Regulatory Submission On-Time Rate
Percentage of regulatory dossiers filed to health authorities by the planned submission date
What is Regulatory Submission On-Time Rate?
Regulatory submission on-time rate is the percentage of planned regulatory submissions filed by their target date. It shows how reliably a life sciences company delivers the documents needed to get products approved.
Delays in submissions push back approvals and revenue, so on-time filing is a key measure for regulatory teams.
How this KPI is measured
- Function
- Product & Engineering
- Sub-function
- Regulatory
- Industry
- Pharma & Life Sciences
- Type
- Lagging
- Impact
- Risk
- Unit
- %
- Measurement frequency
- Quarterly
- Formula
- (Submissions filed on time / Total submissions planned) × 100
How to calculate it
Divide submissions filed on time by total submissions planned, and multiply by 100.
For example, if 17 of 20 planned submissions were filed on their target dates, the rate is 85%.
Track the reasons for delay, such as late data or review cycles, and remember that quality of the submission matters as much as timing.
Where it is used
Managing approvals timelines
Keep programmes on plan.
Planning resources
Match teams to workload.
Reporting to leadership
Show regulatory progress.
How to improve it
Tips and common mistakes
- A rushed poor submission can cost more time than a short delay.
- Follow the rules of each regulator.
- Plan for review and response cycles.
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