November 2008

ASEAN
= Association of Southeast Asian Nations
Member
- Brunei Darussalam
-Cambodia
- Indonesia
-Lao PDR

-Malaysia

-Myanmar
-Philippines
-Singapore
-Thailand
-Vietnam
 Conclusion: Challenges & Opportunities
Current GMP and ASEAN Harmonized Requirements
and Products (ACTD,GL) for Registration

Opportunity for GLOBAL and Challenges to accept New Concept

REGIONAL Competitiveness & to meet New Requirements

Strengthening ASEAN pharmaceutical industry technical &

managerial competencies at regional / international level

• Requiresconsistent COMMITMENT from :

- pharmaceutical industry in fulfilling requirement
- government in providing direction and regulatory support
PPWG
TFDA

ACCSQ/PPWG
ASEAN Consultative Committee
for Standards and Quality /
Pharmaceutical Product Working Group
Target date for Implementation of ACTD

 Singapore and Malaysia : 31 December 2005

 Thailand : 31 December 2006

 Vietnam and Indonesia : 31 December 2007

 Brunei Darussalam, Cambodia,

Lao PDR and Philippines : 31 December 2008
 TFDA

Agreement :
ASEAN Quality gls

•Analytical Validation guideline

•BA/BE Studies guideline
•Process Validation guideline
•Stability Study guideline
 ORGANIZATION OF APPLICATION
DOSSIER
Country-specific
administrative data.

Part I
Administrative Data
& Product Information
ACTD
Part II Part III Part IV
Quality Non-clinical Clinical
Overall Summary Overview, Overview,
Summary Summary,
& Reports
& Study Reports* Assessment Reports,
& Study Reports*

* Upon Request
 ACTR
A set of Written Materials
intended to guide applicants
to prepare application dossiers
in a way that is consistent with the expectations
of
all ASEAN Drug Regulatory Authorities

ACTD
The part of
marketing authorization application dossier
that is common
to
all ASEAN member countries
Content of ACTR
Drug Substance
- General info.
- Manufacture
- Characterization
- Control of Drug Substance - Ref. Std. or Materials
- Container Closure System
- Stability
Drug Product
- Description and Composition
- Pharmaceutical Development
- Manufacture
- Control of Excipients
- Control of Finished Product
- Ref. Std. or Material
- Container Closure System
- Stability
- Product Interchangeability/Equivalence evidence
ACTR - Safety
Pharmacology
- Primary Pharmacodynamics
- Secondary Pharmacodynamics
- Safety Pharmacology
- Pharmacodynamic Drug Interaction

Pharmacokinetics
- Absorption
- Distribution
- Metabolism (inter-species comparison)
- Excretion
- Pharmacokinetic Drug Interaction(Non-clinical)
- Other Pharmacokinetic Studies
ACTR - Safety
Toxicology
- Single Dose Toxicity
- Repeat Dose Toxicity
- Genotoxicity
- Carcinogenicity
- Reproductive & Development Toxicity

Local Tolerance

Other Toxicity Studies

List of Key Literature Ref.

ACTR - Clinical Data
 BA & BE Studies
- BA Studies
- Comparative BA or BE Studies
 Studies Pertinent to Pharmacokinetics
Using Human Biomaterials
 Human Pharmacokinetic Studies
 Human Pharmacodynamic Studies
 Efficacy and Safety
 Post Marketing Data (if available)
 References
Content of ACTD
Part 1: ToC Admin .Data & Product Info.
Section A: Introduction
Section B: Overall ACTD-ToC
Section C: Doc. Required for Registration

Part 2 : Quality Document

Section A: ToC
Section B: Quality Overall Summary
Section C: Body of Data
Content of ACTD
Part 3 : Non-clinical / Safety Document
 Section A: ToC
 Section B: Non-clinical Overview
 Section C: Non-clinical Written &
Tabulated Summaries
 Section D: Non-clinical Study Reports*
Content of ACTD
Part 4 : Clinical / Efficacy Document
 Section A: ToC
 Section B: Clinical Overview
 Section C: Clinical Summaries
 Section D: Tabular Listing of All Clinical
Studies
 Section E: Clinical Study Reports*
 Section F: List of Key Literature
 References

Note:
ToC = Table of Content
* = Upon REQUEST
TERIMAKASIH