ACTD Guidelines Overview

1. Prepared by: Muhammad Ali
ACTD GUIDELINES
FOR GENERIC PRODUCT

2. 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.
Prepared by Ali

3. 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)
Prepared by Ali

4. 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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5. 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
Prepared by Ali

6. ORGANIZATION OF
ACTD….Cont’
PartIV:ClinicalDocument
SectionA:TableofContents
SectionB:ClinicalOverview
SectionC:ClinicalSummary
1.SummaryofBiopharmaceuticsandAssociatedAnalytical
Methods
2.SummaryofClinicalPharmacologyStudies
3.SummaryofClinicalEfficacy
4.SummaryofClinicalSafety
5.SynopsesofIndividualStudies
SectionD:TabularListingofAllClinicalStudies
SectionE:ClinicalStudyReports
SectionF:ListofKeyLiteratureReferences
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7. 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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8. 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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9. Module 2…..Cont’
Control of Excipient
Control of Finished Products
Reference Standard or materials
Container Closure system
Stability Product
Interchangeability (Comparative Dissolution)
Prepared by Ali

10. 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.
REFRENCE: ACTD Guidelines
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11. 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
Prepared by Ali

12. 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
Prepared by Ali

13. List of Documents
Required…Cont’
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
Prepared by Ali

14. List of Documents
Required…Cont’
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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15. List of Documents
Required…Cont’
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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16. List of Documents
Required…Cont’
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
Prepared by Ali

17. List of Documents
Required…Cont’
12. COA’s
API (3 consecutive batches) from FP manufacturer
All the raw material (excipientsand 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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18. List of Documents
Required…Cont’
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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