Outcome and Implementation plan from the MDA-CAB 2024 Workshop:
- Amendment Phase (April 1, 2024 - April 30, 2024)
- Purpose: Update CAB procedures to align with new templates and processes, make necessary amendments, and conduct internal training.
- Pilot Phase (May 1, 2024 - October 23, 2024)
- Purpose: Test and familiarize with the new GDPMD and Verification Report Templates and TAT, identify potential issues, and gather the feedback.
- Full Implementation Phase November 1, 2024 (Subject to the decision in MDA-CAB Workshop 2024 (Series II) on October 24, 2024
- Purpose: Integrate the GDPMD and Verification Report Templates and TAT into standard operating procedures after thorough testing and refinement.
- Refinement Dates: October 24, 2024 - October 31, 2024
During the pilot phase, the MDA-CAB 2024 Workshop also introduced the Conformity Assessment Report for the product verification route.
References:
IMPLEMENTATION OF MDA-CAB WORKSHOP 2024 OUTCOMES