By Chimezie Godfrey
The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Dr Mojisola Adeyeye has said that achievements made by the agency will soon lead to Nigeria manufacturing her own vaccines.
She revealed this to newsmen at a press conference held in commemoratation of her four years in office on Tuesday in Abuja.
Dr Mojisola who gave gratitude to God for His mercies, benevolence, guidance and preservation, said the flurry of events, regulatory activities, challenges, opportunities and achievements in the last 4 years led NAFDAC through charting a new course to where the Agency is at present.
She noted that under her leadership the agency has lived up to expectations in realizing the goal of the last four years which include – to 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.
Speaking on ISO 9001:2015 Quality Management System Certification, she disclosed that under her leadership, Quality Management System (QMS) has been entrenched in the Agency with all “our processes procedure driven.”
She said the Agency was ISO 9001:2015 Certified in June 2019 and that NAFDAC has been received recertification in 2020 and 2021, adding that this continued recertification is based on continual improvement (self-audit) in regulatory culture to always put the customer first. Dr Adeyeye revealed that on the WHO Benchmarking Programme (ISO 9004) commenced in January 2018 the agency has 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: “WHO GBT – National Regulatory System Block. In January 2018 NAFDAC had 186 recommendations to satisfy. About a month ago, the Agency had fulfilled all the recommendations.
“WHO GBT – Market Surveillance and Control Building Block.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.
“WHO GBT – Registration and Marketing Authentication Block. 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).
“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,” she said.
The NAFDAC DG further said that part what the agency had put on ground include WHO GBT – Regulatory Inspection Block, WHO GBT – Laboratory Testing Block, and WHO GBT – Clinical Trial Oversight Block,
She said,”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 which include -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.
“Others are 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, and 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.
“Also, 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, and capacity building for four clinical trial staff on Clinical Trial Oversight from the center of regulatory excellence-(RCORE) in Accra- Ghana.” Dr Adeyeye disclosed that the agency under her leadership received several recognitions and commendations. “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.,” she said.