PAS-vs-Internal Change Savings Calculator
Size the return on moving post-approval changes down the reporting hierarchy — from a prior-approval supplement toward a notification or internal management under ICH Q12 Established Conditions and a pre-agreed PACMP. Estimates the filing cost avoided and the delay value released (months → weeks) across your change portfolio. A business-case aid, not a validated system.
OUTPUT
TIME
Limitations — read before you rely on this
- This is a business-case aid, not a validated system, and its output is a planning estimate rather than a regulatory or accounting figure. Reproduce the arithmetic in your own model before it supports a decision — the formula and the category defaults are published above so you can.
- The reporting-category defaults are illustrative planning figures, not the fee or timeline any authority guarantees. The actual downgrade available for a specific change depends on the approved Established Conditions and the assessed risk — the tool cannot tell you which changes qualify.
- The delay value is opportunity cost, real only if the change improves throughput or margin. For a like-for-like change with no output effect, set margin per day to zero and the case rests on filing cost alone.
- It models one current-and-target path applied uniformly. A portfolio spanning several categories needs the calculation run per cohort, not averaged.
WHAT THIS CALCULATES
The annual money and time a mature quality system releases by moving post-approval changes down the reporting hierarchy — from a prior-approval supplement toward a notification or management inside the PQS, which is the flexibility ICH Q12 gives an enhanced-approach product. It sizes two returns a business case must keep apart: the regulatory filing cost avoided, and the value of the review time no longer spent waiting.
THE METHOD
AnnualSavings = changes × [ markets×(PAS_cost − target_cost) + (lead_current − lead_target)×margin_day − PQS_cost ]- changes
- post-approval changes in the annual portfolio being re-classified
- markets
- markets each change must be filed in — filing cost scales with this
- PAS_cost
- regulatory/submission cost per change on the current path, per market
- target_cost
- submission cost per change on the target path, per market (0 if managed internally)
- lead_current
- submit-to-effect lead time on the current path, in days
- lead_target
- submit-to-effect lead time on the target path, in days
- margin_day
- value per day of having the change in effect — yield, capacity, or margin attributable
- PQS_cost
- internal cost per change to execute and document it under the enhanced approach
The reporting-category defaults behind each dropdown (PAS ≈ $80k/180 days, CBE-30 ≈ $25k/30 days, and so on) are order-of-magnitude planning figures, not regulatory values — every one is editable. The delay term is opportunity value, so it is only real to the extent the change actually improves throughput or margin.
THE INPUTS, AND WHAT THEY MEAN
- Changes per year
- The count of post-approval changes you expect to re-classify under the enhanced approach — scope it to one product or facility so the filing costs and lead times stay coherent.
- Markets per change
- How many health authorities each change is filed with. A single change filed in ten markets multiplies the filing saving by ten, which is where most of the number often comes from.
- Current / target reporting category
- Where the change sits today and where an Established Condition plus PACMP would let it sit. Picking a category pre-fills the filing cost and lead time, both of which you then correct to your own figures.
- Margin per day attributable
- The daily value of having the change live — added yield, freed capacity, or margin. This is what turns "months faster" into money, and it is zero for a change that does not affect output.
- Internal PQS cost per change
- What it costs you to execute and document a change internally under the enhanced approach — the assessment, the records, the effectiveness check. It is netted off the saving so the tool never flatters the case.
Size the return on filing a change lower — or managing it internally.
A mature PQS earns the right to move post-approval changes down the reporting hierarchy under ICH Q12 Established Conditions and a pre-agreed PACMP. Enter your change portfolio to size two returns at once: the regulatory filing cost avoided, and the delay value released when a change stops waiting months for approval. A business-case aid, not a validated system.
Picking a category pre-fills the filing cost and lead time with a planning default — override both with your own figures. All figures stay in your browser.
HOW TO READ THE OUTPUT
- The output is an order-of-magnitude planning estimate for a portfolio conversation, not a filing-by-filing forecast. Its job is to show whether earning Q12 flexibility is worth six or seven figures a year before anyone builds a detailed model.
- Filing savings are near-certain; the delay value is the softer half and depends entirely on whether the change improves throughput. Present the two separately and let the filing saving carry the conservative case.
- The lead-time delta is the strategic number: the "months → weeks" acceleration is often worth more than the filing fee, especially for a capacity or yield change on a supply-constrained product.
- A negative net per change is a real and useful result — it says the internal PQS burden exceeds what the downgrade returns for that change, so it is not a candidate for the enhanced approach.
WORKED EXAMPLE
A product with 12 post-approval changes a year, each currently a PAS filed in one market ($80k, 180-day lead), moving to internal management under an Established Condition + PACMP. Margin attributable is $5,000/day; internal PQS cost is $15,000/change.
- Changes / year
- 12
- Current path
- PAS — $80,000/market, 180 days
- Target path
- Managed internally — $0, 10 days
- Margin / day
- $5,000
- Internal PQS cost / change
- $15,000
RESULT
Of the $915k per change, the filing fee is only $80k — the delay value ($850k, from 170 days at $5,000/day) dominates. That reframes the whole case: this is not a submissions-cost saving, it is a speed-to-effect saving, and it is only that large because the change genuinely earns $5,000/day once live. Halve that margin assumption and the case still clears $5M.
REGULATORY BASIS
- ICH Q12 — Technical and Regulatory Considerations for Lifecycle Management
- Establishes Established Conditions and the PACMP, the mechanisms by which a mature PQS can lower the reporting category of a defined post-approval change.
- ICH Q10 — Pharmaceutical Quality System
- The effective PQS and change-management system that Q12 flexibility is conditional on; the internal-cost input represents this machinery doing the work a submission used to.