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  5. Address By Director General Of NAFDAC, Prof Moji Christianah On Her 4th Year Anniversary In…

Address By Director General Of NAFDAC, Prof Moji Christianah On Her 4th Year Anniversary In Office On Tuesday, 30th November, 2021 In Abuja



It is a great pleasure for me to welcome you all to this very important and special Press Conference organized by the Agency to commemorate the 4th year anniversary of my assumption of office as Director – General of NAFDAC. It is with a great heart of gratitude that I give glory and adoration to Almighty God for His mercies, benevolence, guidance and preservation.

This Press Conference offers golden opportunity for us to take stock of the flurry of events, regulatory activities, challenges, opportunities and achievements in the last 4 years that took NAFDAC through charting a new course to where the Agency is today. The goal of the last four years is   safeguard public health, strengthen the industry, pursue customer-centric regulatory activities, play pivotal role in the growth of Micro, Small and Medium Enterprises (MSMEs), enthrone top notch Quality Management System (QMS) and strive towards attaining the World Health Organisation (WHO)’s level 3 Global Benchmarking for Top ranking Regulatory Authorities.

This press conference literally represents a self- assessment and sober reflection on where we are coming from, where we are and where we are going in a futuristic sense as a Regulatory Agency. Permit me therefore to take a cursory look at the situation in NAFDAC on 30th November, 2017 when I took over the helms of affairs. Regrettably, I met an Agency whose regulatory activities were at the lowest ebb, staff morale was low, glaring cases of indiscipline and labour union strikes as well as general lack of administrative focus and direction. I knew the regulatory framework was weak and therefore needed systemic overhauling.

I quickly realized that it will take putting in place seven internationally defined building blocks that are based on World Health Organization recommendations in order to strengthen the Agency. For strong regulatory framework, a quality system approach or template must be in place that places premium on the customer. Therefore, we decided to adopt an agency-wide quality management system (ISO 9001) that took the entire staff through training (from February 2018-June 2019) in use of self-auditing, standard operating procedures, proper documentation, transparency, digitalization of her processes, etc.

ISO 9001:2015 Quality Management System Certification: Under my leadership, Quality Management System (QMS) has been entrenched in the Agency with all our processes procedure driven. The Agency was ISO 9001:2015 Certified in June 2019. NAFDAC has been received recertification in 2020 and 2021. This continued recertification is based on continual improvement (self-audit) in regulatory culture to always put the customer first.  

GLOBAL BENCHMARKING: The WHO Benchmarking Programme (ISO 9004) commenced in January 2018 and since then we have imbibed a culture of self – audit as part of WHO-Global Benchmarking requirements and in line with International Best Practices. We have continued to improve our maturity level since the first WHO Audit in June 2019. We have been working towards attaining Maturity Level 3 to enable Nigeria to strengthen our systems and to enable Nigeria to manufacture vaccines. This is also based on continuous self-audit in all or regulatory processes that could improve the image of the Agency and Nigeria.  This year, the WHO officials were in the country to audit our activities and I can report back to you that they were glad about what they saw on ground. Basis for their satisfaction is on the different building blocks that NAFDAC has put in place as stated below:


In January 2018 NAFDAC had 186 recommendations to satisfy. About a month ago, the Agency had fulfilled all the recommendations. What did we do?  

INSTITUTION OF STRONG GOVERNANCE:   Under my leadership, the Agency has been restructured and expanded in structure from thirteen (13) Directorates to eighteen Directorates (including the FCT). The five newly created Directorates are Laboratory Services; 1) Legal, 2) Yaba Central Drug Laboratory, 3) Kaduna Area Laboratory, 4) Agulu Zonal Laboratory and 5) Food Registration and Regulatory Affairs. Other restructuring that has happened include the upgrade of our six (6) Zonal Offices, FCT and Lagos Offices to Directorate status and are all now headed by Directors thereby creating more vacancies and enhancing career progression at the directorate cadre.  

As part of the restructuring, directorate-focused budgeting was instituted

I met a N3.2 billion debt but confronted this big challenge with great resolve to change the negative narrative by working relentlessly with the Finance and Accounts Directorate.  The following changes took place within a year.

  • Bringing financial sanity to the Agency by stepping down all fictitious claims.
  • Introducing budget discipline to all financial activities in NAFDAC.
  • Reducing the Debt Profile of N3.2 billion naira of the Agency to zero as at 20th November, 2018.
  • Introducing cost effective measures thereby steadily increasing the Agency’s cash position in TSA.
  • Put both human and material resources in place that have resulted in boosting the Agency’s internally generated revenue significantly and also reducing recurrent expenditure drastically
  • Payment of N14,246,499.00 Severance Allowance for the first time in the history of the Agency to the staff who retired from NAFDAC between July and September 2018
  • Discovery and recovery of N106,590,298.52 erroneously credited to another MDA in 2015 as a result of deep reconciliation exercise carried out in Final Account unit.
  • Recovery of 533 million naira evaded administrative charges (2014 to 2017) from stakeholders by the Ports Inspection Directorate, of
  • Completion of Management Account for year 2016 up-till date.
  • Putting machinery in place to ensure that all statutory deductions are remitted in due course while contractors and staff claims no longer suffer unnecessary delay.
  • Maintaining all Books of Accounts in compliance with International Public Sector Accounting Standards and Generally Accepted Accounting Principles
  • Demanding regular financial information for guidance in decision-making.

 Staff Motivation, Development and Training: Part of effective governance is having a well-motivated staff body to share the vision of making the Agency strong.

Under my leadership, staff training, and capacity development has been given great priority in the Agency. No fewer than 3,600 staff have been trained and retrained in the last four years. Similarly, Staff are being encouraged to undertake academic programmes to improve their expertise on the job provided it does not interfere with their official assignments. With a transparent and quality-driven work environment that is expected of a regulatory agency, our staff are now well motivated, disciplined and more dedicated.

Prior to 2018, many times when staff are going for inspection, a company will need to send a vehicle which should be an anathema in a regulatory agency. Since 2018, 40 utility vehicles that are critical have been purchased while 73 vehicles are being processed by the Agency. These vehicles are Hilux vans for the state offices for the operation of the agency.

It’s my believe that every state should have at least three vehicles for operation as an essential tool for the agency. Before I assumed office, the newest vehicles in the agency were bought as far back as 2014. Because of the rate of usage, most of them are ramshackle. These are the vehicles that are always on the road. The directors too don’t have vehicles. The contract for the 73 vehicles has been awarded and by December or January the vehicles will be distributed amongst the directors for official use. There has been a tremendous increase in staff welfare. There have been some allowances that were not in existence before. We are pursuing the possibility of creating another salary structure for the staff while we are also pursuing the National Salaries, Wages Commission for the possibility of getting additional allowance that we never enjoyed before. For instance, we are looking at how we can increase our hazard allowance, regulatory allowance, and others like that to make our staff well-motivated and more efficient.

Conducive Environment for Regulatory Activities: Going round many state and zonal offices in the country, I saw a pitiable environment to attend to customers that have negatively impacted staff productivity. Therefore, from our prudent financial management, we budgeted for construction of some Zonal/State Offices. The offices that are under or near completion are Kebbi, Sokoto, Yobe, Kwara, Ogun, Osun and Ebonyi. Plans are underway to construct five additional State Offices in Edo, Delta, Kano. Enugu and Kaduna form the 2021 budget. In addition to these the NAHCO Ports Inspection Office in Ikeja, expansion of Yaba Drug Laboratory and upgrading of the Biologics/Vaccine laboratory are all under construction.  

Revamping of the Information Communication Technology (ICT) Unit: Our Information Communication Technology Unit has tremendously changed and there is significant improvement in communication among staff and between the Agency and the public especially our interested parties. Some of the basic things we have changed are introduction of Zoom videoconferencing between/among our formations in 2018, reconstruction of NAFDAC web site and populating it continually with needed information that is accessible to stakeholders. Online registration was initiated in 2019 while three hundred and fifty (350) computers were acquired with another 400 computers to be delivered soon. Providing IT tools to all our staff will continue. Staff have also been aligned to the use of government backed mail system to improve security in communication. The video conferencing instituted before COVID-19 pandemic enabled all NAFDAC staff to participate in meetings without too much travel, and I must stress, this has reduced travel cost and contributing to reduction in overall expenditure.

Community Engagement and Enlightenment:  One of the key expectations of a regulatory agency is information dissemination to the public to effectively safeguard the health of Nigerians. NAFDAC continues to engage and enlighten the public on NAFDAC’s activities about their health. In the past four (4) years, the Agency has engaged eighteen media partners which include four (4) Television Houses and the FRCN.

Gazetting of NAFDAC Regulations: For our regulations to be regarded as official government documents, NAFDAC needed to update and gazette her regulations. This was achieved in 2021 through NAFDAC’s Governing Council with the approval of the Honorable Minister of Health when twenty-eight (28) regulations were gazette.  The gazette regulations are on our website at



Detection and Elimination Of Substandard and Falsified Medicines (SFs), Unsafe or Illicit Drugs, Unwholesome Foods, Chemicals and Other Regulated Products

This is the crux of our regulatory activities and involves almost all the technical Directorates, namely: Investigation and Enforcement, Ports Inspection, Pharmacovigilance and Post Market Surveillance, Laboratory Services, Chemical Inspections, Food Safety and Applied Nutrition, Narcotics and Controlled Substances as well as Veterinary Medicines and Allied Products Directorate. The Agency has been highly proactive and vigilant in this regard. In our determined effort to combat SFs, Illicit Drugs and chemicals as well as unwholesome foods; the Agency has deployed multifaceted strategies which among others include: enforcement of regulation and control of APIs imported into the country to ensure they meet the required standards for manufacturing of drugs; reduction in Number of registered imported products and encouraging local manufacturing and innovation and overhaul of Pre-Shipment Clean Report of Inspection and Analysis of Imported Medicines and other NAFDAC Regulated Products. Other similar measures include deployment of Cutting-Edge Monitoring Technologies; Risk-based laboratory testing; Public Enlightenment on SFs, Inter-Agency, Inter-Professional Collaboration and Community Efforts and continuous Post-Marketing monitoring of quality of medicines.

It is also worthy to mention here that, following my relentless efforts which took the Agency back to the Ports in May, 2018 (all thanks to the Office of the National Security Adviser); coupled with rigorous inspection and enforcement activities; the Agency In collaboration with Nigerian Customs Service has seized and destroyed SFs, unwholesome foods and other unregulated products worth Four Billion, Two Hundred and Sixty Thousand Naira (N4,000,260,000) in exercises across the nation and Tramadol with estimated street value of about two trillion naira(N2,000,000,000,000). The impact is there. Most of the Tramadol merchants have gone underground. They have been almost decimated leaving only just few of them there. And we will continue to pursue them until they turn a new leave and abandon the dangerous trade. The street value of Falsified medicines and unwholesome food products and cosmetics seized and destroyed across the country by the Agency between March and August of 2021 alone stood at over N5billion.

Building Product Supply Chain Traceability Through Global Standards

Over the years, the Agency has evolved strategies to combat the ever-increasing challenge of regulated product counterfeiting and trafficking of substandard falsified medicines. While these strategies have yielded positive outcomes, the ever-innovative world of counterfeiting demands that new regulatory strategies be deployed to keep out these harmful products. This has led to the concept of building Traceability and Supply Chain Security into regulated products from plant to patient or from farm to fork.

The launching of pharmaceutical traceability strategy document was done in October, 2020 and it is the first step in positioning Nigeria to be a leader in driving traceability of pharmaceuticals in Africa. NAFDAC has developed a 5-Year Traceability Implementation plan in line with the objectives of the Nigeria Pharmaceutical Traceability Strategy to achieve supply chain visibility and strengthen its pharmacovigilance activities against the scourge of Substandard and Falsified Medicines and Medical Devices by the end of the year 2024.

The Agency has also established a Traceability Office (GS1 Desk) and a Technical Working Group to drive the activities in the 5-year implementation plan. NAFDAC is now using traceability to monitor distribution of vaccines across the country and the Agency is now leading globally in the use of this technology to monitor the vaccines. Oxford University recognized what NAFDAC is doing and referred to it as the “Abuja Principles” to mitigate falsification and counterfeiting of medical products



Emphasis on Local Manufacturing of Pharmaceuticals in Nigeria: NAFDAC has put a premium on local manufacturing of our regulated products to ensure that Nigeria will have drug security and turn the tide from 70% imports to about 30% imports by Year 2025. Part of the goal is to also mitigate SFs and counterfeiting since ensuring the quality is much easier compared to an imported product.  To enhance local production of pharmaceuticals in Nigeria, the Agency reviewed and updated its Five Plus Five-Year Validity policy. A product registration license is valid for 5 years and by the end of the 4th year of license validity, companies are required to submit draft blueprints of proposed partnerships with Nigerian companies or/and set up local manufacturing plant. Upon successful renewal for another 5 years for companies with verifiable blueprints, NAFDAC will monitor the migration of the imported drugs to local production. At the end of Year 7 (First 5 years + 2 years into renewal), if there is no progress on migration to local manufacturing as detailed in the blueprint, an alert for de-registration will be sent to the company at the beginning of year. The migration to local manufacturing will be limited to products the local manufacturers have capacity to produce or that partnership would enhance the capacity to manufacture. This is with a view to reducing the number of registered imported products and encouraging local manufacturing and innovation.

Local Herbal Medicines: NAFDAC has also placed emphasis on local herbal medicines by stepping down approval of imported herbal medicines that have equivalence in Nigeria. This is to create a renaissance of our herbal medicines and mitigate possible falsification and counterfeiting. In this bid, NAFDAC inaugurated the Herbal Medicine Product Committee in March 2019 and has fostered collaboration between herbal researchers and local practitioners. This has led to joint submission of research proposals for funding for clinical trials of products that have been given listing approval by NAFDAC so that the orduct can be given full approval.  

The Investigation and Enforcement activities of the Agency geared towards riding the country of menace of Substandard and Falsified Medical Products have yielded a lot of dividends. The arrests, prosecution, seizures and destruction activities recorded include the following: –

  • Interception and destruction of twenty-five (25) containers of Tramadol worth one billion, seven hundred and eight million, seven hundred and fifty thousand naira (N1,708,750,000).
  • Destruction of more than thirty containers of tramadol and other unregistered products worth more than 198 billion naira on the street
  • Three persons involved in the distribution of the banned Tramadol have been arraigned at the Federal High Court, Lagos.
  • The Agency secured the conviction of one of the distributors and the court ordered the destruction of the seized consignment.
  • Shut down of three pharmaceutical companies over poor distribution practice of codeine-containing syrup
  • The Agency arraigned the distributor of Codeine cough mixture exposed in a BBC documentary on Codeine abuse aired in May 2018 at the Federal High Court, Lagos. Prior to this, other persons had been arraigned for the sale and distribution of counterfeit Codeine-containing cough mixture. 
  • The Agency in an unprecedented move initiated the prosecution of an unrepentant advertiser of fake medicines with spurious and unsubstantiated claims in a National daily after a vigorous campaign against such illegal and dangerous activities.
  • In 2020, the Agency backlisted two companies from India that falsified a registered product and delisted the Nigerian company involved. In addition, six other local companies were shut down due to resistance to Good Manufacturing Practices compliance.
  • To further protect the health of consumers, the Agency destroyed fake, adulterated, counterfeit, banned and unwholesome NAFDAC Regulated Products worth four billion, two hundred and sixty thousand naira (N8,000,260,000) in exercises across the nation, while also clearing its Apapa warehouses that had been filled to the brim since 2013. 
  • Over twenty prosecutions of people responsible for counterfeiting or trading in substandard falsified medicines have taken place with most of them ongoing with a few fined or sentenced to imprisonment.

As a continuum of ensuring that SFs and counterfeited medical products are removed from the market, the Agency has procured 40 units of detection devices that can be used for on-the-spot detection of SFs in the market. NAFDCA will be the only agency in the world to go to this extent to rid the market of SFs.

Under this regulatory building block, NAFDAC was expected through the WHO Audit to satisfy 76 recommendations in 2018 and has of today fulfilled the requirements.


One of the benefits of my decision to revamp the ICT Unit is the digitalization of our registration processes. This allows our clients to register online through NAPAMS V2.0. We are currently implementing assisted e- registration of regulated products and palliative program for MSMEs. And as part of our Quality Management System (QMS) our processes are now SOP (Standard Operating Procedures) driven and we have updated our Regulations and Guidelines that were not reviewed for thirteen years (by June 2018). NAFDAC is also now enforcing submission of applications for Drug Product Approval using Common Technical Document (CTD) which was not always the case. As a result of these initiatives, we succeeded in clearing of 6000 backlog of registration applications by April 2018.


Digitalization of our registration processes afforded our clients continuous registration of their products during Federal Government COVID-19 lockdown.  Expedited pathways were also developed to handle COVID-19 related products to ensure processing of requests that met set standards to assure quality of products. Consequently, the Agency to date has granted administrative approvals to One hundred and eighty-five (185) alcohol-based sanitizers, three (3) face coverings/non-medical mask and One (1) Medical mask. It is worthy to state here that during this COVID 19 Pandemic; the Agency instituted the following palliative program for micro and small Enterprises (MSEs): Zero tariffs for first 200 MSEs, within a time lag; 80% reduction in tariffs for registration of MSEs products for a period of 6 months; waivers on admin charges for renewal of expired licenses for products of MSEs for 3 months. In compliance with he international best practices and our audit, NAFDAC has fulfilled the 147 recommendations for market authorization.  NAFDAC revamped its processing of applications.


The Agency had 119 recommendations to meet to satisfy in 2018. Today all have been met.

To effectively detect Adverse Drug Reactions (ADRs) as well as identify and mop up substandard regulatory products in circulation; we have adopted electronic reporting of ADRs for International Drug Monitoring and it is maintained by Uppsala Monitoring Centre in Uppsala, Sweden.  E-reporting allows the National Pharmacovigilance Centre to capture ICSRs directly from patients into Vigiflow (Database). It can also be accessed through the NAFDAC website. In addition, the Agency has procured and deployed Med Safety App for improved ADR reporting. The mobile phone application enables users to; report ADRs and other drug-related products experience, track drug-related safety information, build watch list of medications and view numbers of reports received in WHO database of suspected ADRs. The Agency has procured and deployed Med Safety App for improved ADR for improved reporting. The mobile phone application was launched on 4th November, 2020 and it enables users to;

  • Report ADRs and other drug-related products experience,
  • Track drug-related safety information,
  • Build watch list of medications,
  • View numbers of reports received in WHO database of suspected ADRs.

The agency is also collaborating with NPHCDA to see ways of getting real time AEFI and ADR data from their already existing SORMARS data platform. Several meetings have been held to see how their data platform can be interphased with WHO Vigiflow.


Inspection Of Pharmaceutical Manufacturing Facilities: Under my leadership, the Agency has sharpened its focus on increasing access to quality and efficacious medicines through local manufacture. Some of the successes in this area include the development of guidelines for Active Pharmaceutical Ingredient (API). The Agency through the support of our development partners carried out assessments of one hundred and sixty-five (165) Local Pharmaceutical Manufacturers in Nigeria with a view to developing a GMP Roadmap for NAFDAC and the pharmaceutical industry. The outcome enabled NAFDAC to make risk categorization of companies and advise on the path of GMP Certification and ensure compliance with respect to clinical sites respectively. Let me emphasize that promotion of local manufacturing has been on my priority list. This is to reverse the trend of 30% locally manufactured drug products toward 70%.  This building block has 106 recommendations that needed to be fulfilled. Through many self-audits, NAFDAC has met the expectations of the WHO Global Benchmarking requirements.


Laboratory Services: in 2018, about 80% of NAFDAC equipment pieces were not working and with that situation, ensuring the quality of medicines that are released or approved for use. Since 2018, NAFDAC laboratories are changing rapidly with improvement in new laboratory equipment and supplies. Over two-billion-naira worth of equipment have been procured.  The National Control Laboratory for Vaccines and Biologics got ISO-17025 Accreditation in February 2019 while the Kaduna Area Laboratory successfully got its ISO-17025 Reaccreditation in March 2019. Infrastructurally, the Yaba, laboratory complex was renovated and refurbished with new laboratory cabinetry and furniture, new access gates, clearing of blocked drainage system and the remodelling and rebuilding of the animal breeding facilities. NAFDAC’s Laboratories are being equipped gradually and have taken deliveries of brand-new laboratory equipment such as HPLCs, UPLCs, UV Specs, Karl Fisher Titrators, Micro Balances, pH Meters, GC, etc. In addition, a new Local Area Network was installed at the Yaba laboratory complex to aid the deployment of newly acquired Laboratory Information Management System (LIMS) and the VAISALA Environmental Monitoring Data Logger. I put premium on the state of our labs. This directorate is the mainstay of our business as a regulatory agency. A large chunk of our internally generated revenue also goes into funding of the laboratories across the country. COVID-19 intervention fund was also predominantly expended on procurement of necessary equipment for the labs.

About N997m of the COVID -19 intervention fund has been spent on the laboratory’s equipment. OPCW gave us N735m, and everything was spent on lab equipment.  As part of strengthening the Agency’s processes, the Yaba Drug and Biologics/Vaccine laboratories are currently being expanded and under construction.  Based on this continual improvement, the 114 recommendations have been met as of October 2021.


The Agency has improved greatly in this regulatory function and has satisfied the 53 recommendations requested by WHO

  • Development of a one stop shop link that houses all the relevant clinical trial guidelines
  • Development of a guidance document for conducting Clinical Trials during the early days of the COVID-19 pandemic  era in mid 2020.
  • Reduction of timelines for review of COVID-19 related trials (New molecule -15 Days while for repurposed medicine -10 Days).
  • Herbal Medicines: Skipping of Phase 1 study and in some cases Phase II studies for herbal. preparations with known safety and efficacy profile and those with Listing status by the Agency.
  • Increased collaboration with NHREC and Signing of an MoU with NHREC -2018.
  • Signing of MoU with Bio Ventures for Global Health (BVGH) for improved collaboration on capacity building for Clinical Trial Staff and Principal Investigators in the research space for the conduct and oversight of Oncology Clinical Trials.
  • Development of an Electronic Clinical Trial Application Platform (eCTAP) in collaboration with BMGF and NOVOTEQ for ease of submission of Clinical Trial Package and improved Transparency and tracking system of all application.
  • Adoption of the AVAREF Template for review of Clinical Trial application thereby making it easy for Nigeria participation in AVAREF and continental Joint Review.
  • Training of all Principal Investigators on NAFDAC regulatory process in 2019.
  • Implementation of the EDCTP Grant on  capacity building for NAFDAC and NHREC Staff on ethical consideration in providing regulatory oversight for Clinical Trials in Nigeria.
  • Development of an electronic system for prompt reporting of Serious Adverse Events occurring during Clinical Trials.
  • Developing Clinical Trials Specific Objectives and Key Performance indicators as a Quality.
  • Management tool for the evaluation of performance and needs assessment for Clinical Trial Staff.
  • Capacity building for four clinical trial staff on Clinical Trial Oversight from the center of regulatory excellence-(RCORE) in Accra- Ghana.


I am proud to inform you that, with the period I have led the Agency, NAFDAC has received the Outstanding Partnership Award during the 2nd MSMEs Awards Ceremony. The Agency has received award of the Nigeria Public Sector Productivity Award for Excellence in Effective Use of ICT To Propel the Productivity Frontier. Last year, your association, Health Writers Association of Nigeria gave me an award of Excellence. Just last week, Pak-Africa, gave me an award of Excellence in recognition of our contribution to ensuring the health of the nation through NAFDAC.

In conclusion, the achievements under my leadership are steppingstones that will soon lead to Nigeria manufacturing her own vaccines once WHO visits the Agency physically and declares the Agency ML3. We are working toward ML4 that will enable products approved by NAFDAC to be easily trade continentally and globally.  The foundation that is being laid through QMS and WHO GBT will lead to a regulatory agency built on legacy building blocks. 

 I must acknowledge and express my sincere appreciation to the Honourable Minister of Health, Dr. Osagie Ehanire, Honourable Minister of State for Health, Senator Olorunimbe Mamora, Chairman of NAFDAC Governing Council, Alhaji Suleiman Yusuf for their unalloyed support and guidance.

I am ever grateful to the Chairman of the Senate Committee on Health, Senator (Dr) Ibrahem Oloriegbe and his members, Chairman of House Committee on Health, Hon. (Dr) Tanko Yusuf Sununu and his members for their unwavering support.

I also thank my ever-hardworking NAFDAC Staff, our various Stakeholders, the mass media and our various well-meaning Nigerians whose co-operation and support enabled us to record these modest successes so far.

Thank you all for your rapt attention.

Director General

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