ACTD GUIDELINES

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Overview of Dossier Requirements and Guidelines for Generic Product

Muhammad Aliemail: [email protected]

ACTDAsean Common Technical Document

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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

Health & Medicine