Registration And Regulatory Affairs Directorate

The functions of the Registration and Regulatory Affairs Directorate are :

  • Registration of drugs, foods, medical devices, cosmetics, chemicals, detergents, drinks and bottled and packaged water.
  • Formulation and periodic review of regulations to control products registration by the Agency.
  • Processes and manages all documents relating to the clinical trials of novel drugs and new chemical entities.
  • Monitors clinical trial to ensure compliance with clinical trial study protocols in order to safeguard the health and safety of the trial participants.
  • Ensures that only drugs of proven safety and efficacy are allowed to be manufactured, imported, sold or distributed in Nigeria.
  • Reviews directly or indirectly (by use of experts) published reports on clinical trials.
  • Conducts scheduled and unscheduled visits to trial sites for the purpose of audit before, during and/or after the completion of the study.
  • Development of modalities for certification of food items for export.
  • Attending and holding consultative meetings on behalf of the Agency both within and outside Nigeria.
  • Control of advertisement of regulated products.
  • Investigation of consumer complaints and post registration surveillance activities to ensure that products still meet registration standards.
  • Processing applications for global listing of supermarkets/restaurants/fast food items (GLS).
  • Coordination of foreign cGMP inspections.
  • Organizing workshops and training for staff of the Agency as well as other relevant stakeholders.