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SAFETY MONITORING AND CLINICAL TRIALS DIVISION (SMCTD)

The Division’s mandate derived from Part 7 & 8 of the Public Health Act 2012, Act 851, is to protect public health by ensuring the availability of safe, efficacious and quality medical products on the Ghanaian market. The key regulatory functions of the Division include product and premises registration for biological products, clinical trial approval, and safety monitoring of medical products. The SMCTD achieves its mandate through the following Departments:

i. Safety Monitoring Department
ii. Clinical Trials Department
iii. Biological Products Department

SAFETY MONITORING DEPARTMENT (SMD)

The Mandate of the Safety Monitoring Department is defined by the following Sections of part 7 of the Public Health Act, 2012, Act 851;

• Section 125 (1)- (3) Safety monitoring
• Section 147 (1) - (3) Regulations
• Section 148 (1)-(4) Guidelines and Codes of Practice.
Scope of Mandate

The department undertakes post registration safety monitoring of medical products on the Ghanaian market.

Operational Activities

The operational activities of the department are as follows:

i. Maintain a register of local representatives for registered medicinal products.
ii. Review of safety reports
iii. Monitor the safety of regulated products
iv. Carryout pharmacovigilance Inspections
v. Organise Stakeholder engagements
vi. Participation in National Centres meetings
vii. Coordinate three (3) TAC Meetings – malaria vaccines, safety of medicines and safety of vaccines and biological products
viii. Prepare content for safety newsletters
ix. Drafting bills
x. Development and review of guidelines and codes of Practice

The Department has two operational units; the Risk Management Unit and Vigilance Unit.

CLINICAL TRIAL DEPARTMENT (CTD)

The Mandate of the Clinical Trial Department is defined by the following Sections of part 8 of the Public Health Act, 2012, Act 851;
• Section 150-153 Technical Advisory Committee
• Section 155-159 Clinical trials
• Section 160 Powers to stop or suspend clinical trials
• Section 161 Monitoring of clinical trials
• Section 162 Reports on clinical trials
• Section 163 Renewal of clinical trial certificate
• Section 165 Penalties
• Section 82 (f) Functions of the Authority

Sections of part 7 of the Public Health Act, 2012, Act 851

• Section 147 (1) - (3) Regulations
• Section 148 (1)-(4) Guidelines and Codes of Practice.
Scope of Mandate

The department undertakes approval and post approval monitoring of clinical trials for drugs, herbal medicinal products, cosmetics, medical devices or procedures.

Operational Activities

The operational activities of the department are as follows:

i. Clinical trials authorisation
ii. Audit trial sites in accordance to Good Clinical Practice (GCP) requirements
iii. Maintain database for approved clinical trials
iv. Organising TAC Meetings on Clinical Trials
v. Coordinating training workshops
vi. Organising GCP training for Research Institutions
vii. Clinical trials monitoring
viii. Review of serious adverse event and clinical trial reports
ix. Drafting bills
x. Development and review of guidelines and codes of Practice
The Department has two operational units; the Clinical Trials Authorisation Unit and Clinical Trials Compliance Unit.

1.2.3. INTERNATIONAL COLLABORATIONS

i. Regional Center of Regulatory Excellence (RCORE) for Medicine Evaluation Registration in Africa. FDA Ghana was designated by the New Partnership for African Development (NEPAD) and the African Regulatory Harmonization (AMRH) as a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials in May 2014. As an RCORE, the FDA builds capacity in good clinical trial practice within the sub-region and improve access to medicine through harmonization of regulatory requirements. This will ensure that quality, safe and efficacious medicines are available to patients.
ii. Member of African Vaccine Regulatory Forum (AVAREF) since 2006.
iii. Non-EU member of European Medicines Agency (EMA) Good Clinical Practice (GCP) Inspectors’ Working Group.
iv. First country to participate in registration of clinical trials on AVAREF adopted site Pan African Clinical Trials Registry (PACTR).

BIOLOGICAL PRODUCTS DEPARTMENT (BPD)

The Mandate of the Biological Products Department is defined by the following Sections of part 7 of the Public Health Act, 2012, Act 851;

• Section 117 Application for registration
• Section 118 Registration of drugs,
• Section 119 Cancellation or suspension of registration
• Section 147 (1) - (3) Regulations
• Section 148 (1)-(4) Guidelines and Codes of Practice.

Scope of Mandate

The department processes and grants market authorisation for biologics and related products including vaccines, blood and blood products, cellular therapy products, and gene therapy products (for human and veterinary use) intended for export and/or sale on the Ghanaian Market.

Operational Activities

The operational activities of the department are as follows:

i. Processing and approvals for new, renewal and variation applications.
ii. Participating in dossier evaluation and product registration meetings
iii. Maintain the biological products register
iv. Correspondence with applicants
v. Issuance of registration certificates
vi. Revocation of registration certificates
vii. Drafting of bills
viii. Drafting and review of guidelines and codes of practice
ix. Stakeholders engagement on matters relating to registration of biological products.

The Department has two operational units; the Clinical Trials Authorisation Unit and Clinical Trials Compliance Unit.

THE FDA MISSION

The FDA exists to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances, tobacco and the conduct of clinical trials in the country.

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