The Nigerian drug manufacturers will now have to register on the new online portal before their drugs are allowed to enter into the country; thanks to the National Agency for Food and Drug Administration and Control (NAFDAC) who has made sure the portal is accessible.
The Director-General of NAFDAC, Dr Paul Orhii, said that firms which are initiating registration online for their products can monitor progress online, but will have to maintain a local partner to provide samples for laboratory testing.
He said that KIM, which is a pharmaceutical consulting firm operated by NAFDAC’s ex-head of evaluation and monitoring, Hauwa Keri, “prompted the agency’s stance to have more experienced pharmaceutical experts start consultancies that can help potential partners abide by the guidelines of the drug and food regulator.
KIM and its Portugal-based partners are making a foray into the Nigerian drug market and are pioneering NAFDAC’s drive of online registration which ensures that the agency’s work becomes “more transparent and predictable.”
KIM’s partners—Basi Laboratorios and Jaba Recordati, both based in Portugal—are looking to “develop a market where Nigeria is the focus,” said Joaquim Chavez of Basi.
The firm, which commenced official registration last year, “is looking to provide its range of drugs—for cardiovascular ailments, women and children—on the Nigerian market at the standards of European consumers, hence its emphasis on quality control and pharmacovigilance,” Chavez said.
He added that Nigeria was “one of the most relevant markets we will have in future.”
“Applicants must provide information on companies, including short and full company name, mailing address, premises address, phone, fax, contact/responsible officials, operating licences and their validity, authorization to act as applicant/licence holder for drug registration purposes, authorization for psychotropic/narcotic drugs among other requirements,” Chavez said.
The World Health Organisation (WHO) also recommended that summary information on inspections carried out at company premises, separate records for each individual activity that a company carries out and preparation of inspection programmes based on a variety of user-defined criteria encompassing geographical area, type of company activity, type of items characteristics of inspectors and degree of risk identified for each premises be provided.