Module 1 2021

25/06/2021

Electronic submissions: Region by region – Other Regions (4)

• The ASEAN Countries • ASEAN countries adopted ASEAN CTD (ACTD) structure in 1999 • ACTD follows the ICH CTD structure with a specific 4 parts format/module structure • Part I: ToC, Administrative Data & Product Information • Part II: Quality Documents • Part III: Non-Clinical Documents • Part IV: Clinical Documents • Some of the ASEAN countries have practiced flexibility in accepting both ICH CTD and ACTD dossiers (e.g. Singapore)

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Electronic submissions: Region by region – Other Regions (5)

• Other Countries • Many other countries will accept CTD format submissions, including the following agencies: • Hong Kong, China, Taiwan, Mexico, Brazil, Argentina • Many other countries accept electronic filings based on their local requirements (NeeS like submissions, individual file uploads with no PLC management) • Russia, Turkey, Egypt, India, Israel, South Korea, Mexico, Venezuela, Bosnia Hercegovina • All of this means that if we work from the high level standards of the eCTD we can work back to the standards acceptable in these countries, and most reviewers would probably like to receive an electronic submission

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