1st Floor NAFDAC Office Complex Plot 1, Isolo Industrial Area Oshodi-Apapa Expressway Isolo, Lagos State.
Drug Evaluation and Research (DER) DirectorateAbout Drug Evaluation and Research Directorate
WHO WE ARE
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 pharmaceutical, herbal medicines, cosmetics, biopharmaceuticals, medical devices and clinical trial facilities 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 Six (6) Divisions namely: Clinical Trials & Drugs, Cosmetics & Medical Devices, Pharmaceutical Compliance, Herbal Medicines & Nutraceuticals, Vaccines & Biologics and Quality Management System (QMS). 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.
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, DER 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.
- Evaluate dossiers of drug products intended for registration by the Agency.
- 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 all over the country
- 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 with stakeholders
- Create and sustain communication channels with stakeholders to drive compliance.
WHEN WE DO IT
DER Directorate carries out its activities when conducting the following types of inspections:
- Production Inspection
- Announced Routine Inspection
- GMP Reassessments (Licence Renewal, unsatisfactory laboratory analysis & Product re-formulation.)
- Investigative Inspection
- Monitoring Inspection
- Pre –Registration Inspection
- Follow-up Inspection
- GCP Inspection
- Cold Chain Storage Facility Monitoring
WHERE WE DO IT
Facilities Regulated by DER Directorate Nationwide (as at May 2018)
|S/N||Local Pharmaceutical Facilities||Herbal Medicines & Nutraceuticals Facilities||Cosmetics & Medical Devices Facilities||Cold Chain Storage Facilities||Clinical Trial Sites|
WHERE WE ARE GOING
- To empower and develop staff of the Directorate to the level of Subject Matter Experts.
- To become a global reference inspectorate.