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Asean Common Technical Dossier (ACTD) : The ASEAN Secretariat Jakarta

This document provides guidelines for organizing an ASEAN Common Technical Dossier (ACTD) for pharmaceutical registration. The ACTD contains four parts: I) administrative information and product details, II) quality documentation, III) nonclinical documentation (not required for all product types), and IV) clinical documentation (also not required for all product types). Each part includes a table of contents, overview sections, written summaries, tabulated summaries, and individual study reports as appropriate. The goal of the standardized ACTD format is to facilitate regulatory review and communication during the registration process.

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224 views6 pages

Asean Common Technical Dossier (ACTD) : The ASEAN Secretariat Jakarta

This document provides guidelines for organizing an ASEAN Common Technical Dossier (ACTD) for pharmaceutical registration. The ACTD contains four parts: I) administrative information and product details, II) quality documentation, III) nonclinical documentation (not required for all product types), and IV) clinical documentation (also not required for all product types). Each part includes a table of contents, overview sections, written summaries, tabulated summaries, and individual study reports as appropriate. The goal of the standardized ACTD format is to facilitate regulatory review and communication during the registration process.

Uploaded by

pate malabanan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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ASEAN COMMON TECHNICAL DOSSIER

(ACTD)

The ASEAN Secretariat


Jakarta

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TABLE OF CONTENTS

Part 1 – Organisation of the Dossier . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 3

Part 2 – Quality of Document . . . . . . . . . . . . . . . . . . . . . . . 7

Part 3 – Nonclinical Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 33

Part 4 – Clinical Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

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THE ASEAN COMMON TECHNICAL DOSSIER (ACTD)
FOR THE REGISTRATION OF PHARMACEUTICALS
FOR HUMAN USE

ORGANIZATION OF THE DOSSIER

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THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE
REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ORGANIZATION OF THE DOSSIER

PREAMBLE

This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common
format for the preparation of a well-structured Common Technical Dossier (CTD) application
that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals
and biologics for human use. Although the current ASEAN Common Technical Requirements
(ACTR) has not included specific requirements for biosimilar products, the ACTD format is
also applicable for biosimilar products. This guideline describes a CTD format that will
significantly reduce the time and resources needed to compile applications for registration and
in the future, will ease the preparation of electronic documental submissions. Regulatory
reviews and communication with the applicant will be facilitated by a standard document of
common elements.

This guideline merely demonstrates an appropriate write-up format for acquired data. However,
applicants can modify, if needed, to provide the best possible presentation of the technical
information, in order to facilitate the understanding and evaluation of the results upon
pharmaceutical registration.

Throughout the ACTD, the display of information should be unambiguous and transparent, in
order to facilitate the review of the basic data and to help a reviewer become quickly oriented
to the application contents. Text and tables should be prepared using margins that allow the
document to be printed on either A4 or 8.5ʹʹ x 11ʹʹ paper. The left-hand margin should be
sufficiently large that information is not obscured by the method of binding.

Font and size, (Times New Roman, 12-point font), for text and tables should be of a style and
size that are large enough to be easily legible, even after photocopying. Every page should be
numbered, with the first page of each part designated as page 1. For a paper, Common
Technical Acronyms and abbreviations should be defined the first time they are used in each
part. References should be cited in accordance with the 1979 Vancouver Declaration on
Uniform requirements for Manuscripts Submitted to Biomedical Journals.

The Common Technical Document is organized into four parts as follows:

Part I. Table of Contents, Administrative Data and Product Information


Part I contains initially the overall Table of Contents of the whole ACTD to provide basically
the information that could be looked through respectively. Secondly, the next content is the
Administrative Data where required specific documentation in detail is put together such as
application forms, label, package insert etc. The last section of this part is Product Information
where necessary information includes prescribed information, mode of action, side effects etc.
A general introduction to the pharmaceutical, including its pharmacologic class and mode of
action should be included.

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Part II. Quality Document
Part II should provide the Quality Overall Summary followed by the Body of Data. The quality
control document should be described in detail as much as possible.

Part III. Nonclinical1 Document


Part III should provide the Nonclinical Overview, followed by the Nonclinical Written
Summaries and the Nonclinical Tabulated Summaries. The documentation of this part is not
required for Generic Products, Minor Variation Products and some Major Variation Products.
For ASEAN member countries, the Study Reports of this part may not be required for NCE,
Biological Products and other Major Variation Products if the Original Products are already
registered and approved for market authorization in Reference Countries. Therefore, the
authority who requires specific Study Reports should ask for the necessary documents.
1
The word “Nonclinical” replaces “Pre-clinical”

Part IV. Clinical Document


Part IV should provide the Clinical Overview and the Clinical Summary. The documentation
of this part is not required for Generic Products, Minor Variation Products and some Major
Variation Products. For ASEAN member countries, the Study Reports of this part may not be
required for NCE, Biological Products and other Major Variation Products if the Original
Products are already registered and approved for market authorization in Reference Countries.
Therefore, the authority who requires specific Study Reports should ask for the necessary
documents.

The overall organisation of the Common Technical Dossier is presented on the following in
Parts:

Part I: Table of Content Administrative Information and Prescribing Information


Section A: Introduction
Section B: Overall ASEAN Common Technical Dossier Table of Contents
Section C: Documents required for registration (for example, application forms,
labelling, Product Data Sheet, prescribing information)

Part II: Quality Document


Section A: Table of Contents
Section B: Quality Overall Summary
Section C: Body of Data

Part III: Nonclinical Document


Section A: Table of Contents
Section B: Nonclinical Overview
Section C: Nonclinical Written and Tabulated Summaries
1. Table of Contents
2. Pharmacology
3. Pharmacokinetics
4. Toxicology
Section D: Nonclinical Study Reports
1. Table of Contents
2. Pharmacology
3. Pharmacokinetics

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4. Toxicology

Part IV: Clinical Document


Section A: Table of Contents
Section B: Clinical Overview
Section C: Clinical Summary
1. Summary of Biopharmaceutics and Associated Analytical Methods
2. Summary of Clinical Pharmacology Studies
3. Summary of Clinical Efficacy
4. Summary of Clinical Safety
5. Synopses of Individual Studies
Section D: Tabular Listing of All Clinical Studies
Section E: Clinical Study Reports
Section F: List of Key Literature References

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