Mauritius Drug Product Registration

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

Module 2 of this document encompasses a comprehensive overview and summary of the chemical, pharmaceutical, non-clinical, and clinical aspects related to the product under consideration. The module is structured as follows:

2.1 Overall Table of Contents of Modules 2, 3, 4, and 5: This section provides an outline of the contents covered in Modules 2 to 5 of the document.

2.2 Introduction: This serves as an introductory section setting the context for the information presented in the subsequent sections.

2.3 Overall Quality Summary: This part, designated for office use, includes an assessment of the overall quality aspects of the product.

• 3.1 Overview of Active Pharmaceutical Ingredient(s) [API(s)]: This section provides a detailed overview of the active pharmaceutical ingredient(s) including nomenclature, structure, general properties, manufacture, characterization, control, reference standards, container closure system, and stability.
• 3.2 Overview of Finished Pharmaceutical Product(s) [FPP(s)]: Similarly, this section presents an overview of the finished pharmaceutical product(s) covering aspects such as description, composition, pharmaceutical development, manufacture, control, reference standards, container closure system, and stability.
• 3.3 Appendices: This section includes additional information related to facilities and equipment, adventitious agents’ safety evaluation, and novel excipients.

Module 2: Chemical, Pharmaceutical, Non-clinical, and Clinical Overviews and Summaries continue with:

2.4 Summary of Non-clinical Documentation and Clinical Documentation: This section is divided into two subsections based on the type of application:

• 4.1 For New Chemical Entities: Covers non-clinical overview, non-clinical written and tabulated summaries, clinical overview, and clinical summary.
• 4.2 Generic Drug Applications: Includes a clinical overview and summary focusing on product development rationale, overview of biopharmaceutics studies, summary of biopharmaceutics studies and associated analytical methods, overview and summary of in vitro dissolution tests complementary to bioequivalence studies, and overview and summary of in vitro dissolution tests in support of a biowaiver.

Module 3: Chemical – Pharmaceutical Documentation

3.1 Table of Contents of Module 3: This section outlines the contents covered within Module 3, providing a structured overview of the chemical and pharmaceutical documentation presented in the subsequent sections.

3.2 Body of Data: This section delves into the detailed information related to the chemical and pharmaceutical aspects of the product.

• 2.1 Particulars of Active Pharmaceutical Ingredients(s) [API(s)]:
  • 2.1.1 General Information of the API(S): Offers comprehensive details about the active pharmaceutical ingredient(s), including its general information.
  • 2.1.2 Manufacture of the API(S): Describes the manufacturing processes and controls involved in producing the active pharmaceutical ingredient(s).
  • 2.1.3 Characterization of the API(S): Presents information regarding the characterization of the active pharmaceutical ingredient(s).
  • 2.1.4 Control of the API(S): Details the quality control measures implemented for ensuring the quality and consistency of the active pharmaceutical ingredient(s).
  • 2.1.5 Reference Standards or Materials of the API(S): Discusses the reference standards or materials used for comparison and quality control of the active pharmaceutical ingredient(s).
  • 2.1.6 Container Closure System of the API(S): Provides insights into the container closure system employed for the active pharmaceutical ingredient(s).
  • 2.1.7 Stability of the API(S): Covers the stability aspects of the active pharmaceutical ingredient(s) over time.
• 2.2 Particulars of Finished Pharmaceutical Products(S) [FPP(S)]:
  • 2.2.1 Description and Composition of the FPP(S): Details the description and composition of the finished pharmaceutical product(s).
  • 2.2.2 Pharmaceutical Development of the FPP(S): Covers the pharmaceutical development process of the finished pharmaceutical product(s).
  • 2.2.3 Manufacture of the FPP(S): Describes the manufacturing processes and controls for the finished pharmaceutical product(s).
  • 2.2.4 Control of Excipients for the FPP(S): Explains the measures taken for quality control of excipients in the finished pharmaceutical product(s).
  • 2.2.5 Control of the FPP(S): Details the quality control measures for the finished pharmaceutical product(s).
  • 2.2.6 Reference Standards or Materials of the FPP(S): Discusses the reference standards or materials used for quality control of the finished pharmaceutical product(s).
  • 2.2.7 Container Closure System of the FPP(S): Provides insights into the container closure system employed for the finished pharmaceutical product(s).
  • 2.2.8 Stability of the FPP(S): Covers the stability aspects of the finished pharmaceutical product(s) over time.
• 2.3 Appendices:
  • 2.3.1 Facilities and Equipment: Provides additional information related to facilities and equipment involved in the manufacturing processes.
  • 2.3.2 Adventitious Agents Safety Evaluation: Discusses the safety evaluation concerning adventitious agents.
  • 2.3.3 Novel Excipients: Covers information about novel excipients used in the product formulation.

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

4.1 Table of Contents of Module 4: This section outlines the contents covered within Module 4, providing a structured overview of the non-clinical study reports presented in the subsequent sections.

4.2 Study Reports: This section contains detailed reports on non-clinical studies conducted for new chemical entities. It includes information on the design, methodology, and results of studies aimed at assessing the safety and efficacy of the product.

4.3 Literature References: This part provides a list of references to relevant literature that supports or supplements the non-clinical study reports presented in Module 4.

Module 5: Clinical Study Reports

5.1 New Chemical Entities Only

• 1.1 Table of Content of Module 5: This section outlines the contents covered within Module 5 for new chemical entities, providing a structured overview of the clinical study reports and associated documentation.
• 1.2 Tabular Listing of All Clinical Studies: This part presents a tabular listing summarizing all clinical studies conducted for new chemical entities, providing a concise overview of the scope and nature of each study.
• 1.3 Clinical Study Reports: This section contains detailed reports on each clinical study conducted for new chemical entities, providing information on the study design, patient demographics, methodology, results, and conclusions.
• 1.4 Literature References: Similar to Module 4, this part provides references to relevant literature that supports or supplements the clinical study reports presented in Module 5.

5.2 Interchangeability of Generic Drugs – (Generic Drug Applications Only)

• 2.1 Reports of Biopharmaceutic Study(ies):
  • 2.1.1 Bioavailability (BA) Study Report: Contains detailed reports on bioavailability studies conducted for generic drugs.
  • 2.1.2 In Vitro Dissolution Tests: Provides information on in vitro dissolution tests conducted to assess the performance of generic drugs.
• 2.2 Other Clinical Study Data Done to Support Efficacy and Safety of the Product: This section includes additional clinical study data beyond bioavailability and dissolution tests, aimed at supporting the overall efficacy and safety of generic drugs.

5.3 Safety and Residues Documentation (For Veterinary Products Only)

• 3.1 Requirements for Animal Safety:
  • 3.1.1 Laboratory Animal Studies: Details requirements and findings from laboratory animal safety studies for veterinary products.
  • 3.1.2 Target Animal Safety Studies: Outlines requirements and results of safety studies conducted on the target animal population.
• 3.2 Requirements for Human Safety:
  • 3.2.1 Laboratory Animal Toxicity Studies: Describes requirements and outcomes of toxicity studies conducted on laboratory animals.
  • 3.2.2 Microbiological Safety Studies (For Antimicrobial Products): Provides information on microbiological safety studies, specifically for antimicrobial veterinary products.
  • 3.2.3 Veterinary Antimicrobial Products: Covers requirements and data related to veterinary antimicrobial products.
  • 3.2.4 Residue (Chemistry) Studies/Data for Food Producing Species Only: Details residue studies and chemistry data related to food-producing species, ensuring the safety of food products derived from these animals.

Declaration by an Applicant

1.  I, the undersigned, certify that all information in this application form and accompanying documentation is correct, complete, and true to the best of my knowledge.
2.  I further confirm that the information referred to in my application dossier is available for verification during the current Good Manufacturing Practice (GMP) inspection.
3. I agree that the undersigned has not marketed or advertised this product in Mauritius and will adhere to the OFFICE requirements for advertisements of medicines.
4. I also agree that the undersigned will implement a Pharmacovigilance plan for this product in accordance with OFFICE requirements.
5. I also agree that I am obliged to follow the requirements of the Pharmacy Board, which are related to pharmaceutical products.
6. I also consent to the processing of information provided by the Pharmacy Board.

Name: ________________________________________________________________

Position in company: __________________________________________________

Signature: ____________________________________________________________

Date: ________________________________________________________________

Official stamp: _________________________________________________________