ACTD (Asian Common Technical Document) Framework

The ACTD (Asian Common Technical Document) is a framework developed to harmonize regulatory submission formats across various Asian countries. It aims to standardize and streamline the process for pharmaceutical and medical device submissions in the region. Here’s a summary of the ACTD publishing requirements and its structure:

1. Overview of ACTD

Objective: The ACTD was developed to create a unified submission format to facilitate regulatory processes across Asian countries, including ASEAN member states and others. It is intended to simplify and harmonize submissions to improve efficiency and consistency in the regulatory approval process.

Scope: ACTD applies to pharmaceuticals and, in some cases, medical devices. It provides guidelines on how to organize and present regulatory documents for drug submissions.

2. Structure of ACTD

The ACTD is organized into several modules, each addressing different aspects of the submission. The structure is designed to be similar to the Common Technical Document (CTD) used in other regions, such as the EU and the FDA. Here’s how the ACTD is typically organized:

Module 1: Administrative Information and Prescribing Information

Application Form: Forms and administrative information specific to the regulatory authority.

Labeling: Draft labeling, package inserts, and instructions for use.

Module 2: Common Technical Document Summaries

2.1 Table of Contents: Overview of the submission.

2.2 Introduction: Summary of the submission and product information.

2.3 Quality Overall Summary: Summary of the quality aspects of the drug product.

2.4 Nonclinical Overview: Summary of nonclinical (preclinical) data.

2.5 Clinical Overview: Summary of clinical data and clinical study results.

2.6 Nonclinical Written and Tabulated Summaries: Detailed nonclinical data and results.

2.7 Clinical Summary: Detailed clinical data, including study results.

Module 3: Quality

3.1 Drug Substance: Information on the drug substance’s quality, including manufacturing, control, and stability.

3.2 Drug Product: Information on the drug product’s quality, including formulation, manufacturing, and control.

Module 4: Nonclinical Study Reports

4.1 Study Reports: Detailed reports of nonclinical studies, including pharmacology, toxicology, and pharmacokinetics.

Module 5: Clinical Study Reports

5.1 Study Reports: Detailed reports of clinical studies, including clinical trials, efficacy, and safety data.

3. Submission Requirements

Document Format: Documents should be provided in PDF format, following guidelines for formatting and accessibility. This includes ensuring that documents are properly bookmarked and indexed.

Electronic Submission: Many regulatory authorities in Asia now accept or require electronic submissions. The ACTD format supports electronic submissions, with guidelines aligning with the use of eCTD (electronic Common Technical Document) where applicable.

Translation: Some Asian countries may require translations of certain documents into the local language. It is essential to verify specific requirements for each country.

4. Country-Specific Requirements

While the ACTD provides a standardized format, individual countries may have additional or slightly varied requirements. Here are some examples:

• China: The National Medical Products Administration (NMPA) has specific submission requirements and may require additional documentation or translations.
• Japan: The Pharmaceuticals and Medical Devices Agency (PMDA) follows its guidelines, which may include specific formatting and submission requirements beyond ACTD.
• India: The Central Drugs Standard Control Organization (CDSCO) aligns with ACTD but may have additional country-specific requirements.

5. Implementation and Updates

Harmonization Efforts: The ACTD is part of broader regional harmonization efforts and is regularly updated to reflect changes in regulatory practices and requirements.

Regional Workshops and Training: To facilitate the implementation of ACTD, regional workshops and training sessions may be conducted to help stakeholders understand and comply with the requirements.

Summary

The ACTD aims to standardize and harmonize regulatory submissions across Asian countries for pharmaceuticals and, in some cases, medical devices. It is structured similarly to the CTD, with specific modules for administrative information, quality, nonclinical, and clinical data. Submissions should be prepared in PDF format and follow the electronic submission guidelines. However, individual countries may have additional requirement