This gazette notification pertains to rejected clinical trial applications and permissions for the year 2021.
It specifically lists details of applications rejected under Form CT-04 and CT-06.
The provided document indicates that there were no rejected clinical trial applications or permissions in 2021.
Key Changes
There are no changes to report as the gazette indicates zero rejected clinical trial applications or permissions in 2021. The listed details are 'Nil' for all fields including File No., Firm Name, Name of Product, Phase of the study, Title of Application/Permission No., Date of Rejection, and Summary.
Impact Analysis
Pharmaceutical Companies
Action Items: Continue to maintain high standards in clinical trial application submissions to avoid future rejections. Analyze application processes to identify areas of improvement.
Regulatory Bodies
Action Items: Continue to monitor the quality and completeness of clinical trial applications. Analyze the reasons for rejection in previous years to identify trends and provide guidance to pharmaceutical companies.
Patients
Action Items: Advocate for transparency and efficiency in the clinical trial approval process to ensure timely access to innovative treatments.
Research Institutions
Action Items: Maintain rigorous research standards and collaborate with pharmaceutical companies to ensure compliance with regulatory requirements.
Key Entities Referenced
Form CT-04: Application form for permission to conduct clinical trial.
Form CT-06: Application form for seeking permission for subsequent new drug approval.
QMS-GNL-019/F02(b)-00: Format number for the document.
Annexure - II(b)
Details of rejected clinical trial applications / permissions (Form CT-04 and CT-06)
Year 2021
S. File Firm Name of Phase Title of Application Date of Summary
No. 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.