Safety Monitoring Department

The Safety Monitoring Department of the Food and Drugs Authority hosts the National Pharmacovigilance Centre. The Centre joined the WHO Programme for International Drug Monitoring (PIDM) in November 2001 as the 65th member of the Programme.
Staff of the Department are dedicated scientists with background in pharmacy, chemistry, biological science with most having Masters' Degrees and several years's experience in the area of pharmacovigilance with some of them involved in activities by the World Health Organization to promote patient safety in sub-Saharan Africa.

In 2020, the Safety Monitoring Department was adjudged Maturity Level 4 Regulatory function by the World Health Organization. This means that the safety monitoring function of the FDA is at an advanced level of performance with continuous improvement needed in monitoring the safety of medicines, vaccines and other health products. Maturity Level 4 is the highest level any regulatory function can attain.

The safety monitoring system is decentralized with FDA's regional offices involved in coordination pharmacovigilance in all the 16 regions. There are also Institutional Contact Persons at the healthcare facilities with responsibility for safety monitoring of drugs, vaccines and other health products. In 2016, the FDA also embarked on an initiative to empower the general public to report safety issues of regulated products to the FDA.

The Safety Monitoring Department has had several years of experience in monitoring the safety of vaccines. The Department has effectively coordinated the introduction of new vaccines including the pneumococcal/rotavirus vaccines, measles rubella and the ongoing Malaria Vaccine Pilot Implementation Programme which has gone on for close to two years without major safety concerns.

The Safety Monitoring Department is also a Regional Centre of Regulatory Excellence (RCORE). The Department serves as a training centre for regulators from other African Countries.
The Safety Monitoring Department has two functional Units namely, the Vigilance Unit and Risk Management Unit.

Functions
The SMD has two Units, the Risk Management and Vigilance Units. The broad objectives of the Department are safety monitoring of products, awareness creation amongst patients, consumers and healthcare professionals on the need to report adverse events.

Vigilance Unit
1. Ensure pharmaceutical industries comply with the requirements in Section 125, Subsection 1 and 2 of the Public Health 2012, Act, 851 and applicable guidelines.
2. Carry out Good Pharmacovigilance Practice (GVP) Inspections
3. Liaise with Public Health Programmes (PHPs) to ensure pharmacovigilance becomes an integral component of these programmes
4. Create awareness on pharmacovigilance for healthcare professionals and to the general public.
5. Organize training programmes for stakeholders
6. Produce Drug Safety Newsletter (DrugLens) and Patient Safety Newsletter.
7. Produce Information Education and Communication (IEC) materials to promote safety monitoring of products.

Risk Management Unit
1. Ensure availability of Reporting Forms at user points and functioning of the electronic platforms for reporting adverse events.
2. Maintain the FDA's Safety Database (SafetyWatch System).
3. Receive and Process of Individual Case Safety Reports (ICSRs)
4. Coordinate Technical Advisory Committees Meetings
5. Communicate alerts and safety issues to stakeholders
6. Review safety information including but not limited to Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSUR) /Periodic Benefit-Risk Evaluation Reports (PBRER) and Safety variations for regulated products submitted to the FDA.
7. Follow up on the implementation of Risk minimization activities
8. Ensure the Department's commitment to the FDA's quality management system.

Collaborating Agencies and Stakeholders

*Medicines and Healthcare Regulatory Agency (MHRA): Technical assistance with the development of consumer/patient reporting system for reporting safety issues and E2B compliance database (SafetyWatch System) for safety data management.
*World Health Organization/ Uppsala Monitoring Center: Technical assistance in the form of training.
*Ghana Health Service (GHS): Monitoring and evaluation of Pharmacovigilance performance within healthcare facilities using the pharmacovigilance assessment tool.

Other agencies the department collaborates with are:
*United States Agency for International Development (USAID) through the SHOPs-Strengthening Health Outcomes through the Private Sector)
*West African Health Organization (WAHO)
*African Collaborating Centre for Pharmacovigilance (ACC)

Public Health Programmes (PHPs)
PHPs involves the administration of medicines to large populations. Pharmacovigilance in PHPs plays a role in the successful implementation of PHPs. In view of this, the SMD coordinates pharmacovigilance activities in collaboration with the under-listed Public Health Programmes.

*Expanded Programme on Immunization (EPI): Coordinates adverse events following immunization (AEFI) monitoring during vaccination campaigns and routine immunization programmes. The Department ensures that the reports are evaluated by the Technical Advisory Committee on Safety of Vaccines and Biological Provides (TAC-VBP) and feedback is provided to the EPI and other stakeholders.
*National Malaria Control Programme (NMCP): Coordinates the monitoring of adverse events in the Seasonal Malaria Chemoprevention and other anti-malaria campaigns.
*National Tuberculosis Control Programme (NTBCP): coordinates the monitoring of adverse events in patients on anti-tuberculosis medicines.
*National AIDS Control Programme: coordinates the monitoring of adverse events in patients receiving antiretroviral therapy.
*Neglected Tropical Diseases Control Programme: coordinates the monitoring of adverse events in the patients receiving therapy for neglected tropical diseases such as Lymphatic Filariasis, Onchocerciasis, Trachoma, Schistosomiasis, Soil-transmitted helminthiasis, Buruli ulcer, Yaws, Leprosy, Guinea worm, Human African Trypanosomiasis (HAT), Cutaneous Leishmaniasis and Rabies.

CLINICAL TRIALS DEPARTMENT

Legal Mandate
The FDA was formally mandated by the Food and Drugs Law of 1992, PNDCL 305B and its amendment, Act 523. In 2012, this law was reviewed and the Public Health Act (PHA) 2012, Act 851 was passed as a result of the review and the mandate of the FDA was to increase the scope and enhance public health and safety. The part 8, Sections 150 - 166 of the PHA 2012, Act 851mandates the FDA to regulate Clinical Trials.

The legal mandate of the FDA as per the PHA is to authorize and monitor clinical trials through;

*Development of appropriate guidelines for the conduct of clinical trials
*Issuance of CT Certificates (permit for conducting clinical trials)
*Reviewing of all reports from trial sites
*Conducting Good Clinical Practice (GCP) inspections at trial sites to ensure compliance of trials to international best practices and local regulatory requirements.
*Investigating the conduct of the clinical trial
*Suspension or stopping clinical trials (if necessary)

The Technical Advisory Committee on Clinical Trials
To satisfy the requirements of the law, a 12-member experts committee (an Advisory Committee on Clinical Trials), whose objective is to provide the FDA with ongoing and timely medical and scientific advice on current and emerging issues related to clinical trials, has been established. Current members of the Committee with their respective expertise are as follows:

Epidemiologist
Clinical Pharmacologist
Toxicologist, Pharmacologist
Biostatistician
Pediatrician
Social Scientist
Surgical Specialist
Clinical Pathologist
Family Medicine Specialist (Geriatrician)
Internal Medicine Practitioner
Clinical Pharmacist
Medical Herbalist
Clinical Trials Department

The Clinical Trials Department of the FDA is responsible for the authorization and monitoring of clinical trials as required by the Public Health Act. The Department aims to implement the appropriate and modern regulatory measures to achieve the highest standard for design, conduct, recording and reporting of clinical trials in Ghana such that data and results from cosmetics, household chemical substances and medical devices that are locally manufactured, imported, exported, distributed, sold or used.
This will ensure the protection of the consumer as envisaged by the laws regulating food and drugs in force in Ghana. General Programmes and Activities of the Department include among others;
1. Clinical Trial Application Review
2. GCP Inspections at trial sites
3. GCP Training for investigators and study team (general or customized)
4. Acting as the Secretariat to the Technical Advisory Committee on Clinical Trials
5. Review of importation permits for investigational products used in the conduct of clinical trials
6. Review of all reports for clinical trials (safety reports, quarterly reports, close-out reports, serious adverse event reports and final clinical trial reports)
7. Pre-submission/client service meetings to discuss issues related to Applications or any related issues regarding the conduct of clinical trials in Ghana.
8. Stakeholder engagement activities including seminars for institutions and professional bodies.
Currently, the Department has two (2) units with the following activities as follows:
a)Clinical Trials Authorization Unit
1. Receiving Clinical Trial Applications (CTAs)
2. Planning, scheduling and coordinating CTA evaluation meetings
3. Evaluation of CTAs and amendments
4. Correspondence of evaluation on CTAs and amendments to applicants
5. Processing of permits for Investigational Products
6. Acknowledgement of general correspondences
7. Coordinating and planning of Technical Advisory Committee (TAC) meetings
8. Developing and updating relevant information on the FDA website

b)Clinical Trials Compliance Unit
1. Update and maintenance of data on approved clinical trials
2. Receipt, evaluation and acknowledgment of Serious Adverse Event (SAE) reports
3. Processing SAEs for Technical Advisory Committee(TAC) meetings
4. Planning and coordinating GCP inspections for ongoing studies
5. Conducting GCP inspections at trial sites of ongoing studies
6. Organizing Good Clinical Practice training for Research Institutions
7. Coordinating training workshops (Internal & External)
8. Receipt and review clinical trial reports (quarterly and final)

The Clinical 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 such as ICH Guidelines. The FDA has also adopted for use, the AVAREF forms, checklists and guidelines for Clinical Trials.

1. Four (4) guidelines:
a. Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in Ghana
b. Guidelines for Good Clinical Practice in Ghana
c. Guidelines for Conduct of Clinical Trials in Paediatric Population
d. Guidelines for Conduct of Clinical Trials During Emergencies
2. Standard Operating Procedures (SOPs) for carrying out all departmental activities
3. Clinical Trial Application Form (completed and submitted together with other documents during a clinical trial application submission)
4. Quarterly Progress Report Form (trial sites report progress of approved ongoing trials quarterly)
5. Clinical Trial Close-out Report Form (submitted by trial when the trial ends and close-out activities have been carried out)
6. Clinical Trial Report Form (the format used in reporting final trial reports at the end of trials, that is ICH E3)

Other administrative tools include;

7. GCP Inspectors Notes
8. GCP Observation Sheet
9. GCP Inspection Checklist
10. In-house Evaluation Forms:

Achievements

*Development of appropriate guidelines for the conduct of clinical trials
*Issuance of CT Certificates (permit for conducting clinical trials)
*Reviewing of all reports from trial sites
*Conducting Good Clinical Practice (GCP) inspections at trial sites to ensure compliance of trials to international best practices and local regulatory requirements.
*Investigating the conduct of the clinical trial
*Suspension or stopping clinical trials (if necessary)

For further inquiries, kindly contact the Clinical Trials Department on +233244310297 or through drug.safety@fdaghana.gov.gh