February 13, 2026

Navigating pharmaceutical regulatory pathways is fundamental for drug development, global approvals, and lifecycle compliance. Every medicinal product whether innovator drug, generic medicine, or API must pass through specific regulatory submission routes defined by agencies like US FDA, EMA, CDSCO, PMDA, MHRA, and Health Canada.

Understanding the difference between IND, NDA, ANDA, DMF, and CTD/eCTD is critical for ensuring regulatory approval success, compliance readiness, and reduced review queries.

This guide from Maven Regulatory Solutions breaks down each submission type using both technical accuracy and practical regulatory insight.

Why Regulatory Submissions Matter

Regulatory dossiers provide evidence that a drug is:

  • Safe
  • Effective
  • High quality
  • Manufactured under GMP
  • Properly labeled for patient use

Strong submissions reduce regulatory review cycles, deficiency letters, and approval delays.

Key Types of Pharmaceutical Regulatory Submissions

Submission Type

Purpose

Stage of Drug Lifecycle

Key Technical Focus

IND

Approval to begin human trials

Pre-clinical → Clinical

Safety, pharmacology, CMC

NDA

Marketing approval for new drug

Post clinical trials

Full safety & efficacy data

ANDA

Approval for generic drugs

Post innovator approval

Bioequivalence, CMC

DMF

Confidential manufacturing data

Supports NDA/ANDA

API, excipients, packaging

CTD/eCTD

Standard submission format

All stages

Structured global dossier

1. IND — Investigational New Drug Application

The IND submission is required before initiating clinical trials in humans in the United States.

Regulatory Objective

Ensures that the investigational product does not expose trial subjects to unreasonable risk.

Core IND Components

  • Preclinical pharmacology & toxicology
  • CMC (Chemistry, Manufacturing, Controls)
  • Clinical trial protocols
  • Investigator information

2. NDA — New Drug Application

An NDA requests FDA approval to market a new pharmaceutical product.

Includes

  • Clinical trial data (Phase I–III)
  • Risk–benefit evaluation
  • Stability data
  • Labeling & prescribing information
  • Manufacturing validation

3. ANDA — Abbreviated New Drug Application

Used for generic drug approval.

Primary Focus

  • Demonstration of bioequivalence
  • Same dosage form, strength, and route as RLD
  • No need for full clinical efficacy trials

4. DMF — Drug Master File

A DMF provides confidential data about:

  • Active Pharmaceutical Ingredients (API)
  • Excipients
  • Packaging materials
  • Manufacturing processes

Supports multiple NDAs/ANDAs without revealing proprietary data.

5. CTD / eCTD Format

The Common Technical Document (CTD) standardizes global submissions.

5 CTD Modules

Module

Content

1

Regional administrative info

2

Summaries & overviews

3

Quality (CMC)

4

Non-clinical studies

5

Clinical studies

eCTD is the electronic submission format required by most health authorities.

2026 Pharmaceutical Regulatory Trends

  • AI-assisted dossier authoring
  • eCTD v4.0 adoption
  • Increased focus on data integrity
  • Digital submission portals modernization
  • Global harmonization under ICH guidelines

How Maven Regulatory Solutions Supports

Maven provides:

  • Regulatory strategy planning
  • IND/NDA/ANDA dossier preparation
  • DMF compilation & lifecycle maintenance
  • eCTD publishing & validation
  • Global health authority submission support

FAQs

Q1. Is CTD mandatory worldwide?
Yes, most global agencies follow CTD structure.

Q2. Can one DMF support multiple applications?
Yes, it can support several NDAs/ANDAs.

Q3. Does ANDA require clinical trials?
Only bioequivalence studies, not full clinical efficacy trials.