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Application Timeline Calculator

Estimate the key milestone timelines of your therapeutic product registration and major variation applications. 

This calculator enables you to estimate the first evaluation input request (IR) and regulatory outcome dates of new product and major variation applications to facilitate submission planning and management. These key milestone dates are calculated based on working days (WD) and the respective application target turnaround times (see HSA | Fees and turnaround time for therapeutic products). This tool estimates the evaluation timeline and does not include the screening process.

 Note:

  • Dates provided are intended as an estimate only based on the information you have provided. 
  • The actual application timeline may differ as this is contingent on the quality of your submission, the rounds of IR and the timeliness in your response to evaluation IRs. Please adhere to due dates for IRs and ensure that submitted responses are complete.
  • Submission of datasets of good quality is encouraged as this minimises the need for multiple rounds of IRs and makes the review process more efficient.  As a general guide, applicants should address all evaluation queries within 3 rounds of IR. An applicant may be required to withdraw the application if it fails to satisfactorily respond to evaluation queries after multiple rounds of IR.