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Ghana Drug Product Registration

Ministry of Health, Republic of Ghana New Drug and Generic Drug Registration – Food and Drugs Authority (FDA)

Regulatory Authority: Food and Drugs Authority (FDA)

Link for Regulatory Authority: https://www.fdaghana.gov.gh/

Local Authorised: Yes

Registration Timeline: 12-18 months

Registration Fee: GHS 6,000 (around USD 1,000).

License Validity: 5 Years

Submission of Drug Registration Applications

  • An applicant must submit a written application for drug registration, whether locally manufactured or imported, accompanied by a cover letter.
  • The cover letter should explicitly state that the information submitted is true and accurate.
  • For foreign companies, a local agent must be appointed through whom the application is submitted.
  • The local agent should be a registered pharmaceutical wholesale company or an accredited manufacturer’s representative in Ghana.
  • Applications, submitted through the authorized local agent, should be addressed to the Chief Executive Officer of the Food and Drugs Authority at the provided address.

Categorization of Applications: Applications are classified into three categories:

  • New Applications for Registration:
    • For introducing a medicinal product to the Ghanaian market for the first time.
    • Submitted by the applicant, with the applicant signing the declaration section of the FDA application form.
    • Separate applications required for products differing in active ingredients, strength, dosage forms, or proprietary names.
    • Only one application required for products with the same active ingredients, strength, and manufacturer, differing only in packaging or pack sizes.
    • Requirements include electronic copies, samples, reference standards, application and inspection fees.
  • Applications for Renewal of Registration:
    • Renewal must be applied for at least 3 months before the existing registration expires.
    • Submission includes a filled re-registration form, safety update reports, samples, and renewal and inspection fees.
  • Application for Variation of a Registered Medicinal Product:
    • Follow specific guidelines outlined in the FDA Application Guideline for Variation of Registered Medicinal Products.

Payment of Fees:

  • Every application must be accompanied by appropriate fees at the time of submission.
  • Applications without accompanying fees will not be accepted.
  • Failure to renew within three years after expiration results in the application being treated as a new registration.

Specific modules required as pr CTD

Module 1: Administrative Information and Prescribing Information

  1. Cover letter
  2. Table of contents of the application
  • Application information such as trade name, dosage form, strength, etc.
  1. Details of the manufacturer
  2. Prescribing information including product information for health professionals, patient information leaflet, and labelling

Module 2: CTD Summaries Chemical, Pharmaceutical, Non-Clinical and Clinical

  1. CTD Table of contents
  2. Quality Overall Summary (QOS)
  • Description and Composition of the Drug Product
  1. Pharmaceutical Development
  2. Manufacture
  3. Control of Excipients
  • Stability

Module 3: Quality

  1. Table of Contents
  2. Active Pharmaceutical Ingredient(S) [API(S)]/ Drug Substance
  • Body of Data
  1. Chemical-Pharmaceutical Documentation

Module 4: Non-Clinical Study Reports for New Chemical Entities Only

This module includes detailed requirements for non-clinical study reports for new chemical entities. It outlines the specific data and information needed for the non-clinical evaluation of the drug’s safety and efficacy.

Module 5: Clinical Study Reports

Module 5 provides guidelines for the submission of clinical study reports. It includes requirements for presenting the results of clinical trials, ensuring that the data is comprehensive and supports the safety and efficacy of the drug.

For Generic

REQUIREMENTS

  1. Completed Application Form.
  2. Samples as per the FDA sample schedule.
  3. Prescribed application fee of $3600.
  4. Dated and signed specification(s) of active pharmaceutical ingredient(s) (APIs).
  5. Certificate(s) of analysis (COA) of active pharmaceutical ingredient(s) (APIs).
  6. Declaration by the finished pharmaceutical product (FPP) manufacturer of the API source. 7. Dated and signed release specification of the FPP.
  7. Certificates of analysis for at least three (3) batches of FPP.
  8. GMP certificate of the manufacturer of the FPP.

10.Shelf life of imported medicines should be in accordance with existing Guidelines on Importation of Allopathic Medicines.