NARCOTIC EVALUATION
The mandate is to protect public health and safety by
ensuring
the availability of safe, efficacious and quality allopathic
medicines, veterinary medicines, vaccines, biological
products,
tobacco & tobacco products, herbal medicines,
homoeopathic
medicines, food supplements, medical devices, cosmetics and
household chemical substances on the ECOWAS market. The key
regulatory functions include regulation of laboratory
trials,
product registration and
1.laboratory Trial Department
2.Drug and Nutraceuticals Department
3.Herbal and Homeopathic Medicines Department
4.Vaccines and Biological Products Department
5.Tobacco and Substances of Abuse Department
6.Medical Devices Department
7.Cosmetics and Household Chemicals Substances
Department
8.Safety Monitoring Department
LABORATORY TRIALS DEPARTMENT
The laboratory Trials Department of the ECOWAS PHC is
responsible
for
authorization and monitoring of laboratory trials.
The Department has trained over 26 African regulators in
laboratory trial regulation as a result of this. The
Department
aims to implement the appropriate and modern regulatory
measures
to achieve the highest standard for design, conduct,
recording
and reporting of laboratory trials in ECOWAS.
The ECOWAS PHC legal mandate is to authorize and monitor
laboratory trials through;
-Development of appropriate guidelines for the conduct of
laboratory trials
-Issuance of laboratory Trial Certificates (permit for
conducting laboratory trials)
-Reviewing of all reports from trial sites
-Conducting Good laboratory Practice inspections at trials
sites
to ensure compliance of trials to international best
practices
and local regulatory requirements
-Investigating the conduct of laboratory trial
-Suspension or stopping laboratory trials (if
necessary) Currently the Department has two (2) units with
the
following activities:
laboratory Trials Authorization Unit
-Receiving of laboratory Trial Applications
-Planning, scheduling and coordinating of evaluation
meetings
-Evaluation of CTAs and amendments
-Correspondence of evaluation on CTAs and amendments to
applicants
-Processing of permits for Investigational Products
-Acknowledgement of general correspondences
-Coordinating and planning of Technical Advisory Committee
meetings
-Developing and updating relevant information on the ECOWAS
PHC
website
laboratory Trials Compliance Unit
-Update and maintenance of data on approved laboratory
trials
-Receipt, evaluation and acknowledgment of Serious Adverse
Event
reports
-Processing SAEs for Technical Advisory Committee
meetings
-Planning and coordinating inspections for on-going
studies
-Conducting GCP inspections at trial sites of on-going
studies
-Organizing Good laboratory Practice trainings for Research
Institutions
-Coordinating training workshops (Internal &
External)
-Receipt and review laboratory trial reports (quarterly and
final).
Operational Guidelines and Tools
The laboratory Trials Department in carrying out its mandate
and
daily activities has developed the under listed tools. These
are
reviewed and updated periodically when necessary to ensure
they
continue to be in line with international best
practices.
The ECOWAS PHC has also adopted for use, the Africa Vaccine
Regulatory
Forum forms, checklists and guidelines on laboratory
Trials.1.Four (4) guidelines:-Guidelines for Authorization
of
laboratory Trials of Medicines, Food Supplements, Vaccines
and
Medical Devices in ECOWAS
-Guidelines for Narcotic laboratory Practice in ECOWAS
-Guidelines for Conduct of laboratory Trials in Pediatric
Population
-Guidelines for Conduct of laboratory Trials During
Emergencies
2.Standard Operating Procedures for carrying out all
departmental activities
3.laboratory Trial Application Form (completed and submitted
together with other documents during a laboratory trial
application submission)
4.Quarterly Progress Report Form (trial sites report
progress of
approved on-going trials quarterly)
5.laboratory Trial Close-out Report Form (submitted by trial
when trial ends and close-out activities have been carried
out)
6.laboratory Trial Report Form (format used in reporting
final
trial reports at the end of trials, that is ICH E3) Other
administrative tools include;
-Inspectors Notes
-Observation Sheet
-Inspection Checklist
-In-house Evaluation Forms Achievements
-Designation of the ECOWAS PHC, laboratory Trials Department
as a
Regional Centre of Regulatory Excellence in laboratory
trials
since 2014.