Drug Firms, Authorisation Holders Delaying Greenbook Update – NAFDAC
The National Agency for Food and Drug Administration and Control (NFDAC) has blamed pharmaceutical companies and marketing authorisation holders for delaying updates to its Greenbook.
The agency made this known on Tuesday at the opening of a two-day sensitisation and awareness workshop in Lagos.
Speaking on behalf of the Director-General, Prof Mojisola Adeyeye, the Director of Post-Marketing Surveillance, Fraden Bitrus, said several products registered by NAFDAC are not yet visible on the Greenbook platform because companies have not submitted all the required data.
“Some products are registered but not yet visible on the Green Book because their marketing authorisation holders have not submitted the required information,” Bitrus said.
He urged all drug manufacturers and importers to urgently comply, warning that the delay hinders public access to information on approved medical products and weakens regulatory transparency.
Bitrus described counterfeit medical products as a man-made evil driven by greed. “These counterfeit products are produced by greedy businessmen and their international collaborators who only want to make money. It is one of the worst forms of inhumanity from man to fellow man,” he said.
He highlighted NAFDAC’s ongoing interventions, including consumer safety publications, daily newspaper alerts on fake drugs, the Shine Your Eye programme on national TV, and the use of digital tools like TrueScan and Media Lab.
On the Pharmaceutical Products Flexibility Regulation 2024, Bitrus said the system will allow every regulated product, whether imported, exported, manufactured or distributed in Nigeria to carry a unique identifier, enabling full tracking through the supply chain.
He added that Nigeria is the first country in Africa and second globally to adopt this traceability technology, first piloted during the COVID-19 vaccine rollout.
Bitrus also said the new Preventive Regulation 2024 was introduced to address the special drug needs of children and improve paediatric medicine oversight.
Also speaking at the event, NAFDAC’s Director of Southwest Zone, Mrs Rose Ajayi, said the workshop was designed to ensure that participants leave with a deeper understanding of recent developments in drug product regulation, especially concerning paediatric formulations.
“At the end of this workshop, we expect that participants will be well-informed about the recent developments on drug product regulation, with emphasis on paediatric formulations,” Ajayi said.
She added that the training would equip attendees with knowledge of how to properly use the NAFDAC Green Book.
