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Date: 2024-08-30 Category: Not Applicable State: Union Government Country: India

Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2024

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Overview

  • This gazette notification pertains to rejected clinical trial applications and permissions (Form CT-04 and CT-06) for the year 2024.
  • It provides details of applications that were rejected during this period.

Key Changes

  • The notification indicates that there were no rejected clinical trial applications or permissions (Form CT-04 and CT-06) in 2024. All fields for rejected applications are listed as 'Nil'.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Analyze internal processes to understand factors contributing to zero rejections and identify areas for continuous improvement. Maintain diligence in preparing and submitting clinical trial applications.

Clinical Research Organizations (CROs)

  • Action Item: Continue to emphasize quality and compliance in clinical trial management. Monitor regulatory updates and adapt processes accordingly.

Regulatory Authorities

  • Action Item: Continue to monitor the quality and completeness of clinical trial applications. Ensure that review processes are efficient and transparent.

Patients

  • Action Item: Advocate for continued improvements in the regulatory review process to facilitate timely access to innovative therapies.

Key Entities Referenced

Form CT-04: Application for permission to conduct clinical trial of new drug or investigational new drug Form CT-06: Application for permission to conduct clinical trial for subsequent new drug or investigational new drug QMS-GNL-019/F02(b)-00: Format number for the document, likely related to the Quality Management System.
Official Source Record View Original Source →
See Full Document Text
Annexure - II(b) Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) Year 2024 S.No. File Firm Name of Phase Title of Application Date of Summary No. Name Product the No./ Rejection study Permission No. 1 Nil Nil Nil Nil Nil Nil Nil Nil Format No. QMS-GNL-019/F02(b)-00.

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