Overview of R & R
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.
Registration and Regulatory Affairs (R & R) Directorate
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