EVALUATION AND REGISTRATION - Liberia Medicines And Health Products Regulatory Authority (LMHRA)

EVALUATION AND REGISTRATION DEPARTMENT

Upon the establishment of the LMHRA, the Products Evaluation & Registration Department embarked on listing of Pharmaceutical products for human use in 2011. In 2012, with support from a consultant (Mr. Ben Botwe) from Ghana, the department began registration of medicinal products in Liberia. Currently, the department uses the ECOWAS agreed CTD protocol for dossier submission as ECOWAS member state for the harmonized registration procedure established through the efforts of the West African Health Organization (WAHO) in the ECOWAS region.

In adherence to the ACT of 2010 which provides the provision for the Registration of all medicinal Products in circulation in the pharmaceutical sector in Liberia, the department has moved to conduct:

Full assessment for the registration of allopathic medicines
Assessment for the registration of Herbal medicines and supplements
Assessment for medical devices listing gearing to registration
Listing of Health Products (Cosmetics)

The Department is yet to begin registration of Biosimilar medicines (Biological and Blood related substances and Psychotropic substances)

Pharm. Patricia Quaye-Freeman is the Director of Registration and Evaluation at the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and is married to Mr. Edwin Y. Freeman with three (3) beautiful daughters.

She is a 2010 graduate with a BPharm degree from the School of Pharmacy (University of Liberia), and a 2003 graduate from the University of Liberia with a BSc Degree in Zoology. She obtained her high School certificate in 1995 from the St. Michael Catholic High School in New Georgia.

Upon obtaining her B. Pharm., she joined the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and was assigned in the department of Registration and Evaluation; where she worked vigorously as Deputy Director for couple of years.

She has obtained a lot of trainings that has made her effective as a senior Regulator. She did her first training in Ghana, 2013, on the West African Registration Harmonization Dossier Evaluation. Additionally, she has attended a lot of other trainings in Ghana, Nigeria, Tanzania & India, covering the following topics but not limited to: Introduction to Regulatory submissions and CTD; WAHO CTD requirements and formats for dossiers and evaluation reports; WAHO CTD formats for Application, Evaluation, Registers, Inspection, Quality Control; Quality Management System – Necessary tool for Regulatory Authorities International Conference on Harmonization (ICH) & and other Harmonization Schemes; WAHO CTD format for manufacturing facility inspection and quality control assessment.

All of these trainings were centered on Regulations. She was amongst the first batch of staff trained 2012 to conduct the First Dossier Evaluation by Benjamin Botwe. After the 2012 training, coupled with other international trainings, she has being evaluating dossiers and has also helped in training new staff within the department.

In addition to her education, she attended some Institutions and obtained certificates in other disciplines which include: Pastry Making; Tie and Dye; Tailoring and Driving.

Director Patricia Quaye-Freeman has served the LMHRA and has played a significant role in getting the entity where it is now; mainly the registration of products on the Liberian market.

Overview

The Product Evaluation & Registration Department is one of the four technical departments of the LMHRA with the responsibility to receive applications for (medicines and health product) registration and provides feedback to applicants on the registration process; conduct evaluation of product dossiers; generate information for billing (i.e. payment for products registration, listing of medical devices, cosmetics, health products and pre-market analysis); prepare Market Authorization (Import/Clearance); list medical devices, health products, and cosmetics; publish registered products; conduct regular workshops for clients – i.e. Importers, Pharmacists, etc. for information sharing; and generate and update registration guidelines and related documents.

structure

The Evaluation and Registration Department is headed by an astute Pharmacist, Mrs. Patricia Quaye-Freeman as Director, assisted by Pharmacist Mary Jalloh-Tozo as Deputy Director and seven unit managers. The Department comprises of the following Units: Reception, Medicines Registration, Cosmetics Registration, Medical Devices Registration, Research & Development, Records Management and Narcotics & Psychotropic Registration Units.

Pharm. Mary G. Jalloh-Tozo is a registered Liberian Pharmacist presently working at the Authority, serving as Deputy Director of the Evaluation and Registration Department.

Pharm. Mary G. Jalloh-Tozo obtained a Bachelors of Pharmacy (BPharm) at the University of Liberia School of Pharmacy, a Bachelors of Science in Biology and Chemistry at the TJR Faulkner College of Science and Technology, University of Liberia and a graduate of the Nzerekore Refugee School, Republic of Guinea.

She has worked for the Authority for eight years in different capacities: 2012 -2015 as assistant regulatory officer; 2015-2018 as manager/focal person for listing of medical devices and American and European products.

Pharm. Mary G. Jalloh-Tozo is a professional regulator and has also benefited from several local and international trainings in Ghana and Nigeria: Certificate of participation, Dossier Evaluation and Medicines Registrations, CePAT, Ghana; Certificate of participation, Medicines Registration Harmonization and Twinning, NAFDAC, Nigeria; Certificate of Participation, Medicines Registration and Dossier Compilation Training, USP, Ghana; Certificate of completion, Successful Completion of Training in Dossier Evaluation, USP/USAID, Liberia; Certificate of Completion, Successful Completion of Training in Good Manufacturing Practices (GMP), USP/USAID; Certificate of Participation, Training of Trainers workshop for Accredited Medicine for Sustainable Drug Seller Initiative (SDSI), Monrovia, Liberia.

She’s married with 2 kids.

reception unit

Receives all application for Registration of all Pharmaceuticals and processes them, including:
- raising of bills for payment of nonrefundable fees;
- processing of the application;
- Attach IP/Processing form, Bill Request, Invoice & Payment Receipt;
- Submits application to Research Team.

Medicine Registration Unit:

Receives all applications for Registration of all Pharmaceuticals from the Reception Unit;
Conducts check lists for all medicines;
Conducts screening and preliminary evaluation;
Communicates preliminary evaluation findings to Applicant;
Receives feedback;
Codes all Pharmaceutical products;
Conducts assessment for evaluation of dossiers.

Cosmetic Unit

Receives all application for listing of Cosmetics;
Performs checklist for the listing;
Conducts screening for all Cosmetic applications;
Codes all cosmetics application;
Prepares matrix for submission to Research, Record & data Unit.

medical device Unit

Receives all applications for listing of Medical Devices;
Performs checklist for the listing of Medical Devices;
Conducts screening for all Medical Devices;
Codes all Medical Devices application;
Prepares matrix for submission to Research, Record & data Unit.

research and data Unit

Conducts research on all Pharmaceutical manufacturing Companies;
Provides information on the manufacturing details of each company (Tablets, Capsules, small volume parenteral ( Injectable, Infusion , Syrups, Suspensions etc.) ointments and Creams;
Prepares Import Permit & Clearances;
Conducts full research on the products characteristics (Product’s Name, Registration Number, Strength, Pack Size, Volume, Color of Packaging and Manufacturer;
Designs matrixes for all pharmaceuticals.

record and development Unit

Records all pharmaceuticals into the various Matrixes designed by the Research & Data Unit;
Prepares the certificate for marketing authorization;
Prepares products registration list;
Updates website periodically for all pharmaceuticals.

Narcotic & Psychotropic Unit

Receives applications for import authorization;
Screens applications according to the Narcotic Act;
Prepares authorization in line with the MOH guidelines for importation of Narcotic & Psychotropic;
Collaborates with MOH for periodic monitoring.