National Drug Authority (NDA)
Yes
Generic Drugs, Biologics, New Drugs
6-12 months
5 Years
6 Months
Provide a detailed table of contents encompassing all modules, facilitating a comprehensive overview of the entire submission.
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.
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.
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.
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.
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)
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
3.1 Table of contents of Module 3
3.2 Body of data
3.3 Literature references
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.