OVERVIEW OF THE DIRECTORATE

Drug Evaluation and Research Directorate (DER) of NAFDAC was created out of the defunct Establishment Inspection Directorate (EID) in March 2013 occasioned by need for refocusing, specialization and research. The focus of the Directorate is on Good Manufacturing Practice, Good Clinical Practice and Good Storage Practices.

Our scope covers regulation of the manufacture of pharmaceuticals including biopharmaceuticals, herbal medicines, cosmetics, and medical devices as well as oversight on clinical trial activities including the trial sites both locally and internationally. The headquarters of the Directorate is located at NAFDAC Office Complex, No.1, Industrial Estate, Oshodi-Apapa Expressway, Isolo, Lagos.

The Directorate comprises of five (5) Divisions namely: Clinical Trials, Vaccines & Biologics, Cosmetics & Medical Devices, Herbal Medicines & Nutraceuticals, Pharmaceutical Compliance, and Pharmaceutical Operations Divisions. The Directorate is headed by a Director, resident at the headquarters and has a pool of highly skilled and experienced staff comprising of management, regulatory and administrative cadres. The office of the Director houses the Quality Management System (QMS) Unit.

WHAT WE DO

DER Directorate has the mandate to ensure that only quality, safe and efficacious pharmaceuticals, vaccines, biologics, herbal medicines, nutraceuticals as well as cosmetics and medical devices are available to the public.

To achieve this mandate, the Directorate carries out the following activities;

• Conduct Good Manufacturing Practice (GMP) assessments of all domestic and foreign plants that produce pharmaceuticals, vaccines, biologics, herbal medicines, and nutraceuticals as well as cosmetics and medical devices.
• Certification of the production sites of regulated products on compliance of the sites with the applicable regulations and guidelines.
• Monitor continued compliance of manufacturing sites with relevant regulations and guidelines through appropriate inspection activities.
• Monitor Good Storage Practices (GSP) of facilities engaged in the storage and distribution of vaccines and other biologics.
• Review of clinical data submissions for new chemical entities and generic medicines.
• Review of clinical trial protocols
• Grant authorization for conduct of clinical trials upon compliance with relevant requirements.
• Conduct Good Clinical Practice (GCP) inspection of clinical trial sites for compliance with approved protocols.
• Develop and communicate relevant guidance documents to enable compliance of regulated industry with applicable regulations and requirements.
• Liaise and collaborate with relevant establishments within and outside Nigeria in pursuance of the functions of the Agency as they relate to the mandate of the Directorate.

HOW WE DO IT

• The use of integrated quality assessment teams comprising of trained, experienced and highly-skilled staff.
• Implementation of a Quality Management System (QMS) to assess strengths, weaknesses, and opportunities in the system and institute improvement measures through customer feedback and other improvement tools for efficient service delivery.
• Use of technical working groups
• Use of the 3L approach:
  • Legislation: the enabling law, regulations, and relevant guidelines.

• • Location: On-site GMP audit of manufacturing facilities for pharmaceuticals, cosmetics, medical devices, herbal medicines, and clinical trial sites both local and internationally
  • Learning: Training and mentoring of staff and regulated industry.

• Proper planning of inspection activities and due scheduling.
• Use of risk-based approach for evaluation of GMP status of facilities
• Issuance of Authority to Manufacture and GMP Certificates
• Application of sanctions for regulatory violations.
• Consultative meetings and other engagements with stakeholders e.g., periodic meetings with the sectoral groups.
• Create and sustain communication channels with stakeholders to drive compliance.
• Facilitating capacity building programs for stakeholders e.g. organization of trainings and workshops for stakeholders such as the API and Excipient Manufacturing workshop held in October 2023.

WHEN WE DO IT

DER Directorate carries out its activities when conducting the following types of inspections:

• Production Inspection
• Announced/Unannounced Routine Inspection
• GMP Reassessments (Licence Renewal, unsatisfactory laboratory analysis & Product re-formulation.)
• Pre –Registration Inspection
• Follow-up (CAPA Effectiveness Verification) Inspection
• For Cause (Investigative) Inspection
• Monitoring Inspection (Overprinting of MAS Codes on product packs, local printing of NAFDAC Reg. No. on imported products)
• GCP Inspection
• Cold Chain Storage Facility Monitoring

WHERE WE DO IT

Facilities Regulated by DER Directorate Nationwide (as at January 2024)

WHERE WE ARE GOING

• To empower and develop staff of the Directorate to the level of Subject Matter Experts in different areas.
• To become a global reference inspectorate.