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This document provides the guidelines and requirements for the registration of pharmaceuticals intended for human use within the ASEAN region, including administrative data, product information, and
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How to fill out asean common technical dossier
How to fill out ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
01
Gather all necessary documentation related to the pharmaceutical product.
02
Prepare the product information, including the product name, dosage form, strength, and route of administration.
03
Complete the Common Technical Document (CTD) sections: Module 1 (Administrative Information), Module 2 (Summaries), Module 3 (Quality), Module 4 (Non-clinical Study Reports), and Module 5 (Clinical Study Reports).
04
Include all required certificates such as Good Manufacturing Practice (GMP), stability data, and clinical trial data.
05
Ensure that all documents are translated into the language required by the relevant ASEAN member states.
06
Compile the dossier according to the guidelines set by the ASEAN Secretariat and the respective national regulatory authorities.
07
Submit the completed ACTD to the relevant regulatory authority in the respective country.
Who needs ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE?
01
Pharmaceutical manufacturers seeking to register their medications for human use in ASEAN member states.
02
Research organizations conducting clinical trials in the region.
03
Regulatory affairs professionals working on drug submissions.
04
Distributors and importers planning to market pharmaceuticals within ASEAN countries.
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People Also Ask about
What is the ACTD dossier?
THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE.
What are the ASEAN disclosure standards?
The ASEAN Disclosure Standards Scheme was developed to facilitate cross-border offerings of securities and support fund-raising activity in the region. The Scheme is benchmarked against the International Organization of Securities Commissions' (“IOSCO”) disclosure standards on cross-border offerings.
What is the difference between ICH CTD and ACTD?
The ACTD generally consists of Parts I to IV whereas ICH – CTD has 5 Modules. 3 The authoritative data of Part I is part of ACTD whereas Module 1 of ICH– CTD is purely country specific. The analysis of the quality (Part II), nonclinical (Part III) and clinical (Part IV) are at the beginning of each part of the ACTD.
What is the ASEAN dossier guideline?
This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) application that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals and biologics for human use.
What countries are part of the ASEAN CTD?
The Member States are Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Viet Nam. The ASEAN Secretariat is based in Jakarta, Indonesia.
What are the requirements for ASEAN drug labeling?
The combination of numbers, symbols and letters assigned to the traditional medicines which is approved by the National Regulatory Authority (NRA) shall be declared, if applicable. The complete name and address of the manufacturer of the product shall be declared.
What is the ASEAN catch documentation scheme?
The ASEAN Catch Documentation Scheme (ACDS) is aimed at improving traceability within marine capture fisheries in order to prevent the entry of fish and fishery products from IUU fishing into the supply chain.
What is the ACTD dossier?
This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use.
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What is ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE?
The ASEAN Common Technical Dossier (ACTD) is a standardized template utilized by member countries of the Association of Southeast Asian Nations (ASEAN) to facilitate the registration process for pharmaceuticals intended for human use. It provides a comprehensive framework for the submission of data on a pharmaceutical product, aiming to streamline and harmonize regulatory procedures across member states.
Who is required to file ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE?
Pharmaceutical manufacturers and sponsors seeking to obtain market authorization for their products in ASEAN member countries are required to file the ASEAN Common Technical Dossier (ACTD). This includes both local and foreign pharmaceutical companies that intend to market their products in the region.
How to fill out ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE?
To fill out the ASEAN Common Technical Dossier (ACTD), applicants must follow the structured format outlined in the ACTD guidelines. This includes completing sections related to the product's quality, safety, efficacy, and labeling. It is essential to provide comprehensive and accurate information, ensuring that all required data is included and complies with both the technical requirements and regulatory standards of the specific ASEAN country.
What is the purpose of ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE?
The primary purpose of the ASEAN Common Technical Dossier (ACTD) is to harmonize the submission requirements for pharmaceutical product registration across ASEAN member countries, thereby enhancing efficiency in the regulatory process. It aims to reduce duplication of effort, facilitate faster approvals, and promote the availability of safe and effective medicines in the region.
What information must be reported on ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE?
The ASEAN Common Technical Dossier (ACTD) requires the reporting of several key pieces of information, including but not limited to: product identification, quality control data, results from non-clinical and clinical studies, proposed labeling and packaging details, and information concerning the manufacturing process and stability studies. Each section must be thoroughly documented to ensure compliance with regulatory guidelines.
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