# Regulatory Timelines by Agency

Reference for setting expectations when estimating approval milestones or
identifying gaps between submission and approval in different markets.

---

## Standard Review Timelines

| Agency | Review Type | Clock (months) | Notes |
|--------|-------------|----------------|-------|
| **FDA** | Standard NDA/BLA | 12 | From submission (PDUFA date) |
| **FDA** | Priority Review | 6 | Priority designation required |
| **FDA** | Breakthrough Therapy | 6 (priority clock) | + intensive guidance |
| **FDA** | Accelerated Approval | Variable | Based on surrogate endpoint |
| **EMA** | Centralized Standard | 210 days (+clock stops) | Typically 12–15 months total |
| **EMA** | PRIME (accelerated) | 150 days active | Early interaction program |
| **EMA** | Conditional MA | Faster | Post-marketing obligations |
| **PMDA** | Standard | 12 | From filing date |
| **PMDA** | Priority Review | 9 | Serious/unmet need |
| **CDE/NMPA** | Standard NDA | 12–18 | Clock starts at acceptance |
| **CDE/NMPA** | Priority Review | 6 | National urgent need |
| **CDE/NMPA** | Conditional Approval | Variable | Post-marketing required |
| **MFDS** | Standard | 12 | From submission acceptance |
| **MFDS** | Fast Track | 6 | Serious/life-threatening |
| **TGA** | Standard | 12 months | From submission |
| **TGA** | Priority | 6 months | Life-threatening conditions |
| **MHRA** | Standard | 150 days | Post-Brexit, UK only |
| **MHRA** | Innovative Licensing | Variable | ILAP pathway |

---

## Key Regulatory Milestones (US / FDA)

```
Pre-IND meeting
IND submission → 30-day FDA review (clinical hold or proceed)
Phase 1 → Phase 2 → Phase 3 (typical; may compress)
End of Phase 2 meeting (Type B)
Pre-NDA/BLA meeting (Type B)
NDA/BLA submission (eCTD format)
  → Day 60: Filing/Refuse to File decision
  → Advisory Committee meeting (if convened)
  → Day 180: Mid-cycle review
  → PDUFA date: Action (Approval / CRL / Complete Response Letter)
Post-approval: REMS (if required), label negotiations, manufacturing inspections
```

## Key Regulatory Milestones (China / CDE-NMPA)

```
IND application → CDE review (60 working days default)
Clinical trial authorization (CTA)
  → Phase I (first-in-human): often at dedicated CROs in CN
  → Phase II/III: registration trials
Pre-NDA communication meeting (沟通交流会)
NDA submission (申请上市许可)
  → Acceptance and assignment
  → Technical review (技术审评)
  → On-site inspection (核查)
  → NMPA approval (批准上市)
Priority Review (优先审评审批): 6-month target
Conditional Approval (附条件批准): post-marketing studies required
NRDL listing negotiation (国家医保目录谈判): pricing/reimbursement after approval
```

## Key Regulatory Milestones (Japan / PMDA)

```
Pre-consultation (事前相談)
Clinical trial notification (治験届) — mandatory 30 days before Phase 1
Phase I → II → III
New Drug Application (新薬承認申請 / J-NDA)
  → PMDA review + inspection
  → MHLW approval (承認)
  → NHI price listing (薬価収載) — typically 60–90 days post-approval
  → Market launch
```

---

## Expedited Pathways Comparison

| Feature | FDA | EMA | PMDA | CDE/NMPA | MFDS |
|---------|-----|-----|------|----------|------|
| Fast Track | ✓ | — | ✓ (優先審査) | ✓ (优先审评) | ✓ |
| Breakthrough Therapy | ✓ | — | — | ✓ (突破性治疗) | — |
| Accelerated Approval | ✓ | Conditional MA | ✓ | Conditional (附条件) | ✓ |
| Priority Medicines | — | PRIME | — | — | — |
| Orphan Drug | ✓ | ✓ | ✓ | ✓ (2020+) | ✓ |
| Pediatric Priority | ✓ | PUMA | ✓ | ✓ | — |
| Rolling Review | ✓ | ✓ (COVID era) | ✓ | ✓ | ✓ |

---

## Typical Lag: US Approval → Ex-US Approval

Based on historical patterns for innovative drugs (oncology/rare disease):

| Market | Median Lag vs FDA | Notes |
|--------|-------------------|-------|
| EU (EMA) | 6–18 months | May co-develop; sometimes simultaneous |
| Japan (PMDA) | 12–24 months | "Drug lag" historically; improving |
| China (NMPA) | 12–36 months (shrinking) | Domestic innovation approvals now often faster |
| Korea (MFDS) | 12–24 months | Often follows US/EU data |
| Australia (TGA) | 6–18 months | Sometimes faster than EU |

> Since ~2018, China's CDE reform has dramatically shortened this lag for priority drugs.
> Monitor domestic CN-first approvals (e.g., EGFR, ALK inhibitors) where China may approve ahead of or concurrently with FDA.

---

## Data Exclusivity Periods by Region

| Region | NCE Exclusivity | Biologic Exclusivity | Orphan |
|--------|----------------|----------------------|--------|
| US | 5 years | 12 years | 7 years |
| EU | 8+2(+1) years | 10 years | 10 years |
| Japan | 8 years | 10 years | 10 years |
| China | Not yet harmonized | Limited framework | 7 years (pilot) |
| Korea | 6 years | — | 10 years |
| Australia | 5 years | 5 years | 5 years |

> "8+2+1" EU formula: 8 yr data exclusivity + 2 yr market exclusivity + 1 yr new indication.
> CN data exclusivity rules are evolving post-TRIPS Agreement implementation.