As we progress towards implementing reliance throughout the product life cycle, we plan to expand the implementation of reliance to include new/additional indication applications beginning with a pilot project.
For this pilot project, we have revised the current categories and their criteria as in Appendix I. The pilot study, with a duration of 12 months, will be conducted starting on August 1, 2024.
As this is a pilot project, the proposed estimated timeline for AI reliance as in Appendix I represents the best commitment NPRA can make under the current circumstances to test out new processes and requirements. In addition to the AI applications, we are handling a high volume of variation applications, all with the same staff and resources.
As you may be aware, we are also working to streamline the variation process. We appreciate applicants’ cooperation and support in this pilot project, and we seek your assistance in properly planning and scheduling your variation submissions. This may help reduce our workload and consequently improve the timeline for new AI applications.
Applicants are advised to consult the respective head of sections if there are any queries.
Related documents:
(1) Appendix I
