Launch sequence simulator
Explore how market timing and eligible reference approvals change a launch plan.
Plan timing across markets.
Illustrative assumptions · Dates are scenario estimatesIllustrative assumptionsTimeline
Pale span: estimate range · Marker: planning date. Earliest / planning / latest are deterministic scenario bounds, not confidence intervals or observed approval percentiles. Each planned row commits to one route selected by its planning date; all three bounds keep that route. Existing-approval rows preserve the user-entered date, not a regulatory estimate.
United States
Standard NME review · Planned filing:
- Regulatory decision
- 31 Dec 2027 · M1431 Oct 2027 – 30 Apr 2028Official clock + scenario assumptions
- Commercial availability
- Not setNo date estimated
- Reimbursement / access
- Not setNo date estimated
Assumptions & official context
- The US has no single national payer decision. Reimbursement is unknown unless you set an explicit payer-specific scenario assumption.
- Pre-review and additional delays, report availability and post-approval lags are editable scenario assumptions. Commercial supply and effective payer access are separate and need not occur in that order.
- Official clock plus editable planning assumptions. A decision may be negative; plotted approval-dependent access assumes a positive decision.
Read-only milestone summary
All dates and unknowns match the timeline. Ranges are scenario bounds, not confidence intervals.
| Market | Filing / status | Regulatory decision | Commercial availability | Reimbursement / access |
|---|---|---|---|---|
| United StatesStandard NME review | 31 Dec 2027 · M1431 Oct 2027 – 30 Apr 2028Official clock + scenario assumptions | Not setNo date estimated | Not setNo date estimated | |
| JapanStandard new-drug review | 1 Jan 2028 · M141 Nov 2027 – 1 May 2028Official clock + scenario assumptions | Not setNo date estimated | Not setNo date estimated | |
| Mainland ChinaStandard marketing application | 10 Nov 2027 · M12.310 Sept 2027 – 10 Mar 2028Official clock + scenario assumptions | Not setNo date estimated | Not setNo date estimated | |
| SingaporeFull NDA evaluation | 21 Mar 2028 · M16.621 Jan 2028 – 21 Jul 2028Official clock + scenario assumptions | Not setNo date estimated | Not setNo date estimated | |
| AustraliaStandard evaluation | 5 Dec 2027 · M13.120 Sept 2027 – 5 May 2028Official clock + scenario assumptions | Not setNo date estimated | Not setNo date estimated | |
| New ZealandConsent by verification | 27 May 2028 · M18.825 Jan 2028 – 31 Jan 2029Official clock + scenario assumptions | Not setNo date estimated | Not setNo date estimated |
Keep or share this scenario
Method & official sources
Earliest / planning / latest are deterministic scenario bounds, not confidence intervals or observed approval percentiles. Each planned row commits to one route selected by its planning date; all three bounds keep that route. Existing-approval rows preserve the user-entered date, not a regulatory estimate.
The engine selects one route per market using its planning date. It does not find a globally optimal sequence or switch to a new route mid-review.
- Planning scenarios for adult innovative prescription medicines, excluding vaccines, devices, gene/cell/ATMP, blood-derived and personalised products. Local clinical, quality, manufacturing and indication suitability still require confirmation.
- Working days exclude Saturdays and Sundays only. National holidays and exceptional closures are not included; calendar dates may therefore be optimistic.
- All positive-approval and route-eligibility switches are scenario assertions, not regulator confirmations. Review goals are not guaranteed approval dates; refusal, resubmission and development time are not modelled.
- Priority order alone changes no regulatory rule. With a zero resource interval and no explicit filing offsets, reordering only changes display order. Baseline differences reflect assumptions and dependency timing, not a policy change.
- FDAFY 2025 PDUFA Performance Report, pp3 and6: PDUFA VII FY2023–2027 review goalsRead on Atlas · PDFOfficial source ↗Saved copy:
For NME NDAs/original BLAs, review-and-act goals are 10 months standard or 6 months priority after the 60-day filing date, for 90% of a cohort. Action may be approval or a complete response; major amendments can extend goals.
Source context checked: - PMDA
New-drug total application-to-approval targets are 12 months standard and 9 months priority at the 80th percentile of approved items. They include normal applicant response time, have reporting adjustments for busy-period filing and administrative timing, and do not establish a product-specific deadline.
Source context checked: - 国家市场监督管理总局 / NMPA
Formal acceptance is 5 working days; marketing review 200, granted priority 130; administrative decision 20. The special 70-day route is limited to urgently needed, overseas-marketed rare-disease medicines and is not simulated. Applicant supplements and specified activities stop or fall outside clocks; authorized extensions and parallel inspections may matter.
Source context checked: - HSA
Full applies before overseas approval. Abridged requires at least one approval. New-drug verification requires two reference approvals, primary within 3 years, identical quality and full unredacted reports, and no need for local contextual assessment. Japan is not in this reference list. Local and adverse-regulatory-history conditions still apply.
Source context checked: - HSA
NDA screening is 50 working days from dossier receipt; evaluation starts at acceptance: full 270, abridged 180, verification 60 working days. Applicant stop-clock time is excluded. Advance full-route notification and complete paid dossier are assumed ready.
Source context checked: - TGA
The standard evaluation target is 220 working days from acceptance to decision. The statutory 255-day limit is not the planning target; preliminary acceptance and applicant response time are separate. This model adds explicit editable pre-review and interruption assumptions rather than relabelling them as official clocks.
Source context checked: - TGA
The current guidance expressly distinguishes the standard registration 220-working-day planning target from the statutory 255-working-day period, starting at acceptance for evaluation. The provisional route itself is outside this simulator.
Source context checked: - CMS / Medicare
Medicare Part D coverage is provided through approved private plans and each plan may cover different drugs. FDA action does not establish a single national payer-access date; the simulator's payer milestone is unspecified unless the user supplies a scenario.
Source context checked: - TGA
COR-A evaluation/decision is 120 working days: identical medicine/manufacture, full approval no older than one year, and no additional Australian-specific evaluation except label/PI/RMP. COR-B is 175 working days with limited additional evaluation, subject to suitability. Preliminary acceptance is separate.
Source context checked: - TGA
The supported reference subset is US, Japan, Singapore and UK; a country label alone does not establish report or route eligibility.
Source context checked: - Ministry of Health NZ
In force 3 July 2026. Validation: 10 working days after application and validation fee; decision: 30 working days, subject to the Act's fee trigger and stop-clock. Two recognised approvals must each be no older than 4 years; complete assessment reports and identical therapeutic purpose required. Certain child/pregnancy-only, gene and personalised medicines need independent assessment and are out of this model's scope.
Source context checked: - MedsafeVerification Pathway for New Medicine Applications, July 2026, sections 3.1.1, 3.2 and 5Read on Atlas · PDFOfficial source ↗Saved copy:
The recognised subset is US, Australia, UK and Singapore; Japan is absent. COR, IRP and HSA abridged/verification approvals do not count as full evaluations. Initial provisional approvals remain excluded after conversion to full. Validation and application-fee clocks are separate; applicant information requests stop the clock.
Source context checked: - Medsafe
Full NMA targets separate initial evaluation (150 working days) and evaluation of additional information (75). These are not a complete submission-to-consent promise; without a verified end-to-end clock the model returns unknown for the full route.
Source context checked: - MHRA
Innovative applications can reach a positive decision at 150 clock-on calendar days if first-round issues resolve; outstanding issues extend to 210. Starts on the procedure date following validation. Clock-stops, advance notice and monthly scheduling are separate; the model uses 150/210/210 plus explicit pre-review/interruption assumptions.
Source context checked: - MHRA
IRP requires same product, full independent reference assessment and unredacted reports. A: reference approval within 2 years, 60 calendar days from validation; B: within 5 years, 110 days with clock-stops. Route B validation is incorporated in its timetable; A validation is separate. Eligibility triage and national requirements remain, and NAS advance notice is 8 weeks.
Source context checked: - Pharmac
Funding assessment can run alongside Medsafe review. Approval, actual supply and public funding remain distinct milestones; no Pharmac decision duration is inferred here.
Source context checked: