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Date: 2023-03-15 Category: Not Applicable State: Union Government Country: India

Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2022

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 the rejection of clinical trial applications and permissions in the year 2022.
  • The notification provides details of rejected applications using Form CT-04 and CT-06.
  • The format number for this notification is QMS-GNL-019/F02(b)-00.

Key Changes

  • There were no clinical trial applications or permissions rejected in 2022 according to this notification.
  • The table provided to list rejected applications is empty, indicated by 'Nil' in all columns.

Impact Analysis

Pharmaceutical Companies

  • Action Item: While this specific notification has no negative impact, companies should continue to ensure high-quality submissions and adherence to regulatory guidelines to maintain a positive approval rate.

Research Institutions

  • Action Item: Maintain focus on robust research methodologies and ethical practices in clinical trials to ensure continued success in application approvals.

Regulatory Bodies

  • Action Item: Continue monitoring application quality and provide guidance to applicants to maintain high standards and minimize future rejections. Analyze the reasons for zero rejections and identify potential areas for improvement in the application process or regulatory clarity.

Patients

  • Action Item: Advocate for continued transparency and efficiency in the clinical trial approval process to ensure 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 gazette notification regarding rejected clinical trial applications.
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 2022 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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