Regulatory Reference
Regulatory Pathway Finder
Match your product type to the likely FDA and EMA approval pathway — from IND through NDA, ANDA, BLA, or biosimilar routes, including expedited designations.
Pathway by product type
| Product type | FDA pathway | EMA pathway | Key evidence |
|---|---|---|---|
| New chemical entity (NCE) | IND → NDA (505(b)(1)) | Centralized (often mandatory) or MRP/DCP | Full clinical efficacy & safety |
| New formulation / indication (known API) | IND → 505(b)(2) NDA | Line extension; centralized or national | Bridging PK + selective clinical data |
| Generic small molecule | ANDA (505(j)) | Generic application (national/MRP) | Bioequivalence vs reference |
| Original biologic | IND → BLA (351(a)) | Centralized BLA-style MA | Full clinical + process characterization |
| Biosimilar | 351(k) BLA | Biosimilar MA (comparability exercise) | Analytical + PK/PD + clinical similarity |
| Fixed-dose combination (approved APIs) | NDA or 505(b)(2) | Art 10(3) hybrid or new application | Combination justification + BE/PK |
FDA expedited programs
- Fast Track — serious condition, unmet need; rolling review possible
- Breakthrough Therapy — preliminary clinical evidence of substantial improvement
- Priority Review — 6-month PDUFA goal (assigned at filing)
- Accelerated Approval — surrogate/ intermediate endpoint with confirmatory commitments
- Orphan Drug — incentives for rare diseases (<200,000 US patients)
EMA procedure types
| Procedure | When used |
|---|---|
| Centralized | Mandatory for many biotech/oncology/HIV products; single EU-wide MA |
| Decentralized (DCP) | New product not yet in any MS; one RMS leads mutual recognition |
| Mutual Recognition (MRP) | Product already authorized in one MS; extend to others |
| National | Single member state only (localized products) |
PRIME (Priority Medicines) is EMA's early engagement scheme analogous to FDA breakthrough — for medicines targeting high unmet need.
Typical sequence
For a new US/EU product:
- Pre-IND / Scientific Advice (FDA / EMA)
- IND or CTA filing → Phase I–III clinical program
- Pre-NDA/BLA or pre-MA meeting
- eCTD submission (Module 1–5) → review → approval
- Post-marketing pharmacovigilance and variations
Frequently asked questions
Use 505(b)(2) when you can rely on FDA's prior findings or published literature for part of the
safety/efficacy package (new formulation, route, or indication of a known drug). Use 505(b)(1)
for a new molecular entity requiring a full independent clinical package.
No — but it is mandatory for certain categories (e.g. biotech, orphan, HIV, oncology, diabetes
therapies per EU rules). Many conventional small molecules use DCP/MRP or national routes.