Home› India› Ministry of Health and Family Welfare› Details of Rejected clinical trial applications / permission...
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) 2020

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, specifically Form CT-04 and CT-06, for the year 2020.
  • The notification indicates that there were no rejected clinical trial applications or permissions (Form CT-04 and CT-06) in the year 2020.

Key Changes

  • The gazette explicitly states 'Nil' for all fields, including File No., Firm Name, Name of Product, Phase of the study, Title of Application/Permission No., and Date of Rejection.
  • This signifies that zero applications under Form CT-04 and CT-06 were rejected in 2020.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Analyze the number of clinical trial applications submitted in 2020 compared to previous years to understand the context of the 'Nil' rejection rate. Investigate reasons for a potential decrease in application submissions.

Clinical Research Organizations (CROs)

  • Action Item: Review internal processes for clinical trial application preparation to identify best practices that contributed to the zero rejection rate.

Regulatory Authorities

  • Action Item: Evaluate the clinical trial application review process to confirm its effectiveness and identify areas for further improvement.

Patients

  • Action Item: None

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, likely referring to the document control system within the regulatory authority.
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 2020 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