ASEAN common technical dossier (ACTD) for the registration of pharmaceuticals for human use:

ASEAN Common Technical Dossier (ACTD) serves as a standardized framework for preparing comprehensive applications intended for the registration of pharmaceuticals and biologics for human use across ASEAN regulatory authorities. It outlines a structured Common Technical Dossier (CTD) format, facilitating efficient compilation and future electronic submission of registration applications. While the current ASEAN Common Technical Requirements (ACTR) does not specifically address bio-similar products, the ACTD format is deemed suitable for their inclusion. The guideline emphasizes clarity and transparency in presenting technical data, aiming to streamline regulatory reviews and enhance communication between authorities and applicants. Applicants are encouraged to adapt the format to optimize the presentation of their technical information, ensuring thorough comprehension and evaluation during pharmaceutical registration. Standard specifications such as font (Times New Roman, 12-point), paper size (A4 or 8.5″ x 11″), and document layout are prescribed to maintain consistency and readability throughout the dossier. Additionally, guidelines for defining acronyms, abbreviations, and referencing are aligned with established standards to support manuscript clarity and compliance.

The Common Technical Document (CTD) is structured into four main parts:

Part I: Table of Contents, Administrative Data, and Product Information ASEAN 

Part I serves as an introductory section providing an overview of the entire ACTD. It includes:

1. Table of Contents: A comprehensive outline of the entire ACTD.
2. Administrative Data: Detailed documentation required for submission, such as application forms, labeling, and package inserts.
3. Product Information: Essential details about the pharmaceutical product, including prescribed information, mode of action, and potential side effects. This section also introduces the pharmaceutical, including its pharmacologic class and mode of action.

Part II: Quality Document ASEAN 

Part II of the CTD includes:

• Section A: Introduction
• Section B: Overall ASEAN Common Technical Dossier Table of Contents
• Section C: Documents required for registration: This includes specific documents such as application forms,

Part II: Quality Document

Part II of the Common Technical Document (CTD) is dedicated to quality aspects and is divided into three sections:

Section A: Table of Contents

• Provides an outline of the content within the Quality Document.

Section B: Quality Overall Summary

• This section offers a comprehensive overview of the quality aspects of the pharmaceutical product. It includes critical information such as manufacturing processes, controls, specifications, and stability data.

Section C: Body of Data

• Detailed data supporting the quality attributes of the product. This includes analytical methods, validation data, results of stability studies, and other relevant quality-related information.

Part III: Non-clinical Document

Part III focuses on non-clinical data and is structured into four sections:

Section A: Table of Contents

• Outlines the content of the Non-clinical Document.

Section B: Nonclinical Overview

• Provides a summary of the non-clinical studies conducted, including objectives, methods, and key findings.

Section C: Nonclinical Written and Tabulated Summaries

• Detailed summaries of non-clinical data categorized into:
  1. Pharmacology: Study of drug effects on biological systems.
  2. Pharmacokinetics: Study of drug absorption, distribution, metabolism, and excretion.
  3. Toxicology: Study of the adverse effects of the drug on biological systems.

Section D: Nonclinical Study Reports

• Detailed reports of individual non-clinical studies, including:
  1. Table of Contents: Provides an outline of the study report.
  2. Pharmacology: Detailed results and analysis of pharmacological studies.
  3. Pharmacokinetics: Detailed results and analysis of pharmacokinetic studies.
  4. Toxicology: Detailed results and analysis of toxicological studies.

Note: Nonclinical data may not be required for Generic Products, Minor Variation Products, and some Major Variation Products. Additionally, Study Reports may not be necessary if the Original Products are already registered and approved in Reference Countries. Regulatory authorities may request specific Study Reports as needed. The term “Nonclinical” is used interchangeably with “Pre-clinical” in this context.

Part IV: Clinical Document

Part IV of the Common Technical Document (CTD) focuses on clinical data and is structured into several sections:

Section A: Table of Contents

• Provides an outline of the content within the Clinical Document.

Section B: Clinical Overview

• Offers a comprehensive summary of the clinical development program for the pharmaceutical product. This includes an overview of the bio-pharmaceutics and associated analytical methods used.

Section C: Clinical Summary

• Detailed summaries of clinical data categorized into:
  1. Summary of Bio-pharmaceutics and Associated Analytical Methods: Describes the methods used to analyze the pharmaceutical product in biological systems.
  2. Summary of Clinical Pharmacology Studies: Provides an overview of how the drug behaves in the human body, including absorption, distribution, metabolism, and excretion (ADME).
  3. Summary of Clinical Efficacy: Summarizes the effectiveness of the drug based on clinical trials.
  4. Summary of Clinical Safety: Summarizes the safety profile of the drug based on clinical trials.
  5. Synopses of Individual Studies: Provides brief summaries of each individual clinical study conducted.

Section D: Tabular Listing of All Clinical Studies

• Provides a structured tabular listing of all clinical studies conducted, including study title, objectives, design, patient demographics, and key findings.

Section E: Clinical Study Reports

• Detailed reports of individual clinical studies, including methodologies, results, and statistical analyses.

Section F: List of Key Literature References

• Provides a list of references cited throughout the Clinical Document.

Note: Similar to Parts II and III, clinical data may not be required for Generic Products, Minor Variation Products, and some Major Variation Products. Study Reports may also not be required for New Chemical Entities (NCEs), Biological Products, and other Major Variation Products if the Original Products are already registered and approved in Reference Countries. Regulatory authorities may request specific Study Reports as necessary for evaluation purposes.