VACCINES, BIOLOGICAL & MEDICAL DEVICES 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 Benin 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 BSO Benin 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 Benin.

The BSO Benin 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 BSO Benin 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 BSO Benin 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 Benin

-Guidelines for Vaccines, Biological & Medical Devices laboratory Practice in Benin
-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 BSO Benin, laboratory Trials Department as a Regional Centre of Regulatory Excellence in laboratory trials since 2014.