Dr. Sheku Suma Manasaray
Head of Drug Evaluation & Registration Department Email: ssmansaray@pharmacyboard.gov.slBio:Dr. Sheku Suma Mansaray is the Senior Regulatory Officer and Head of the Drug Evaluation and Registration Department at the Pharmacy Board of Sierra Leone. With over a decade of experience in pharmaceutical regulation pharmacovigilance and academic leadership he oversees the evaluation registration and regulation of medicines and ensures compliance with national and international standards.
Dr. Mansaray holds a Doctor of Pharmacy (PharmD) from the University of Benin Nigeria and is a Fellow of the West African Postgraduate College of Pharmacists in Public Health. His qualifications also include a Master of Science in Pharmacology (University of Sierra Leone) and a Postgraduate Diploma in Research Methodology Epidemiology & Biostatistics from USL and Harvard University. His extensive academic and professional expertise equips him to lead regulatory initiatives promote drug safety and support evidence-based pharmaceutical policies in Sierra Leone.
The Drug Evaluation and Registration Department (DERD) is one of the key departments within the Pharmacy Board of Sierra Leone. It provides strategic oversight and operational management for the evaluation registration and regulation of medical products.The department ensures that all products including allopathic medicines medical devices and in-vitro diagnostics biologics and vaccines vector control products cosmetics nutritional agents food supplements comply with national guidelines and international best practices.This strengthens regulatory oversight and ensures the safety efficacy and quality of products used in Sierra Leone.
Scope:
The DERD regulates medical products through established guidelines and standard operating procedures ensuring that all medicines and other regulated products manufactured imported exported distributed or utilized in the country meet the required standards of quality safety and efficacy.
Objectives:
The main objective of the department is to ensure that all regulated products are of good quality fit for human consumption and safe for use. Specific objectives include:
i.Conducting pre-assessment of all samples dossiers and completed application forms for new product registrations as well as for renewals.
ii. Issuing Marketing Authorization Certificates through thorough evaluation of product dossiers and samples.
iii. Reviewing applications for product variations and advertisements providing approval where appropriate.
iv. Vetting and ascertaining the eligibility of pharmacy professionals to practice in Sierra Leone ensuring all requirements are met.
v.Regularly updating existing guidelines and developing new ones in line with international standards to enhance departmental operations.
Units of the Department:
Mrs. Nancy Oluwakemi SamaiHead of Pre-Market Unit (Regulatory Officer 1) Email: nosamai@pharmacyboard.gov.slBio:Nancy Oluwakemi Samai is a Regulatory Officer 1 and Head of the Pre-Market Unit at the Pharmacy Board of Sierra Leone. Since joining the Board in January 2023 she has played a key role in ensuring that pharmaceutical products meet national regulatory standards before entering the market. With hands-on experience in drug evaluation and registration she supports the implementation of regulatory frameworks that promote public health and patient safety.
Nancy holds a Bachelor of Pharmacy Degree with Honours from COMAHS University of Sierra Leone (2019) and is currently pursuing professional certification with the West African Postgraduate College of Pharmacists (Part 1 Level 1 Social and Administration). She is also an active member of the Pharmaceutical Society of Sierra Leone and the Young Pharmacist Group contributing to professional development and advancing pharmacy practice in Sierra Leone.
The Pre – market Evaluation unit was established for the purpose of receiving and processing applications for product registration. It conducts a pre – assessment of samples dossiers and filled application forms submitted for product registration.
- Mr. Daniel Osman TurayHead of Marketing Authorization/Post-Market Units (Regulatory Officer 1) Email: doturay@pharmacyboard.gov.slBio:
Daniel Osman Turay is the Regulatory Officer 1 and Head of the Marketing Authorization/Post-Market Units at the Pharmacy Board of Sierra Leone. With more than a decade of experience in pharmaceutical regulation inspection and post-market surveillance he leads the evaluation and monitoring of medicines and related products to ensure their quality safety and efficacy across the country. He began his career as a Pharmacy Technician with the Ministry of Health and Sanitation in 2011 and joined the Pharmacy Board in 2012 as an Assistant Regulatory Officer in the Drug Evaluation and Registration Department. After completing his Bachelor of Pharmacy Degree in 2018 he returned to the Board as an intern pharmacist and later advanced to Inspecting Pharmacist and Regulatory Officer 1 in 2021.
Mr. Turay holds a Diploma in Pharmacy (COMAHS USL 2010) a Bachelor of Pharmacy Degree with Honours (COMAHS USL 2018) and a Master’s degree in Drug Regulatory Sciences from the University of Lagos Nigeria (2023). He is currently pursuing professional certification with the West African Postgraduate College of Pharmacists (Part 1 Level 1 Social and Administration) and is an active member of the Pharmaceutical Society of Sierra Leone and the Young Pharmacist Group contributing to the development of pharmacy practice and regulatory science in the country.
The Marketing Authorization unit is responsible for the evaluation of application for product registration and to decide whether approval for Marketing Authorization should be granted. The approval for marketing authorization is usually based on the result of the Quality Control Analysis and Dossier Evaluation report and the Board’s minimum requirements for product registration. This unit also processes applications for the renewal medicinal and other related products. It also collates/prepares report of applications for product registration for the attention of the product registration committee which is a technical subcommittee of the Drugs and Quality Assurance (DQA) Committee. The product registration committee in turn provides recommendation to the DQA as to whether or not approval could be granted. In addition the list of registered products is compiled by this unit for onward dissemination to other line departments of the Board.
The Post – market Evaluation unit is responsible for the receipt and processing of all applications for variation or advertisement of registered products. The unit works in collaboration with both the Factory Inspectorate and Import Control and Pharmacovigilance/Clinical Trial departments in conducting post market surveillance for the identification of both registered and unregistered products. It also vets pharmacy professionals’ eligibility to practice in Sierra Leone.