DRUG REGISTRATION AND INSPECTORATE DIVISION

1. DRUG REGISTRATION AND INSPECTORATE DIVISION (DRID)

The Division's mandate as derived from Part 6 & 7 of the Public Health Act 2012, Act 851, is to protect public health by ensuring the availability of safe, efficacious and quality allopathic medicines, veterinary medicines, herbal medicines, homoeopathic medicines and food supplements on the Ghanaian market. The key regulatory functions of the DRID include product registration, premises registration and post approval market surveillance for the aforementioned regulated products. The DRID achieves its mandate through the following Departments:

i. Drug Evaluation and Registration Department
ii. Herbal Medicines Department
iii. Drug Inspectorate Department
iv. Drug Market Surveillance Department
v. Tobacco and Substance of Abuse Department

DRUG EVALUATION AND REGISTRATION DEPARTMENT (DERD)

The Mandate of the Drug Evaluation and Registration 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:

i. Processing and approvals for new, renewal and variation applications.
ii. Coordinating dossier evaluation and product registration meetings
iii. Maintain the drug 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 pharmaceutical products.

The Department has three operational units; the Local Medicines Registration Unit, Fast-Trak/ Low Risk Registration Unit and Foreign High-Risk Registration Unit.

Timelines for processing applications Variations

i. Notifications (Do and tell);
Immediate notification -1 month

Annual notification -12 months
ii. Minor Variations (Do, tell and wait) - 3 months
iii. Major Variations (Requires formal approval) - 6 months Fresh Applications
i. High Risk and Low Risk Applications - 6 months (180 days)
ii. Fast Track Applications -3 months (90 days) Renewal Applications

i. 3 months (90 days)
INTERNATIONAL COLLABORATIONS

West Africa Health Organisation (WAHO) Joint Medicine Evaluation Harmonisation Process

FDA is the lead coordinating country for West Africa Medicines Regulatory Harmonization Project. The DERD therefore receives and submits complete applications to the WA-MRH Joint Assessment Process; serves as liaison between the Joint Assessors and the applicants, exchanging the relevant information and provides the final notification of (acceptance or rejection to the applicant.

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.

DRUG INSPECTORATE DEPARTMENT (DID)

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

Section 115 (1) Control of manufacturing
Section 130 Registration of premises
Section 131 Licences and permits
Section 147. (1) - (3) Regulations
Section 148. (1)-(4) Guidelines and Codes of Practice
Scope of Mandate

The department regulates manufacturing and storage facilities for allopathic, veterinary, homeopathic, and herbal medicines as well as food supplements.

Operational Activities

The operational activities for the department are as follows:

i. Audit of local and foreign manufacturing facilities for compliance to Good Manufacturing Practice requirements.

ii. Audit of local dry/cold storage facilities for compliance to Good Distribution Practice requirements.

iii. Issuance of license for approved manufacturing and storage facilities.

iv. Registration of importers of active pharmaceutical ingredients, finished pharmaceutical products, food supplements and herbal products.

v. Certification of qualified persons for manufacturing facilities. The Department has two operational units; the Warehouse Inspection Unit and Manufacturing Inspection Unit.

DRUG INDUSTRIAL SUPPORT DEPARTMENT (DISD)

The Mandate of the Drug Industrial Support Department is defined by the following Sections of part 7 of the Public Health Act, 2012, Act 851; Section 82 (f) Functions of the Authority

Scope of Mandate

The department provides support for manufacturing and storage facilities for allopathic, veterinary, homeopathic, herbal medicines, food supplements, cosmetics, medical devices and household chemical substances.

Operational Activities

The operational activities for the department are as follows:

i. Organise training programmes for local Industry GMP & GDP.
ii. Carry out gap assessments for local industry.
iii. Evaluation of block plans for manufacturing facilities.
iv. Evaluation of schematic drawings for equipment and utilities.
v. Provide technical support to local Industry.
vi. Develop programmes to build capacity of local industry to comply with national and/or international standards.
The Department has two operational units; the Premises Support Unit and Quality System Support Unit.

DRUG MARKET SURVEILLANCE DEPARTMENT

The Mandate of the Drug Market Surveillance Department is defined by the following Sections of part 7 of the Public Health Act, 2012, Act 851;

Sections 111 Prohibited sale of drugs, herbal medicinal products,
Sections 112 Standards
Sections 113 Deception of consumers
Sections 118 Registration of drugs, herbal medicinal products,
Sections 119 Cancellation or suspension of
Section 114 Prohibited advertisement
Section 123 (1) Counterfeit drugs, herbal medicinal products,
Section 132 (1)(2)(3) Closure of premises and safe disposal of unwholesome regulated products
Section 135 Powers of authorised officers
Section 147. (1)-(3) Regulations
Section 148. (1)-(3) Guidelines and codes of practice.
Scope of Mandate

The department undertakes post registration surveillance operations for allopathic, veterinary, homeopathic, and herbal medicines as well as food supplements.

Operational Activities

The operational activities for the department are as follows:

i. Post registration product quality monitoring to ensure safety, efficacy and quality has not been varied.
ii. Monitoring the recall of non-conforming products from trade.
iii. Retail outlet inspections/raids/swoops to detect and rid the market of non-conforming products.
iv. Consumer complaints investigations into suspected therapeutic failure, product quality defects and substandard and falsified medicinal products.
v. Advertisement vetting, approval, monitoring and enforcement.
vi. Supervision of safe disposal of non-conforming products.
vii. Detention of non-conforming products.
viii. Inspection of non-conforming products detained by Import Export Control Department.
ix. Drafting of bills.
x. Drafting and review of guidelines and codes of practice.
The Department has three operational units; the Advertisement Monitoring Control Unit, Investigation and Complaint Unit and Quality Monitoring Unit.
vTOBACCO AND SUBSTANCE OF ABUSE DEPARTMENT (TSAD)

The Mandate of the Tobacco and Substance of Abuse Departmen
t is defined by Part 6 of the Public Health Act, 2012, Act 851 and the Tobacco Control of Regulations 2016 (LI 2247).

Scope of Mandate

Department operations cover the utilisation of narcotics 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:

i. Public education on abuse of substances and tobacco and tobacco products.
ii. Allocation of controlled substances to importers.
iii. Audit inspections to prevent the diversion of controlled substances to illicit use.
iv. Issuance of permits for controlled substances -raw material and finished products.
v. Monitoring of controlled substance.
vi. Correspondence with international narcotics bodies.
vii. Stakeholder engagements
viii. Registration and issuance of certificates for tobacco and tobacco products.
ix. Maintain the tobacco register
x. Registration of importers
xi. Monitoring compliance to tobacco control regulations.

The Department has two operational units; the Narcotics Unit, 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 codeine containing cough syrups 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 of November, 2018. All imported registered tobacco products now have the PHWs imprinted on their packages.
5. Ghana has ratified of the Protocol for the Elimination of illicit Trade in Tobacco Products on April 11th, 2019 which aims among others to eliminate 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.

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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