Notice To Clients On NAFDAC Guidelines For The Preparation Of Summary Of Product Characteristics (Smpc) For Drug Products In Nigeria (Human Drugs)
Dear Esteemed Client, This is to inform all Certificate of Product Registration Holders for human medicines that NAFDAC has developed a Guideline for the preparation of Summary of Product Characteristics (SmPC). The NAFDAC Drugs and Related Products Registration Regulations and NAFDAC Drugs and Related Products Labelling Regulations require that drug product registration application include labelling […]
NAFDAC Ceiling List
This is to inform the public that the National Agency for Food and Drug Administration and Control (NAFDAC) has updated the NAFDAC Ceiling List. The Agency will no longer accept new application for registration of imported pharmaceutical products on the list. Renewal applications will be processed following the 5+5 policy pathway, in which applicants at the […]
Use of Online Platforms And Digital Tools
As the COVID-19 pandemic continues with its consequential effects on daily activities and more especially in workplace interactions, the Drug Evaluation & Research (DER) Directorate of NAFDAC has found it imperative to inform our stakeholders of the measures being put in place to limit the risks associated with the spread of COVID-19 disease As a […]
Public Announcement: Instructions on CRIA during this lockdown #04201
As a result of the difficulties experienced during inspection and sampling for CRIA due to the lock down in India, the following below is approved to guide Manufacturers, Exporters and Importers of NAFDAC regulated products from India; NAFDAC MANAGEMENT
Post Marketing Surveillance On Food, Drug And Other Regulated Products #12191
The National Agency for Food and Drug Administration and Control (NAFDAC) hereby informs manufacturers and manufacturers’ representatives to put a suitable post marketing surveillance system in place to effectively monitor the quality and safety of products that they register with NAFDAC. Annual reports on post marketing surveillance activities should be submitted to the Director-General (NAFDAC), attention: Director, […]
Full Implementation Of The Common Technical Document (CTD) Format #11191
The Director General (NAFDAC) has approved June 1st, 2020 for full implementation of the Common Technical Document (CTD) format requirement for submission of product dossiers in support of Marketing Authorization (MA) applications in line with the Agency’s transition policy to CTD dossier submissions. This is an extension of 28 months from the previous deadline of […]
Active Pharmaceutical Ingredient(S) Import #10191
All pharmaceutical companies who intend to import Active Pharmaceutical Ingredients (API) can import without any categorization henceforth. However, all API import must have Drug Master File (DMF) or Active Substance Master File (ASMF). The DMF /ASMF should be directly sent or made available in electronic copy to Director, Drug Evaluation and Research. The DMF or […]
Pre-Shipment Provisional Registration Of Imported Drugs And Other NAFDAC Regulated Products #07192
The National Agency for Food and Drug Administration and Control (NAFDAC) hereby informs the public, especially manufacturers and manufacturers’ representatives that drugs and other regulated products approved by the Agency for registration and renewal will henceforth be granted provisional registration pending confirmation of quality of two batches/lots of the products. This measure has become necessary […]
Issuance Of E-Permit For Excipients #07191
In line with our commitment for continual improvement and process harmonization in service delivery, I wish to notify our stakeholders that e-permit for importation of ALL excipients will be issued by Chemical Evaluation and Research Directorate (CER). In view of this, all requests for e-permit to import excipients should be made through CER online portal. […]
Commencement Of Five Plus Five Year Validity (Migration* To Local Production**) #03191R
We wish to inform all Holders of valid marketing authorization and all new applicants for registration of imported pharmaceuticals in Nigeria that the Agency has commenced implementation of the five plus five (5 + 5) year validity policy. Henceforth, newly approved registrations and renewals will always have the footnote on five plus five validity requirements. […]
