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Ministry Of Health, Uganda Approval Processes for Pharmaceutical Products

Regulatory Authority:

National Drug Authority (NDA)

Local Authorised:

Yes

Classification:

Generic Drugs, Biologics, New Drugs

Registration Timeline:

6-12 months

License Validity:

5 Years

Valid up to:

6 Months

Procedure For Submission of Application in CTD Format:

  1. a) The application must be in English. A certified or notarized English translation should accompany any documents in a language other than English.
  2. b) The application must include a comprehensive index for easy reference to various appendices.
  3. c) Summaries (Quality Information Summary, Quality Overall Summary, Bioequivalence Trial Information, Biopharmaceutical Classification System (BCS), and additional strength Biowaiver Application Forms) should be formatted as Word documents. The body data must be in PDF format, featuring bookmarks and optical character recognition (OCR) for readability.
  4. d) All pages of the application must be numbered in the format: page x of y.
  5. e) Marketing Authorization application fees must be paid before submitting the application. Refer to the NDA website for fee regulations.
  6. f) Payment of fees can be made to the National Drug Authority, with account details for both UGX and US Dollars provided. Payments can be made at Stanbic Bank Uganda, Kampala.
  7. g) Submit the application in CD-ROM format, addressed to The Secretary to the Authority, National Drug Authority.
  8. h) All submissions, including QIS/QOS P-D, PIL, BTIF, and the Summary of the Product Characteristics, should follow the exact format/template prescribed in the appendices of this guideline.
  9. i) Each product requires a separate application. The determination of products being the same or separate is based on specific criteria outlined in the guidelines. Clarify whether products are considered the same or separate in the application.

Additional Information:

  1. a) In cases where the information or documents submitted with an application for registration are insufficient for the Authority to determine whether the product meets the quality, safety, and efficacy requirements, the Authority may request the applicant to provide additional information necessary for registration. The applicant will receive a letter outlining the specific requirements.
  2. b) The applicant is granted a period of 6 months from the date of the letter to provide the complete and accurate information as requested. Failure to comply within this timeframe may affect the processing of the application.
  3. c) During the assessment, only consequential changes will be accepted. Major changes or additions to the submitted application before registration will necessitate the resubmission of the entire application with the updated information.

Module 1: Administrative Information and Product Information

  1. Comprehensive Table of Contents for All Modules (1.1)

Provide a detailed table of contents encompassing all modules, facilitating a comprehensive overview of the entire submission.

  1. Cover Letter (1.2)

Include a cover letter following the format specified in the provided guidelines (Appendix 1Format for CTD Cover Letter). The letter, signed by the proposed Holder of a Certificate of Registration, should be placed at the beginning of Module 1.

  1. Comprehensive Table of Contents (1.3)

Within Module 1, include a comprehensive table of contents for the entire application. Clearly list all documents provided in the application by module, referring to volume numbers and tab identifiers.

  1. Quality Information Summary (QIS) (1.4)

Complete the Quality Information Summary (QIS) template (Appendix 2Template for Quality Information Summary). The QIS should offer a condensed summary of key quality information for the Product Dossier (PD), serving as an accurate record of technical data in the PD at the time of prequalification.

  1. Product Information (1.5)

Present information related to the product:

5.1 Prescribing Information (Summary of Product Characteristics) (1.5.1)Refer to Appendix 3 for guidelines on the format and content of the Summary of Product Characteristics for pharmaceutical products.

5.2 Container Labelling (1.5.2)Include details about container labelling for the product.

5.3 Patient Information Leaflet (PIL) (1.5.3)Provide a patient information leaflet, especially for medicinal preparations with potential for long-term use and self-administered injections.

5.4 Mock-ups and Specimens (1.5.4)Include mock-ups and specimens for a visual representation of the product.

  1. Information about the Experts (1.6)
  2. APIMFs and Certificates of Suitability to the Monographs of the European Pharmacopoeia (1.7)
  3. Good Manufacturing Practice (1.8)
  4. Regulatory Status within EAC and in Countries with SRAs (1.9)

9.1 List of Countries in EAC and Countries with SRAs in Which a Similar Application Has Been Submitted (1.9.1)

9.2 Evaluation Reports from EAC-NMRA (1.9.2)

9.3 Evaluation Reports from SRAs (1.9.3)

9.4 Manufacturing and Marketing Authorization (1.9.4)

  1. Paediatric Development Program (1.10)
  2. Product Samples (1.11)
  3. Requirement for Submission of a Risk Mitigation Plan (1.12)
  4. Submission of Risk Management Plan (RMP) (1.13)

Module 2: Overview And Summaries

2.1 Table of contents of Module 2

2.2 CTD Introduction

2.3 Quality overall summary product dossier (QOS-PD)

2.4 Nonclinical overview for new chemical entities

2.5 Clinical Overview

   2.5.1 Product Development Rationale

   2.5.2 Overview of Biopharmaceutics

   2.5.3 Overview of Clinical Pharmacology

   2.5.4 Overview of Efficacy

   2.5.5 Overview of Safety

   2.5.6 Literature References

2.6 Non-clinical Written and Tabulated Summaries

   2.6.1 Benefits and Risks Conclusions

   2.6.2 Introduction

   2.6.3 Nonclinical Written Summary

   2.6.4 Nonclinical Tabulated Summary

   2.6.5 Pharmacology Written Summary

   2.6.6 Pharmacology Tabulated Summary

   2.6.7 Toxicokinetics Summary

   2.6.8 Toxicokinetics Tabulated Summary

2.7 CTD Introduction

 2.7.1 Summary of Biopharmaceutics Studies and Associated Analytical Methods

Module 3: Quality

3.1 Table of contents of Module 3

3.2 Body of data

3.3 Literature references

Module 4: Non-Clinical Study Reports

Module 5: Clinical Study Reports

5.1 Table of Contents of Module 5

5.2 Tabular Listing of All Clinical Studies

5.3 Clinical Study Reports

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