The National Agency for Food and Drug Administration and Control (NAFDAC) has said that, contrary to opinion in some quarters, Nigerians now have improved access to locally produced safe, efficacious and affordable medicines, even those that were hitherto not produced in Africa.
Speaking during Common Technical Document (CTD) workshop organised by NAFDAC in Lagos, the agency’s Director General, Dr Paul Orhii, stated that the technical assistance given by the agency towards the production of at least four United Nations Life -Saving Commodities for women and children has partly made it possible for Nigeria to have improved self-sufficiency in drug production.
Orhii, who was represented by the agency’s Director, Registration and Regulatory Affairs, Dr Monica Hemben Eimunjeze, listed some of those locally produced drugs that have put Nigeria on a high pedestal to include chlorhexidine gel used in neonatal umbilical cord care, amoxicillin dispersible tablet (D.T) used in pneumonia treatment and zinc sulphate for the treatment of diarrhoea.
The CTD, which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries, is a set of specification for application dossier for the registration of medicines.
Orhii, who stated that the agency has adopted the West African Organisation (WAHO) CTD format for the West African sub-region, stated that the new format has helped the agency to perform beyond the hitherto 26 Chapter Dossier Format, “which was not as organised as the CTD modular structure.”
Orhii listed the benefits of the new CTD to include complete and well-organised submissions, more predictable format, more consistent reviews, easier analysis across applications, easier exchange of information, faster review times for applications and facilitation of electronic submission.
The NAFDAC DG added that international collaboration has boosted the efforts of the agency towards obtaining international best practices.
Orhii said: ” The agency has fostered collaboration with relevant international organisations to support its drive to ensure processes are in line with best global practices.
These include our engagements with the World Health Organisation (WHO) through our participation in the collaborative procedure for registration of WHO Prequalified Medicines as well as Expedited Procedure for Registration of WHO Prequalified Vaccines.”