ACTD Guidelines Overview

Phr_ali91@hotmail.com
Overview of Dossier Requirements and
Guidelines for Generic Product
Muhammad Ali
email: phr_ali91@hotmail.com
ACTD
Asean Common Technical Document

Phr_ali91@hotmail.com 2Muhammad Ali

Phr_ali91@hotmail.comPhr_ali91@hotmail.com
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.
• The ASEAN Common Technical Document is organized into four parts. The ACTD
consists of Parts I to IV whereas ICH – CTD has 5 Modules. The administrative data
of Part I is part of ACTD whereas Module 1 of ICH – CTD is purely country
specific. The summaries of the quality (Part II), nonclinical (Part III) and clinical
(Part IV) are located at the beginning of each part of the ACTD. The ICH – CTD
dedicates these summaries in a separate Module 2. As the ACTD does not have
such summary part, it consists of only 4 Parts and not 5.
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ORGANIZATION OF ACTD
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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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ACTD Table of Content
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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 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 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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Overview of Dossier Requirements and Guidelines
Generic Products
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Generic Guide: Definitions
Active Pharmaceutical Ingredient (API)
A substance or compound that is intended to be used in the manufacture of a
pharmaceutical product as a therapeutically active compound (ingredient)
Pharmaceutical Product
Any preparation for human or veterinary use that is intended to modify or explore
physiological systems or pathological states for the benefit of the recipient.
Finished Pharmaceutical Product (FPP)
A product that has undergone all stages of production, including packaging in its
final container and labelling.
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Module 1
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
details is put together such as application forms, label, and package insert etc. The
last section of this part is Product Information where necessary information includes
prescribed information, mode of action, side effects etc.
• Application form1
• Letter of authorization
• Certifications
• Manufacturer License
• GMP Certificate
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Module 1
• COPP
• Site Master File
• Labeling
• Product Information
• Package Insert
• Summary of Product Characteristics
• Patient Information Leaflet
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Module 2
• Part II should provide the Overall Summary followed by the Study Reports. The
quality control document should be described in details as much as possible.
S DRUG SUBSTANCE P DRUG PRODUCT
S1 General Information P1 Description and Composition
S2 Manufacture P2 Pharmaceutical Development
S3 Characterization P3 Manufacture
S4 Control of Drug Substance P4 Control of excipients
S5 Reference Standards or Materials P5 Control of Finished Product
S6 Container Closure P6 Reference Standards or Materials
S7 Stability P7 Container Closure
P8 Stability
P9 Product Interchangeability Equivalence evidence
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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.
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 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
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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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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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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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12. COA’s
– 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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16. Preparation of reference standard in brief
17. Stability protocol
18. Stability data and Photo stability data (if applicable)
19. Bioequivalence study (if applicable)
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Thank you
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ACTD Guidelines Overview

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ACTD Guidelines Overview