety-based Lot Release certificates for ALL COVID-19 vaccines used in Nigeria during the pandemic
    Track and Trace monitoring of all COVID-19 vaccines
    Science-driven rejection of a vaccine consignment that did not meet international standards
    Staff training on Testing and Bio-manufacturing
    Strengthening Local Pharmaceutical Industry through regulatory policies or mediation with the government (WHO GBT MARKET CONTROL AND REGULATORY INSPECTION)

    Good Manufacturing Practice (GMP) Inspection Road Map Inspected over 165 companies GMP compliance that resulted in risk-based categorization
    Instituted Five Plus Five Policy
    NAFDAC Ceiling for medicines with large in-country manufacturing capacity
    Partnership of multi-nationals with local manufacturers are being formed based on good manufacturing practices compliance: Examples – GSK-Fidson Healthcare Plc and Sanofi-May & Baker Nigeria Plc
    Choice of Nigeria as a country that can manufacture vaccines facilitated by Director General and enhanced by attainment of ML3

    Herbal Medicine and Medical Devices Regulation

    New Guidance and Guidelines
    New Technical Information Submission Template
    Inaugurated Herbal Medicine Product Committee
    Organized many stakeholders/practitioners/researchers meetings
    Paired and mediated practitioners/researchers collaboration
    Registered more than forty (40) COVID-19 related herbal medicinal products during the pandemic
    Registered the first Nigerian-made medical mask during the pandemic, and was exported/sold in the USA

    International Collaboration and Reliance

    NAFDAC received support from the following international partners – World Bank, World Health Organization (WHO), United States Pharmacopeia (USP), Bill and Melinda Gates Foundation (BMGF), Global Fund (GF), United States Agency for International Development (USAID), United Nations Industrial Development Organization (UNIDO). These various supports contributed to respective global benchmarking functions and attainment of ML3.
    Training on Food Safety: The Agency has been amply supported in various aspects of Food Safety by the Danish Government through the Royal Danish Consulate General in Nigeria
    Support from Organization for Prohibition of Chemical Weapons (OPCW) in Lab Analysis/Validation and Chemical Management
    Partnership with Global Alliance for Improving Nutrition (GAIN)
    Technical support from USP on Vaccines and Biologics in some aspects of laboratory analysis and Lot Release
    Support from Family Health International (FHI) 360-Alive & Thrive for Breastmilk Substitute (BMS) Code Compliance
    Support from FAO on Total Diet Study that focuses on contaminants including mycotoxins in food as eaten and assessing the risks to the consumers.

    TRANSFORMATIONS IN SECTIONS A-J LISTED ABOVE RESULTED IN ATTAINMENT OF WHO MATURITY LEVEL 3. NAFDAC BECAME ONE OF THE 30% OF ALL REGULATORY AGENCIES GLOBALLY TO ATTAIN ML3
    THE ATTAINMENT MADE NIGERIA TO BE RECOGNIZED AS ONE OF THE SIX AFRICAN COUNTRIES THAT CAN MANUFACTURE VACCINES

    Food Safety Assurance

    Stricter regulatory Inspection or regulated foods and bottled water
    Shutting down of many food companies and water companies
    Baseline inspection of food handling facilities eateries/restaurants
    Faster time for approval (90 working days)
    Re-equipment of Food Laboratories for analysis of food components trace nutrients
    Monitoring of micronutrients in specific food items such as Fats/Oils, Sugar, Milk, etc.
    Training of staff in food safety and certification in ISO 22000
    Improvement on National Total Diet Study Activities to reduce contaminants such as mycotoxins or aflatoxins in foods that are consumed daily or slated for exports
    Risk-based regulatory inspection of food industry
    Better attention paid to products under global listing
    Continuous training in various aspects of food safety

    Proactive interaction and delivery of services to Micro, Small and Medium Enterprises (MSMEs) – Herbal Medicines and Cosmetics – WHO GBT Market Authorization (MA) and Market Control (MC)

    Effective management of MSMEs through decentralization of Food Registration to Zones plus FCT and Lagos Offices headed by Directors (six +2 Directors) for effective management
    NAFDAC was Recognized as most-improved MDA by MSME in 2020
    Continuous improvement in surveillance of food, herbal medicines, and cosmetics

    Chemical Safety

    Continuous engagement of stakeholders in the chemical industry
    Strict guidance on Chemical Good Manufacturing and Distribution Practices
    Close collaboration with Office of National Security Adviser on Distribution of Certain Chemicals
    Training of staff

    Establishment of Organization for Prohibition of Chemical Weapons (OPCW) Laboratory

    President Buhari Intervention Fund in 2018/2019 jump-started the OPCW Lab
    Training and Capacity Building of Kaduna and Oshodi Laboratory Staff
    Continuous proficiency Testing for qualification

     

    Veterinary Medicine and Allied Products

    Capacity building of staff
    Awareness and sensitization Programs for Stakeholders
    Banning of Dichlorvos (100 ml)
    Phase-out banning of Paraquat and other unsafe agrochemicals
    Enhancement in GMP Inspection of veterinary medicine and agrochemical facilities
    Post-marketing monitoring of regulated products

    STRATEGIC GOALS FOR 2023-2028

    Governance, Financial Management and Publicity
    Governance
    Continuation of meaningful deployment use of human capital
    Sustain Strong Governance Expansion of Directorates for greater and impactful management
    Obtain approval of Hazard and Regulatory Allowance (To be funded from NAFDAC Generated User Fees)
    Secure approval of Scheme and Condition of Service
    Sustain Strong Financial Management Continuity and Consolidation
    Ensure well-trained staff on SAP Account Software
    Increase IGR and User Fees by 20% from the current levels based on availability of more infrastructure and tools stated
    More accountability
    Publicity
    Use additional media outlets to disseminate noteworthy NAFDACs activities
    Initiated in October 2022 by deploying Social Media Staff to DGs Office
    Use of Twitter, Facebook, Linkedin, etc.
    Use of drama and comedy artists to convey importance of quality, safe, efficacious, and wholesome regulated products
    Make the Media parley more structured

     

    New Initiatives
    Attain WHO ML4 and World Listed Authority (WLA) Status – Attainment will enable:
    Global trade of Nigerian-made pharmaceuticals through collaborative registration with other regulatory agencies
    Local Pharma manufacturers to be more competitive in AFCTA
    Attain Vaccine Lot Release ML4 to position Nigeria strategically for vaccine manufacturing
    Ensures Good Manufacturing Practice of Nigeria Vaccine Company
    Assures quality, safety and efficacy of vaccines manufactured in Nigeria or imported
    Establishes Vaccine Clinical Trial Research and Service Pipeline for the Local Manufacturer
    Create Office of Womens Health Office
    Understudy drug, cosmetics, and food products that affect women, the unborn and the child
    Emphasize misuse or abuse of drug among women and impact on the child
    More focus on maternal and child mortality and morbidity rate

    Newer Initiatives
    Supply Chain Monitoring
    Continual sanitization of the Supply Chain Units to mitigate counterfeits and SFs
    Scale up Track and Trace of Imported and locally Manufactured Pharmaceuticals
    Establish Structured and Active Tracking and Tracing through Solution Providers
    Initiate Track and Trace of Foods
    Continual vigilance to Reduce SFs, Counterfeit Medicines, and Narcotics
    Enhancing Local Manufacturing (including Vaccines) Quality and Trade
    Training on Active Pharmaceutical Ingredients (API) Regulation
    Develop NAFDAC-Industry API Manufacturing Regulation
    Enhance Research and Development Training Platforms with the Pharmaceutical Industry

    Expand Post Marketing Surveillance (PMS)
    Recruit more staff and provide more tools
    Provide capacity building
    Make Enforcement nimbler for sustained response

    Increase collaboration with Academia
    Regulatory science training
    Drug, food, and herbal medicines regulation-oriented research

    Continuous Strengthening Regulatory Activities
    Creative Engagement of Micro, Small and Medium Enterprises (MSMEs)
    More proactive interaction with different sectors of MSMEs at the State Level
    Better Engagement on Exportation of Regulated Products
    Establish evidenced-based facilitation of export of quality NAFDAC regulated products
    Expand the role of the NAFDAC Office of Trade and International Relations
    Investigation and Enforcement and work collaboratively with NDLEA in mitigating substances or drugs of abuse
    Increase vigilance on cosmetic products
    Maintain Food Safety
    Ensure Chemicals and Agrochemicals Safety
    Establish well-structured Pharmacovigilance Inspection
    Continuation of improvement in ICT Functions
    Enhance Digitalization of More Regulatory Processes for better management and transparency
    Improve the website for better navigation

    Continuation of Infrastructural Development
    Build NAFDAC Headquarters in Abuja
    Continuation of Nation-wide Improvement of working environment Adding more Laboratories, Zonal and State Office Infrastructures

     

    CONCLUDING REMARKS:
    To the glory of God Almighty, and through the relentless efforts of a hard-working staff, the Agency has achieved much success under my leadership in the last five years. We look forward to building on these achievements while working even harder to record more achievements and successes in the coming years. Thank you and God bless.(Flowerbudnews)

  • IHRC hails NAFDAC Boss on quality foods, drugs, other consumables

    IHRC hails NAFDAC Boss on quality foods, drugs, other consumables

    By Diana Omueza

    Abuja: NAN/Flowerbudnews:  The Africa Region of the International Human Rights Commission (IHRC) has commended Mrs Moji Adeyeye, Director-General, National Agency for Food and Drugs Administration Control (NAFDAC) for ensuring quality food, drugs and other consumables.

    The IHRC also nominated her for the 2023 IHRC New-Year Honours Award of Africa’s Mother of Pure Food and Drugs.

    Mr Paul Pever-Gom, IHRC Country Director, said this in a statement on Saturday in Abuja.

    He said that the NAFDAC DG had distinguished herself in such diverse fields with scientific writing, scientific research, research administration and education in the sciences and disease research advocacy.

    According to him, the (IHRC) Situation Room in Abuja, on behalf of the IHRC Africa Region HQ in Nairobi, has announced the IHRC Africa 2023 New Year Honours List.

    “The award is bestowed on individuals who had made outstanding contributions to the advocacy and support of distributing basic foods and drugs, in addition to production of all that citizens consumed for healthy living.

    “The parameters involve fields of biomedical and immunologic research, water science research and policy making for a healthy industrial sector.

    “Moji Christianah Adeyeye, has distinguished herself in such diverse fields with scientific writing, scientific research, research administration and education in the sciences, and disease research advocacy,’’ Pever-Gom said.

    He further commended the NAFDAC DG saying that “at every stage of success or win, she looks for an opportunity to give back to society.

    “The DG has ambitious growth plans for the future of NAFDAC, concentrating on further expansion nationally to double the agency’s successes across the operations of NAFDAC.

    “And the DG is further passionate on endeavours geared towards achieving public safety and raised healthcare standards by stoically enforcing the regulations for food and drugs production, supplies and use,’’ he said.

    Pever-Gom said that the IHRC in Nigeria was paying tribute to these great Africans and the only Nigerian on the list.

    He said that celebrating the Africans named in the New-Year Honours list carried broader significance for the IHRC with regards to the promotion of some high values of the organisation on humanity; tolerance; equality; justice and reconciliation.

    All these values, he said, had helped inspired the visions of United Nations.

    Pever-Gom said that consequently, the IHRC would forward the list to the United Nations Headquarters emphasising the importance to salute and celebrate the Africans.

    He said that the awardees were shortlisted through guidelines that identified, rewarded and encouraged change makers opening doors and fighting the way in learning.

     

    According to him, each nomination is reviewed against a set of rigorous criteria.

     

    “These are based on the degree of the nominees’ work as future oriented, innovative, transformative, and sustainable.

     

    “Our meticulous judging process aims to ensure that judging is fair, open, unbiased and aligned with our vision and mission.

    “We believe that by recognising the most innovative minds in a wide range of scientific research areas and roles of justice and international best practices, we will accelerate adoption of the best ideas and practices,’’ he said.

    Pever-Gom said the recognition and award was a ceremonial activity done annually by the Africa Region HQ of IHRC to capture both the dignity and tremendous personal strength of African heroes and icons.

    He said that the awards were made for those excelling in public service and were deserving of being honoured as true human treasures.

    Pever-Gom said that those featured in the 2023 list were Africa’s foremost voices for the welfare of the people, peace and justice, including experts working for international peace and security.

    He said that the 2023 Africa’s Mother of Pure Food and Drugs Award Nominators were typically members of government bodies, nongovernmental organisations, professional associations and individual thought leaders.

     

    He added that the nominators were credible witnesses to the impact of the nominees and the nominees could be either individuals or teams of up to three members.

    According to him, they can be teachers, researchers, academics, policy-makers and education advocates. (NAN)(www.nannews.ng)/Flowerbudnews

     

  • NAFDAC DG Advocates Strong Regulatory System to Boost therapeutic medicines vaccines Devt in low income countries

    NAFDAC DG Advocates Strong Regulatory System to Boost therapeutic medicines vaccines Devt in low income countries

    By Aderogba George

    Prof.  Moji Adeyeye, Director-General,  National Agency for Food and Drug Administration and Control (NAFDAC), has sought  for a regulatory system for effective quality therapeutic medicines and vaccines in low and medium income countries.
    The D-G made the appeal in a statement signed by the agency’s  resident media consultant, Mr Olusayo Akintola on Wednesday in Abuja.
    The D-G made the assertion while speaking at the hybrid University of California San Francisco UCSF)-Stanford Centre of Excellence in Regulatory Science and Innovation, (UCSF-Stanford CERSI) summit in the United States.
     Adeyeye spoke at the summit as the only panelist selected from Africa on the theme: “Building a Global Vision for Product and Drug Development: Challenges and Opportunities”.
    Adeyeye said that only  a strong regulatory system would guarantee and accelerate the development, approval, and access of safe and effective quality therapeutic medicines and vaccines in low, medium income countries of the world.
    She admonished nations on the premise of strengthening regulatory system in compliance with the World Health Assembly Resolution 67.20 of 2014, to build the capacity of member states with the ultimate goal to have access to quality medicines to different low, medium income countries.
    According to her, the World Health Organisation (WHO) supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening RSS programme.
    She explained to the global audience how NAFDAC under her leadership, used the WHO Global Benchmarking Tools to achieve the Maturity Level 3 WHO Certification Status in March 2022 and its significance to Nigeria.
    Using US Food and Drug Agency as reference which was categorised as Maturity Level four, Adeyeye said that ‘’you cannot get Maturity Level three without taking care of all the indicators under Levels one, and two. and indicators in MLone, MLtwo and MLthree.”
    Speaking on ‘’Global Benchmarking Tool and Access to Medicines’’ at the annual global event, she noted that there was no 95 or 99 per cent in terms of WHO Global Benchmarking.
    She disclosed that the GBT essentially facilitated NAFDAC to identify weaknesses and strength in licensing of products, in the manufacturers and distributors compliance, and how effective and how its post marketing surveillance were doing to contain market control in terms of illicit trade.
    She disclosed that NAFDAC was benchmarked on seven functions including licensing establishment which was under the Pharmacy Council of Nigeria (PCN) jurisdiction, adding that both agencies were benchmarked together.
    She said the agency met and satisfied 268 indicators and 860 recommendations, noting that 268 indicators were distributed under Maturity Levels one, two, three, and four and we were able to attain Maturity Level three after meeting all the requirements and were declared in March 2020.
    She, however, noted that attaining Maturity Level four would not be too difficult and that some of the standards or indicators had  already been met.
    She said that NAFDAC was  working round the clock as she had already set out targets for Maturity Level four and that the agency was  working for both in order to ensure that the system was well established and stable and well-functioning as a regulatory agency.
    The NAFDAC boss,  however,  emphasised the importance of reliance for different regulatory agencies in the world, adding that reliance represented a smarter way of regulating medical products through collaboration, shared knowledge, experience, and resources.
    “The reliance is among the different functions such as regulatory inspection, lab testing, clinical trials, market authorization, pharmacovigilance, market control and licensing establishment.
    She explained that there was a lot of reliance within different functions and there had to be a reliance between agencies, adding that agencies had to collaborate, identify weak links and leverage on the experience of others, mentor others.
    She stated that there could not be local manufacturing without a strong regulatory system, adding that NAFDAC was using a lot of tools to ensure that products from Nigeria were more affordable and were of high quality using different GMP inspection.
    She disclosed that the agency had employed detection devices to get rid of infiltrations in the supply chain,  adding that NAFDAC was  now  using traceability Track and Trace GS1 to monitor falsified medicines.
    NAN