Home› India› Ministry of Health and Family Welfare› Details of Rejected clinical trial applications / permission...
Date: 2024-01-03 Category: Not Applicable State: Union Government Country: India

Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2023

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

Overview

  • This gazette notification pertains to the details of rejected clinical trial applications and permissions (Form CT-04 and CT-06) for the year 2023.
  • The notification indicates that there were no rejected clinical trial applications or permissions in 2023.

Key Changes

  • There are no changes indicated as the notification explicitly states 'Nil' for all fields, meaning no applications were rejected in the specified period.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Continue to maintain high standards in clinical trial application submissions to avoid rejections in the future. Review internal processes to ensure compliance with regulatory requirements.

Research Institutions

  • Action Item: Maintain current standards of research and application preparation. Share best practices to further improve success rates.

Regulatory Bodies

  • Action Item: Continue to monitor the quality of clinical trial applications and provide guidance to applicants to ensure compliance and reduce potential rejections in subsequent years.

Patients

  • Action Item: No direct action required. Continue to engage with healthcare providers regarding clinical trial opportunities.

Key Entities Referenced

Form CT-04: Application for permission to conduct clinical trial Form CT-06: Application for permission to conduct bioavailability or bioequivalence study 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 2023 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.

Continue your research

Related Documents from Ministry of Health and Family Welfare