DRUG REGISTRATION AND INSPECTORATE DIVISION

The Division's mandate as derived from Part 6, 7 & 8 of the Public Health Act 2012, Act 851, is to protect public health and safety by ensuring the availability of safe, efficacious and quality allopathic medicines, veterinary medicines, vaccines, biological products, tobacco & tobacco products, herbal medicines, homoeopathic medicines, food supplements, medical devices, cosmetics and household chemical substances on the Ghanaian market. The key regulatory functions of the HPTD include regulation of clinical trials, product registration and
1.Clinical Trail Department
2.Drug and Nutraceuticals Department
3.Herbal and Homeopathic Medicines Department
4.Vaccines and Biological Products Department
5.Tobacco and Substances of Abuse Department
6.Medical Devices Department
7.Cosmetics and Household Chemicals Substances Department
8.Safety Monitoring Department

CLINICAL TRIALS DEPARTMENT
The Clinical Trials Department of the FDA is responsible for authorization and monitoring of clinical trials as required by Part 8 of the Public Health Act, 2012 Act 851. The Department is designated as a Regional Centre of Regulatory Excellence (RCORE) in clinical trial regulation in Africa, and has trained over 50 African regulators in clinical trial regulation as a result of this. 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.
The legal mandate of the FDA as per Part 8 of the Public Health Act 2012, Act 851 is to authorize and monitor clinical trials through;
-Development of appropriate guidelines for the conduct of clinical trials
-Issuance of Clinical Trial (CT) Certificates (permit for conducting clinical trials)
-Reviewing of all reports from trial sites
-Conducting Good Clinical Practice (GCP) inspections at trials sites to ensure compliance of trials to international best practices and local regulatory requirements
-Investigating the conduct of clinical trial
-Suspension or stopping clinical trials (if necessary)

Currently the Department has two (2) units with the following activities:
Clinical Trials Authorization Unit
-Receiving of Clinical Trial Applications (CTAs)
-Planning, scheduling and coordinating of CTA evaluation meetings
-Evaluation of CTAs and amendments
-Correspondence of evaluation on CTAs and amendments to applicants
-Processing of permits for Investigational Products
-Acknowledgement of general correspondences
-Coordinating and planning of Technical Advisory Committee (TAC) meetings
-Developing and updating relevant information on the FDA website

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

Operational Guidelines and Tools

The Clinical Trials Department in carrying out its mandate and daily activities has developed the underlisted tools. These are reviewed and updated periodically when necessary to ensure they continue to be in line with international best practices.
The FDA has also adopted for use, the Africa Vaccine Regulatory Forum (AVAREF) forms, checklists and guidelines on Clinical Trials.

1.Four (4) guidelines:

-Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in Ghana
-Guidelines for Good Clinical Practice in Ghana
-Guidelines for Conduct of Clinical Trials in Pediatric Population
-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 on-going trials quarterly)
5.Clinical Trial Close-out Report Form (submitted by trial when trial ends and close-out activities have been carried out)
6.Clinical Trial Report Form (format used in reporting final trial reports at the end of trials, that is ICH E3) Other administrative tools include;

-GCP Inspectors Notes
-GCP Observation Sheet
-GCP Inspection Checklist
-In-house Evaluation Forms

Achievements
-Designation of the FDA, Clinical Trials Department as a Regional Centre of Regulatory Excellence (RCORE) in clinical trials by AUDA-NEPAD since 2014. The FDA as an RCORE in clinical trials has trained 54 regulators in Sub-Saharan Africa in order to enhance capacity of regulators in the field of clinical trials.
-Member of African Vaccine Regulatory Forum (AVAREF) since 2006 till date. This has contributed to harmonization of regulatory procedures across Africa.
-First country to participate in registration of clinical trials on AVAREF adopted site Pan African Clinical Trials Registry (PACTR).
-Representation on the Ministry Health's Ethics Committee (the largest for public health trials).
-Non-EU member of European Medicines Agency (EMA) Good Clinical Practice (GCP) Inspectors' Working Group.

The Technical Advisory Committee on Clinical Trials
In fulfillment of the requirements of the law, the Food and Drugs Authority has a 12-member Technical Advisory Committee, whose objective is to provide the FDA with ongoing and timely medical and scientific advice on current and emerging issues related to clinical trials. Current members of the Committee with their respective expertise are as follows:

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

DRUG AND NUTRACEUTICALS DEPARTMENT (DNC)The Mandate of the Drug and Nutraceuticals 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 allopathic medicines (human and veterinary) intended for export and/or sale on the Ghanaian market.
Operational Activities
The operational activities of the Department are as follows:
1.Processing approvals for new, renewal and variation applications.
2.Coordinating dossier evaluation and product registration meetings
3.Maintaining the Drug Register
4.Correspondence with applicants
5.Issuance of registration certificates
6.Revocation of registration certificates
7.Drafting and reviewing of guidelines and codes of practice
8.Stakeholders engagement on matters relating to registration of pharmaceutical products.

The Department has three operational units. These are:
-The Local Medicines Registration Unit
-The Fast-Track/ Low Risk Registration Unit
-The Foreign High-Risk Registration Unit.

Timelines for processing applications Variations
Notifications (Do and Tell);
1.Immediate notification -1-month annual notification -12 months
2.Minor Variations (Do, Tell and Wait) - 3 months
3.Major Variations (Requires formal approval) - 6 months Fresh Applications
4.High Risk and Low Risk Applications - 6 months (180 days)
5.Fast Track Applications - 3 months (90 days)
6.Renewal Applications - 3 months (90 days)

International Collaborations

The Department works closely with the West Africa Health Organization (WAHO) Joint Medicine Evaluation Harmonization Process. FDA is the lead coordinating country for West Africa Medicines Regulatory Harmonization (WA-MRH) Project. The Drug And Nutraceuticals Department (DNC) therefore receives and submits complete applications to the WA-MRH Joint Assessment Process; serves as liaison between the Joint Assessors and applicants, exchanging the relevant information and provides the final notification of acceptance or rejection to applicants.


Regional Center of Regulatory Excellence (RCORE) for Medicine Evaluation Registration in Africa
The 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 Drug Registration in May 2014.
As an RCORE, the FDA in collaboration with the School of Public Health, University of Ghana, seeks to build capacity in dossier assessment 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 African citizens.

HERBAL AND HOMEOPATHIC MEDICINES DEPARTMENT (HHM)

The Mandate of the Herbal and Homeopathic Medicines 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 Herbal Medicinal Products
*Section 119 Cancellation or Suspension of Registration
*Section 124 Registration of Homeopathic Drug
*Section 128 Herbal Medicinal Products and Homeopathic Drug Register
*Section 147 (1) - (3) Regulations
*Section 148 (1)-(4) Guidelines and Codes of Practice.


Scope of Mandate

The Department processes and grants market authorization for herbal and homeopathic medicines intended for export and/or sale on the Ghanaian Market.

Operational Activities
The operational activities of the Department are as follows:
1.Processing and approvals for new, renewal and variation applications.
2.Coordinating dossier evaluation and product registration meetings
3.Maintaining the herbal and homeopathic medicines register
4.Correspondence with applicants
5.Issuance of registration certificates
6.Revocation of registration certificates
7.Drafting and review of guidelines and codes of practice
8.Stakeholders engagement on matters relating to registration of pharmaceutical products.

The Department has two operational units. They are:

-The Herbal and Homeopathic Medicines Unit
-The Food Supplements of Herbal origin Unit

VACCINE AND BIOLOGICAL PRODUCTS DEPARTMENT (VBPD)
The mandate of the Vaccines and Biological Products Department (VBPD) is to apply appropriate regulatory instruments, including guidelines and policies to ensure that only Quality, Safe and Efficacious Vaccines and Biological Products are approved to be imported and used in Ghana.
VBPD manages and coordinates the evaluation processes, which precedes the granting of Marketing Authorization (MA). In addition, VBPD conducts audits of Blood Facilities towards their licensure and listing of Blood and Blood Components (BBC) prepared by the facility to ensure blood safety nationwide.
Currently, the Department operates with three distinct Units. These are:
-Vaccine and Advance Therapy Medicinal Products Unit
-Biotechnology-Derived Medicinal Products Unit
-Blood and Plasma-Derived Medicinal Products Unit

Scope of regulated products includes:
1.Vaccines and Advance Therapy Medicinal Products (ATMPs) (Cellular and Gene Therapy Products)
2.Biotechnology-Derived Medicinal Proteins (Innovator/ Biosimilars or Follow-on Biologics or Subsequent Entry Biologics)
3.Blood, Blood Components (BBC)
4.Plasma-Derived Medicinal Products
5.Low Molecular Weight Heparins

TOBACCO AND SUBSTANCES OF ABUSE DEPARTMENT (TSAD)
The mandate of the Tobacco and Substance of Abuse Department is defined by Part 7-Section 126 and Part 6 of the Public Health Act, 2012, Act 851 and the Tobacco Control Regulations, 2016 (LI. 2247).
Scope of Mandate
Department operations cover the utilisation of narcotic drugs, psychotropic substances and chemical precursors for medical, scientific and research purposes only, whilst preventing its abuse and diversion from licit to illicit use. The Department is also responsible for the regulation of tobacco and tobacco products to ensure reduction and subsequent prevention of tobacco use through effective implementation of the tobacco control measures.
Operational Activities
The operational activities for the department are as follows:
1.Public education on the abuse of substances and tobacco and tobacco products.
2.Development of information and educational communication materials to promote and create awareness associated with tobacco use and substance abuse.
3.Allocation of controlled substances to importers.
4.Issuance of permits for controlled substances, raw material and finished products.
5.Monitoring of controlled substances to prevent its diversion to illicit use.
6.Correspondences with the International Narcotics Control Board.
7.Stakeholder's engagement activities including the celebration of international days such as World No Tobacco Day, International Drug Day.
8.Registration and issuance of certificates for tobacco and tobacco products.
9.Maintain the tobacco register.
10.Registration of importers of tobacco and tobacco products.
11.Monitoring compliance to tobacco control regulations.
12.Dossier evaluation.
13.Drafting and reviewing of guidelines.

The Department has two operational units. They are:
-The Narcotics Unit
-The Tobacco Unit.
Notable Achievements of the Department
1. Enforcement of the provisions of the international conventions on psychotropic and narcotic substances leading to the restriction of use of narcotics and psychotropic substances for only research and medicinal purposes.
2. Outright ban of cough syrups containing codeine nationwide through the Executive Instrument named as E.I.167 - 'Instructions for the restriction of importation, manufacture and registration of codeine-containing cough syrups instrument, 2018'.
3. Restricted control on tramadol through the Executive Instrument named E.I.168 -'Instructions for the control of the importation, manufacture and sale of tramadol and tramadol containing products instrument, 2018'
4. The implementation of the Pictorial Health Warnings (PHW) on Tobacco and tobacco product packages which took effect on the 1st November, 2018. All imported registered tobacco products now have the PHWs imprinted on their packages.
5. Ratification of the Protocol for the Elimination of illicit Trade in Tobacco Products on April 11th, 2019 which aims at eliminating all forms of unlawful trade in tobacco products, in accordance with the terms of Article 15 of the WHO FCTC, secure the supply chain of tobacco products and protect people across the globe from the risks of tobacco use and exposure to tobacco smoke.

MEDICAL DEVICES DEPARTMENT (MDD)
The mandate of the Medical Devices Department is defined by the following Sections of Part 7 of the Public Health Act, 2012, Act 851:
*Section 118 Registration Medical Devices
*Section 119 Cancellation or Suspension of Registration
*Section 147 (1) - (3) Regulations
*Part 7 Section 148 (1)-(4) Guidelines and Codes of Practice.

Scope of Mandate
The Department processes and grants market authorization for medical devices intended for export and/or sale on the Ghanaian market.
Operational Activities
The operational activities of the Department are as follows:
1.Processing approvals for new, renewal and variation applications.
2.Participation in product registration meetings
3.Dossier evaluation
4.Maintain the medical devices register
5.Correspondence with applicants
6.Issuance of registration certificates
7.Revocation of registration certificates
8.Coordination of TAC Meetings on medical devices
9.Coordination of site testing of medical devices
10.Listing of importers of medical devices.
11.Drafting and reviewing of guidelines and codes of practice
12.Stakeholders engagement on matters relating to registration of Medical Devices
13.Collaboration with Ghana Standards Authority (GSA) for the development of standards for medical devices
14.Collaboration with Nuclear Regulatory Authority for the regulation of radiation emitting medical devices

The Department has two operational units. They are:
-The Evaluation and Registration of Low Risk Medical Devices Unit
-The Evaluation and Registration of High-Risk Medical Devices Unit

COSMETICS AND HOUSEHOLD CHEMICAL SUBSTANCES DEPARTMENT (CHCD)
The mandate of the Cosmetics and Household Chemical Substances Department is defined by the following Sections of Part 7 of the Public Health Act, 2012, Act 851:
*Section 118 Registration of Cosmetics and Household Chemical Substances
*Section 119 Cancellation or Suspension of Registration
*Section 147 (1) - (3) Regulations
*Part 7 Section 148 (1)-(4) Guidelines and Codes of Practice.
Scope of Mandate
The Department processes and grants market authorisation for cosmetics and household chemical substances intended for export and/or sale on the Ghanaian market.
Operational Activities

The operational activities for the Department are as follows:
1.Processing approvals for new, renewal and variation applications.
2.Participation in product registration meetings
3.Maintain the cosmetics and household chemical substances registers
4.Correspondence with applicants
5.Issuance of registration certificates
6.Revocation of registration certificates
7.Registration of importers of cosmetics and household chemical substances.
8.Drafting and review of guidelines and codes of practice

The Department has two operational units. They are:
-The Cosmetics Unit
-The Household Chemical Substances Unit

SAFETY MONITORING DEPARTMENT
The mandate of the Safety Monitoring Department is defined in Section 125 of the Public Health Act, 2012. The Department 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.
The safety monitoring system in Ghana is decentralized to ensure efficient and effective coordination of pharmacovigilance activities in all 16 regions.
There are Institutional Contact Persons (ICPs) at the healthcare facilities with responsibility for safety monitoring of drugs, vaccines and other health products. The ICPs act as the point of contact for the FDA with regard to the safety monitoring of products within the health facilities.
Functions
The SMD has two Units. They are:
-The Vigilance Unit
-The Risk Management Unit

Vigilance Unit
1.Ensure pharmaceutical industries comply with the safety monitoring requirements
2.Carry out Good Pharmacovigilance Practice Inspections
3.Liaise with Public Health Programmes 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 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 (Safety Watch System).
3.Receive and process individual Case Safety Reports
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/Periodic Benefit-Risk Evaluation Reports and Safety variations for regulated products submitted to the Authority.
7.Follow up on the implementation of risk minimization activities
8.Ensure the Department's commitment to the FDA's quality management system.
Achievements
-The Safety Monitoring Department attained Maturity Level 4 regulatory function by the World Health Organization; the highest level any regulatory function can attain. This signifies 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.
-In 2016, the FDA embarked on an initiative to empower the consumers and patients to report safety issues of regulated products to the FDA through Community Pharmacies designated as Patient Safety Centers.
-The Med Safety App was introduced in 2019 as an additional reporting tool to ensure real time reporting of safety issues for medicines, vaccines and other related health products.

The Safety Monitoring Department has several years of experience in monitoring the safety of vaccines. The Department 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 and serves as a training centre for regulators from other African Countries
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 (Safety Watch 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:
-USAID (United States Agency for International Development) through the Strengthening Health Outcomes through the Private Sector
-West African Health Organization
-African Collaborating Centre for Pharmacovigilance
Public Health Programmes (PHPs)
PHPs involve the administration of medicines to large populations. Pharmacovigilance plays a role in the successful implementation of PHPs. In view of this, the SMD coordinates pharmacovigilance activities in collaboration with the underlisted Public Health Programmes
Expanded Programme on Immunization (EPI): Coordinates adverse event 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 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 anti-retroviral 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.

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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