Sierra Leone
Official Name: Republic of Sierra Leone
Capital: Freetown
Independence Day: 27 April 1961
Currency: Leone (SLL)
Indicators
Regulatory Framework
The Pharmacy Board of Sierra Leone (PBSL) regulates medicines in Sierra Leone. It aims at implementing appropriate and workable regulatory of the practice of pharmacy by professionals, and of safety, efficacy and quality of all drugs, medical devices, cosmetics and nutritional agents (collectively named “products”) locally manufactured, imported, exported, distributed, sold or used to ensure the protection of the public health as envisaged by the Pharmacy and Drugs Act, 2001 ().The PBSL performs the following regulatory functions: drug evaluation and registration, licensing, import control, market and quality control, pharmacovigilance, clinical trials, and drug promotion and advertising.
Drug Evaluation and Registration
The Drug evaluation and registration department consists of three divisions, namely: pre-market evaluation, marketing authorization and post market evaluation. The following are the functions of the registration department:
• Receipt and processing of applications for product registration.
• Submission of product samples to the Quality Control Lab for Quality Analysis.
• Receipt of quality control results for product samples sent to the quality Control Lab
• Evaluation of dossiers for product registration.
• Receipt and processing of applications for Product Advertisement.
• Issuance of Market Authorization (Certificate) for products approved for marketing in Sierra Leone.
• Rejection of applications for products that do not comply with Board’s requirement for product registration.
• Compile a list of registered and pending products.
• Compile a list of pharmaceutical companies that have paid group fees and those that are yet to pay.
Application forms and guidelines for registration of a new drug, re-registration of a drug, and the registration of a variation of a drug can be found on the Pharmacy Board’s website. The Pharmacy Board has a Memorandum of Understanding with the Food and Drugs Authority of Ghana for the recognition of registration of medicines done in Ghana.
• Receipt and processing of applications for product registration.
• Submission of product samples to the Quality Control Lab for Quality Analysis.
• Receipt of quality control results for product samples sent to the quality Control Lab
• Evaluation of dossiers for product registration.
• Receipt and processing of applications for Product Advertisement.
• Issuance of Market Authorization (Certificate) for products approved for marketing in Sierra Leone.
• Rejection of applications for products that do not comply with Board’s requirement for product registration.
• Compile a list of registered and pending products.
• Compile a list of pharmaceutical companies that have paid group fees and those that are yet to pay.
Application forms and guidelines for registration of a new drug, re-registration of a drug, and the registration of a variation of a drug can be found on the Pharmacy Board’s website. The Pharmacy Board has a Memorandum of Understanding with the Food and Drugs Authority of Ghana for the recognition of registration of medicines done in Ghana.
Inspection
The PBSL has a Distribution Chain Inspection Department and a Factory Inspectorate. The functions of the Factory Inspectorate are not detailed on the website but the PBSL inspects local manufacturers for GMP compliance (). The Distribution Chain Inspection Department is charged with these functions:
• The department is responsible for the inspection of Retail Pharmacies, Drugstores, Patents and Cosmetic outlets, and reports to the Board.
• Ensuring that pharmacies, drugstores, patents and cosmetics outlets practice and maintain Good Storage and Distribution Practices of pharmaceuticals as prescribed by the Board.
• Formulation of polices relating to the Good Storage and Distribution Practices
• Regular Inspection exercises of all pharmaceutical and cosmetics shops
• Conduct suitability assessments of all pharmaceutical outlets
• Coordinate with other departments in the Board in the registration of Pharmaceutical Outlets
• Outreach activities
• Conduct regular raids against drug peddlers
• Conduct closures of unlicensed and unregistered/illegal premises
• The department is responsible for the inspection of Retail Pharmacies, Drugstores, Patents and Cosmetic outlets, and reports to the Board.
• Ensuring that pharmacies, drugstores, patents and cosmetics outlets practice and maintain Good Storage and Distribution Practices of pharmaceuticals as prescribed by the Board.
• Formulation of polices relating to the Good Storage and Distribution Practices
• Regular Inspection exercises of all pharmaceutical and cosmetics shops
• Conduct suitability assessments of all pharmaceutical outlets
• Coordinate with other departments in the Board in the registration of Pharmaceutical Outlets
• Outreach activities
• Conduct regular raids against drug peddlers
• Conduct closures of unlicensed and unregistered/illegal premises
Licensing
There are legal provisions that require importers, wholesalers, distributors, pharmacists and local manufacturers to be licensed. There is also legislation that requires both domestic and international manufacturers to comply with GMP guidelines, and wholesalers and distributors to comply with Good Distribution Practices.
Import Control
Legal provisions exist requiring authorization to import medicines into the country. There are also legal provisions that authorize the sampling of imported medication for testing. The imported medicines are also to be inspected at the ports of entry.
Market and Quality Control
There is a national laboratory, which is a part of the NMRA, where medicine samples are tested. Government inspectors collect medicine samples for post-market surveillance. Samples are tested for the following reasons: For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities), quality monitoring in private sector (routine sampling in retail outlets), when there are complaints or problem reports; for product registration and public program products prior to acceptance and/or distribution.
Pharmacovigilance
The pharmacovigilance department has three units, namely: the public health unit, clinical trials unit and clinical practice unit. The functions of this department are:
• Communicate safety information to health practitioners and the general public through newsletters, the electronic and print media
• Distribute adverse drug reaction (ADR) forms to all health facilities nationwide
• Confirm receipt of ADR reports including Adverse event following immunization (AEFI) reports and give feedback to reporters, participating institutions and other key stakeholders
• Commit ADR reports to WHO – UMC Vigiflow database
• Evaluation of clinical data for registration of new products
• Collaboration with pharmaceutical manufacturers concerning the safety of marketed products
• Conduct hospital inspections
• Conduct Pharmacovigilance Inspections
SAHPRA uses Vigiflow software tool to report adverse drug reactions. There is a platform on the National Department of Health Website that allows health care professionals to report ADRs. The document is generated in pdf form. SAHPRA had an ADR Database created just for the authority. The only disadvantage was that when information had to be exported from the database to Vigiflow, some of the data gets trimmed and is lost.
• Communicate safety information to health practitioners and the general public through newsletters, the electronic and print media
• Distribute adverse drug reaction (ADR) forms to all health facilities nationwide
• Confirm receipt of ADR reports including Adverse event following immunization (AEFI) reports and give feedback to reporters, participating institutions and other key stakeholders
• Commit ADR reports to WHO – UMC Vigiflow database
• Evaluation of clinical data for registration of new products
• Collaboration with pharmaceutical manufacturers concerning the safety of marketed products
• Conduct hospital inspections
• Conduct Pharmacovigilance Inspections
SAHPRA uses Vigiflow software tool to report adverse drug reactions. There is a platform on the National Department of Health Website that allows health care professionals to report ADRs. The document is generated in pdf form. SAHPRA had an ADR Database created just for the authority. The only disadvantage was that when information had to be exported from the database to Vigiflow, some of the data gets trimmed and is lost.
Clinical Trials
Before the commencement of a clinical trial, the sponsor and principal investigator are required to receive authorization from the PBSL. The sponsor and the PI are to ensure that the protocol satisfies the protocol checklist requirements. The PBSL’s review and approval of a clinical trial application is dependent upon obtaining Ethics Committee’s approval.
Information Management System
The Pharmacy Board had a computerized information management system but only importation and registration information are computerized.
Regulation Authority
Somalia does not have a working pharmaceutical regulatory authority and neither does it have recorded data on the status of healthcare in the country. No regulations concerning pharmaceuticals have been published recently or are easily available through online access for parties with interest. Much of the variability in the quality and range of health services available is due to Somalia’s unstable political situation. The three zonal Ministries of Health (Ministry of Health of the Transitional Federal Government, Ministry of Health and Labour of Somaliland, and the Ministry of Health of Puntland) operate with varying (and overall limited) levels of influence over domestic operations. Bilateral donors and international NGOs are the most significant contributors to the formal health care system, but aid is uncoordinated, without common long-term agendas.
Imports
Somalia is critical for the pharmaceutical trade because its duty-free conditions have made it a major import channel for the Horn of Africa (Kenya and Ethiopia). There are linkages between the pharmaceutical market in Ethiopia and Somalia, but little is known about the routes which are taken or the amount of goods that cross the border. Drug supply routes are the least investigated segment of the health system in Somalia although a study did find that most medicines in the central Bakaarha market in Mogadishu came from Pakistan and India.
Information Management System
Somalia has a MoH website: https://moh.gov.so/en/ through which it shares information pertaining to the pharmaceutical activities happening in the country. The site has no link to IGAD’s portal, a community to which it is part. However, as part of IGAD, the country does get benefits from the medicine regulation harmonization from the medicine regulation policies that the community has put in place.
Regulatory Authority
The regulatory functions of South Africa are Registration, Quality Control, Inspections, Licensing, Pharmacovigilance, Clinical Trials, and Market Surveillance. SAHPRA is currently using a new and re-engineered system of medicine regulation. SAHPRA conducts GMP inspections, inspection of Clinical Trial Facilities, and inspection of Distribution channels. The Authority licenses facilities and currently cannabis for medicinal purposes.
The Quality Control department investigates any complaint that is reported and tests samples in the quality control labs. The Quality Control department also handles the testing of vaccines. Vaccines need to be tested before they are administered to patients.
The Quality Control department investigates any complaint that is reported and tests samples in the quality control labs. The Quality Control department also handles the testing of vaccines. Vaccines need to be tested before they are administered to patients.
Medicine Registration
To register a medicine, an applicant has to submit a dossier to the regulatory authority. They need to compile the dossiers in line with the requirements for registration. The dossiers are submitted via CTD or E-CTD format. Dossiers can be submitted on a flash drive or CD which and then uploaded unto SAHPRA’s system. After submission, there has to be a business validation and a technical validation of the application.
• The Business validation is to ensure that the dossier is complete
• The Technical validation ensures that everything in the dossier is compliant with the guidelines.
There are two different reports that will be generated from the validation processes. The documents are then handed over to reviewers. Reviewers assess the dossier. There are different reviewers for each required CTD module of the dossiers. The Inspectorate handles issues of Good Manufacturing Practices compliance
• The Business validation is to ensure that the dossier is complete
• The Technical validation ensures that everything in the dossier is compliant with the guidelines.
There are two different reports that will be generated from the validation processes. The documents are then handed over to reviewers. Reviewers assess the dossier. There are different reviewers for each required CTD module of the dossiers. The Inspectorate handles issues of Good Manufacturing Practices compliance
Inspection for Registration
The Authority checks for illegal products on the market and counterfeits. SAHPRA is a member of a committee for regulatory authorities to share information on safety alerts and recalls, then communicate information to the public, warning them of safety issues relating to medicines.
If the site has not been inspected before, the authority will draw up an inspection plan. They review all documentation and guidelines before going to the site. The applicant must also be notified with the date of inspection. The inspectors enter data and comments electronically on site. Have a meeting to discuss observations made. Then an inspection report is drafted. There is an in-house peer review system that reviews all documentation, which will be used to peer-review the report.
This report is then sent to the applicant to check for deficiencies. The applicant is supposed to respond with the necessary corrections, which will be evaluated again by the inspectors. Then another inspection report is generated and sent to be approved. If the application proves to be GMP positive, the GMP database is updated with the information. The GMP reports are then compiled for registration.
For a medicine to qualify for registration, it needs to be GMP certified, have an approved name and schedule, have a positive quality report and a Patient Information Leaflet.
SAHPRA is a member of Pharmaceutical International Corporate Scheme (PICS). If a site has been inspected by PICS member, SAHPRA conducts a desk review.
If the site has not been inspected before, the authority will draw up an inspection plan. They review all documentation and guidelines before going to the site. The applicant must also be notified with the date of inspection. The inspectors enter data and comments electronically on site. Have a meeting to discuss observations made. Then an inspection report is drafted. There is an in-house peer review system that reviews all documentation, which will be used to peer-review the report.
This report is then sent to the applicant to check for deficiencies. The applicant is supposed to respond with the necessary corrections, which will be evaluated again by the inspectors. Then another inspection report is generated and sent to be approved. If the application proves to be GMP positive, the GMP database is updated with the information. The GMP reports are then compiled for registration.
For a medicine to qualify for registration, it needs to be GMP certified, have an approved name and schedule, have a positive quality report and a Patient Information Leaflet.
SAHPRA is a member of Pharmaceutical International Corporate Scheme (PICS). If a site has been inspected by PICS member, SAHPRA conducts a desk review.
Clinical Trials
For clinical trials to be conducted, an applicant has to submit a clinical trial application form. The applicant needs the form, the protocol and supporting documents. This will be sent to the Clinical Trial unit for administrative and technical screening. This is to ensure completeness of the document. The document can be categorized under the following depending on the severity of issues with the document:
• Category 1A: The document is approved out rightly. No issues were raised
• Category 1B: The document checks all the boxes but needs approval from the ethics committee.
• Category 2A: There are administrative issues with the document.
• Category 2B: The issues in the application has to be evaluated against the applicant’s responses by the original reviewer. It does not need to go to the peer review committee.
• Category 3: The are major deficiencies in the document. After responses have been evaluated by the initial reviewer it needs to be reviewed again by a team of experts.
• Category 4: This is for applications of a new molecule that need the expertise of an individual outside the technical advisory team.
• Category 5: The document has serious deficiencies and may have to be resubmitted.
SAHPRA has a software for clinical trials named the Clinical Trials database. However, it was not effective since it could not handle large documents and they are hoping to get a better system for this regulatory function.
• Category 1A: The document is approved out rightly. No issues were raised
• Category 1B: The document checks all the boxes but needs approval from the ethics committee.
• Category 2A: There are administrative issues with the document.
• Category 2B: The issues in the application has to be evaluated against the applicant’s responses by the original reviewer. It does not need to go to the peer review committee.
• Category 3: The are major deficiencies in the document. After responses have been evaluated by the initial reviewer it needs to be reviewed again by a team of experts.
• Category 4: This is for applications of a new molecule that need the expertise of an individual outside the technical advisory team.
• Category 5: The document has serious deficiencies and may have to be resubmitted.
SAHPRA has a software for clinical trials named the Clinical Trials database. However, it was not effective since it could not handle large documents and they are hoping to get a better system for this regulatory function.