REGULATORY AFFAIRS​
Regulatory Process: CDSCO
- Based on the molecule, type of the application will be decided (Subsequent New Drug or Global Clinical Trial)
- Application will be reviewed by drug inspector in first 4 week and prepare summary for expert review
- Subject Expert Committee (SEC) meeting
- Changes in the Regulatory Process since 2013 has resulted in reduced timelines for granting approvals
SEC Meeting Overview
- Submission of application to SEC members by CDSCO along with the summary, and confirmation of adequacy for further review of the application
- SEC members to review and provide feedback in prescribed template in writing through email to CDSCO
- SEC members feedback (in case of queries / clarification / modifications / suggestions) compiled and shared with applicant by CDSCO
- Applicants to respond to SEC members comments
- Presentation to SEC by applicant in post response by applicant (if a response is applicable)
- Applicant response accepted by SEC/CDSCO or if applicants response need further deliberation response put up in immediate next SEC meeting
- Publication of SEC Recommendation on CDSCO website within 3 working days after finalization of minutes
- If accepted by SEC / CDSCO issue of permission by CDSCO
KlinEra Regulatory Process Flow
Initial:
- Preparation of applications to Health Authorities (HAs) to ensure timely submission and approval of clinical trials involving investigational or marketed drugs, devices, biologics, or new medical procedures
- Prepare proposed packaging and labelling to ensure compliance with local regulations
- Register the clinical trial on clinical trial registries, in accordance with local regulatory requirements
- Preparation of CMC modules (small molecules and biologics both) of regulatory applications
- Marketing Authorization and Product Licensing as per HAs
Submission:
- Uploading of application on country specific portals
Query Management:
- Response to query raised by Health Authorities
Post Approval Commitments:
- Submission of documents to fulfil Post Approval Commitments by Health Authorities
Miscellaneous:
- Renewal, Variations and other lifecycle management activities
- Import/Export Management, if applicable