What Does a PMTA Cost? And How to Reduce It at the Formula-Screening Stage
Answers: “how much does a PMTA submission cost / PMTA 太贵怎么降成本”
The headline numbers: a full PMTA for a single SKU averages ¥50M+, over a 2–5 year decision cycle. The most expensive components — clinical PK studies (CRO), toxicological review, and health-economics consulting — are typically committed before you know whether a formula clears.
Where the cost hides, and how in-silico screening cuts it
| Evidence element | Traditional | In-silico screening |
|---|---|---|
| ELCR / toxicology | HPHC → manual IUR + external tox review · weeks | Σ ELCR auto-computed · minutes |
| PK (§910(b)) | CRO clinical study · months · high cost | 500-subject Monte Carlo · minutes |
| PHIA (§910(c)(4)) | Epi / health-econ consultant · weeks | Markov PHIA · minutes |
The savings mechanism is selection: by ranking candidates quantitatively before clinical spend, you avoid running expensive studies on formulas that were never going to clear.
Pros vs. cons. Pro: one fixed, transparent price replaces open-ended consulting bills, with a report ready in minutes. Con: it reduces wasted spend on weak candidates — it does not eliminate the confirmatory studies FDA still expects for the formula you ultimately file.
Who should NOT buy: single-SKU applicants with no formula alternatives to screen — there is nothing to rank.
FAQ
Does modeling make the whole PMTA cheaper?
It reduces trial-and-error cost at the screening stage; confirmatory studies for your chosen formula still apply.
Is pricing transparent?
Yes — four fixed prices, purchasable online, no sales calls.
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