A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

 

 

ASEAN COMMON TECHNICAL DOCUMENT [ACTD][19-22]

ASEAN Introduction
The Association of South-East Asians Nations (ASEAN) is a regional organization consisting of ten member countries, namely, Brunei Darussalam, Cambodia, Indonesia, Laos, Myanmar, Malaysia, Philippines, Singapore, Thailand and Vietnam.
ASEAN was established in 8 August 1967 by the governments of five countries - Indonesia, Malaysia, Philippines, Singapore and Thailand. In 1984, Brunei Darussalam joined its neighbors in the association. As a group, these early participants are dubbed the ASEAN6. Vietnam has become member since 1995, Laos and Myanmar since 1997 and Cambodia since 1999. These four new members are usually referred to as the CLMV group.
In 1992, the governments of ASEAN member countries agreed to create the ASEAN Free Trade Area (AFTA) to set common tariff scheme. The agreement on Common Effective Preferential Tariff Scheme (CEPT) has been effective since 2003. Pharmaceutical trade among the members now enjoy import duties of 0-5 % under CEPT, provided that the products has no less than 40% local content.
A Pharmaceutical Product Working (PPWG) was established to work on the details in the development of harmonization guidelines for technical procedures and requirements partially applicable to the ASEAN pharmaceuticals have been identified for harmonization - quality, efficacy, safety and administrative data.
Key documents resulted from work of PPWG include :
- ASEAN Common Technical Requirements (ACTR) for pharmaceutical product registration (for human use).
- ASEAN Common Technical Dossier (ACTD) for pharmaceutical product registration (for human use).
- ASEAN Guidelines on the following areas : analytical validation, bioavailability and bioequivalence studies, process validation, stability.
While ASEAN was working on its harmonized pharmaceutical registration, another international collaboration for harmonization of pharmaceutical registration was taking place in parallel called the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It was established in 1990 and works for development for technical guidelines for registration of pharmaceutical products to achieve greater harmonization.

ASEAN Pharmaceutical Product [24]
At the first PPWG meeting the terms of reference were agreed and it was decided that the topics selected for harmonization would be divided into safety, quality and efficacy to reflect the three criteria which would be the basis for approving medicinal products. One of the PPWGs key topic is the idea of an ‘ASEAN pharmaceutical product’. This means that same regulatory requirements apply for the registration of a medicinal product among the ASEAN member countries. The PPWG developed the ASEAN Glossary of terms, the ACTD, the ACTR and their guidelines.
The ACTD gives information on the format and structure of the dossier that shall be commonly used for applications in the ASEAN region. The ACTD should serve as a locator for documentation that has been compiled for a marketing authorization application. It does not give any recommendations on the actual content of the dossier. The ACTD is similar to the European Notice to Applicants Volume 2B Presentation and Format of the dossier (EU-CTD).

The ACTR is as set of written material intended to guide applicants to prepare an application in a way that is consistent with the expectations of all ASEAN Drug Regulatory Authorities. It is a guide for preparation of the ACTD.
For Pharmaceuticals, efforts to develop harmonization schemes of pharmaceutical regulations in ASEAN to facilitate trade in pharmaceuticals continued and for this ATCD, covering administrative data, quality, safety and efficacy and an ASEAN Common Technical Requirements (ATCRs), covering quality, safety and efficacy had developed. The ACTD is the part of marketing authorization application dossier that is common to all ASEAN member countries while the ATCR is the set of written materials, intended to guide applicant(s) to prepare application dossiers in a way that is consistent with the expectations of all ASEAN Drug Regulatory Authorities. Series of guidelines for the implementation of the ATCR are being finalized. The ASEAN Standards and Quality Bulletin is regularly published with a view to ensure dissemination of information and promote transparency on standards, technical regulations and conformity assessment procedures in ASEAN member countries.

Regulatory Agencies in South East Asia
Table 6 : List of countries and their Regulatory Authority (ACTD) [19-20]

Country

Regulatory Agencies

Indonesia

National Agency of Drug & Food Control

Malaysia

Drug Control Authority, NCE Unit

Philippines

Department of Health

Thailand

Thai FDA Drug Control Division

Singapore

Health Sciences Authority (HSA)

Brunei

Ministry of Health

Vietnam

Drug Administration of Vietnam

Myanmar

Food and Drug Administration

Cambodia

Department of Drug, Food and Cosmetics

Laos PDR

Ministry of Health, Food And Drug Department (FDD)

ORGANIZATION OF ASEAN CTD (ACTD) FORMAT [23]
ACTD is a guideline for the preparation of a well-structured CTD applications that would be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that would significantly reduce the time and resources needed to compile applications for registration and in the future, would ease the electronic document submissions.
 Four parts are :
- Part I : Table of Contents, Administrative Data and Product Information
- Part II : Quality Document
- Part III : Nonclinical Document
- Part IV : Clinical Document
Presenting above information in the organizational structure which is known as ACTD Triangle.
The organizational structure is detailed with the help of technical data of ASEAN common technical document (ACTD) which is mentioned in all part of respective dossier.

upon request 
Fig. 2 Organizational Structure of ACTD
This format is explained with selected drug Alogliptin for Singapore.

Overview of ICH-CTD and ACTD
In this thesis  an attempt has been made to compare the drug regulatory approval procedure and requirements for the registration of pharmaceuticals for human use in ICH countries and ASEAN. The main points of divergence are in the content and format of the registration dossier.
The ACTD consists of Parts I to IV which have subsections A to F whereas ICH-CTD has 5 Modules with subsections that are numbered. 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. The major differences between the ICH-CTD and ACTD are listed below in Table.

Table 7 : DOCUMENTS LOCATION IN FORMAT OF ICH-CTD & ASEAN CTD [13]

ICH CTD

ASEAN CTD

Description

Remarks

Module 1 -Regional and Administrative Information

Part I

Contains documents that are specific to each region. This module is not part of CTD. Basically consists of administrative documents like Application form, legal documents (GMP, Licenses etc.), labeling etc.

Required for generics and New Drug.

Module 2 - Overall Summary

Incorporated in Parts II, III and IV

This module summarizes the Module 3, 4 and 5. It includes Quality Overall summary, Non Clinical Overview and Summary and Clinical Overview and Summary. The summary provides reviewer the abstract of documents provided in the whole application.

Required for generics and New Drug. For generics summary on Quality part only required.

Module 3 - Quality

Part II

The documents related to Chemistry, manufacturing and Control of both Drug Substance and Drug Product is included in this module.

Required for generics and New Drug.

Module 4 - Safety

Part III

Non Clinical Study Reports – Data on pharmacologic, pharmacokinetic, and toxicological evaluation of the pharmaceutical product is provided.

Not required for generics.

Module 5 -Efficacy

Part IV

Clinical Study Reports - A critical assessment of the clinical data and related reports is provided in this module.

Not required for generics except Bioequivalence study.

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