ACTD GUIDELINES

FOR GENERIC PRODUCT

ACTD
ASEAN abbreviates Association of South East

Asian Nations.
Established in 08 August 1967
Ten (10) Member states are Brunei, Cambodia,

Indonesia, Lao, Malaysia, Myanmar, Philippines,

Singapore, Thailand, Viet Nam.

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ORGANIZATION OF ACTD
ACTD documents comprises following parts;

PART I: Table of contents, Administrative Data &

Product Information(Applicable)

PART II: Quality Documents(Applicable)

PART III: Non Clinical Documents(Not Applicable for

generic products)

PART IV: Clinical Documents(Not Applicable for generic

products some exception may apply)

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ORGANIZATION OF
ACTD.Cont
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,
labeling, Product Data Sheet, prescribing information)
Part II : Quality Document
Section A: Table of Contents
Section B: Quality Overall Summary
Section C: Body of Data
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ORGANIZATION OF ACTD
cont
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
4. Toxicology
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ORGANIZATION OF
ACTD.Cont
Part IV : Clinical Document
Section A: Table of Contents
Section B: Clinical Overview
Section C: Clinical Summary
1. Summary of Biopharmaceutics
Analytical Methods

and

Associated

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 ofMarketing
Key Literature
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References

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Module 1
Application form1
Letter of authorization
Certifications
Manufacturer License
GMP Certificate
COPP
Site Master File
Labeling
Product Information
Package Insert
Summary of Product Characteristics
Patient Information Leaflet
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Module 2
Quality overall Summary
Body of data
Drug Substance
General Information
Manufacture
Characterization
Control of Drug substance
Reference standard or materials
Container Closure system
Stability
Drug Product
Description and Composition
Pharmaceutical Development
Manufacture
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Module 2..Cont
Control of Excipient
Control of Finished Products
Reference Standard or materials
Container Closure system
Stability Product
Interchangeability (Comparative Dissolution)

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Module 3..(Not Applicable)

The document of this part is not required
for generic product, minor variation product
and some major variation product. For
ASEAN member countries, the study
reports of this part may not be required for
NCE, Biotechnological product and some
major variation products. if the original
products are already registered and
approved for market authorization in
reference countries.

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REFRENCE: ACTD Guidelines

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Module 4..(Not Applicable)

In the ASEAN region for filing of Generic
Drug their main emphasis on quality
document. They permit the official research
article related to drug product in clinical
Data and literature references.

REFRENCE: ACTD Guidelines

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List of Documents
Required
List of documents required for Part I
Administrative
section writing:
1. Application form (details to be filed in)
2. Letter of Authorization
3. Certifications
i. Manufacturing license
ii. Certificate of Pharmaceutical Product
iii. GMP certificate of the Manufacturer
iv. Site Master File of manufacturer
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List of Documents
RequiredCont
4. Labeling
i. Mock-up for Inner Carton
ii. Mock-up for outer carton
iii. Mock-up for Label
5. Product Information
i. Package Insert
ii. Summary of Product Characteristics (Product Data Sheet)
Summary of Product Characteristics is required for NCE
and
Biotechnology products.
iii. Patient Information Leaflet (PIL)
PIL is required for Over-the-Counter Products Product
Information
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List of Documents
RequiredCont
List of documents required for Part II Quality
section
writing:
1. DMF of API
2. BMR Finished product
3. BPR Finished product
4. Critical manufacturing steps and justifications
5. Process validation protocol and report
6. Flow chart (Detailed and simple)
7. Process development report
8. Impurity profile with justifications
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List of Documents
RequiredCont
9. Excipient details :
Specification and testing method
COA
TSE/BSE declaration from supplier/manufacturer.

10. Specification and method of Analysis (MOA)

Intermediates and in-process specification & MOA
Finished product release specification & MOA
Finished product Stability specification & MOA
API specification & MOA from finished product

manufacturer.
Packaging material (primary, secondary and
tertiary)
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List of Documents
RequiredCont
11. Analytical method validations at release
and stability (if different methods are used)
Assay
Related substance
Dissolution (if applicable)
Preservative content (if applicable)
Sterility (if applicable)
Endotoxin (if applicable)
MLT
Forced degradation

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List of Documents
RequiredCont
12. COAs
API (3 consecutive batches) from FP manufacturer
All the raw material (excipients and coating materials)
Reference and working standards
Impurity standards
Packaging material (primary, secondary and tertiary)

13. IR spectra of PVC/PVDC sheets and aluminum foil

if used
14. Soft copy of labels (PDF)
15. Food grade certificate from primary packaging
material manufacturer for its primary packaging
material
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List of Documents
RequiredCont
16. Preparation of reference standard in brief
17. Stability protocol
18. Stability data and Photo stability data (if
applicable)
19. Bioequivalence study

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