NAFDAC meets 119 WHO global benchmarking tool recommendations ― DG

The Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye has said the Agency has met all 119 World Health Organization(WHO)Global Benchmarking Tools(GBT) Recommendations to effectively detect Adverse Drug Reactions(ADRs).

Adeyeye in her Address to mark 4th Year Anniversary narrated her experience as the DG of the Agency in the past four years said in 2018, the Agency had 119 recommendations to meet and today all have been met.

Adeyeye said to effectively detect Adverse Drug Reactions (ADRs) as well as identify and mop up substandard regulatory products in circulation, the Agency have adopted electronic reporting of ADRs for International Drug Monitoring and it is maintained by Uppsala Monitoring Centre in Uppsala, Sweden.

According to Adeyeye: “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.

Adeyeye further disclosed that 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”.

On Inspection Of Pharmaceutical Manufacturing Facilities, Adeyeye said, Under her 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”.

She also emphasized that promotion of local manufacturing has been on her 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”.

On Laboratory Services, Adeyeye said 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”.

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