Understanding IND, NDA, and ANDA is very important in Regulatory Affairs and Drug Development, because these applications decide how a drug enters the market.
1) IND (Investigational New Drug)
IND is an application submitted to start clinical trials in humans.
Why IND is needed?
Regulatory authorities must confirm that the drug is:
• Reasonably safe to test in humans
• Scientifically and ethically planned
• Properly manufactured with quality controls
When is IND filed?
Before Phase 1 clinical trials (first time in humans)
What does IND include?
-
Preclinical (Animal) Data
• Pharmacology (how the drug works)
• Toxicology (safety & toxicity studies)
• ADME studies (Absorption, Distribution, Metabolism, Excretion) -
Clinical Trial Protocol
• Study design and objectives
• Inclusion and exclusion criteria
• Dose selection and schedule
• Safety monitoring plan -
CMC (Chemistry, Manufacturing & Controls)
• Drug formulation details
• Manufacturing process
• Stability studies
• Quality testing methods
Goal of IND
To get permission to begin human clinical trials safely.
Example:
A company discovers a new anti-cancer drug →files IND → starts Phase 1.
2) NDA (New Drug Application)
NDA is an application submitted to market and sell a new drug.
When is NDA filed?
After completing: • Phase 1 (Safety & dose range)
• Phase 2 (Efficacy + safety)
• Phase 3 (Large-scale confirmation)
What does NDA include?
-
Clinical Trial Results
• Proof of efficacy (drug works)
• Safety data (side effects, risks)
• Risk vs benefit evaluation -
Drug Labeling Information
• Indication (use)
• Dosage and administration
• Contraindications
• Warnings and precautions
• Adverse reactions -
Manufacturing and Quality Details
• GMP compliance
• Batch consistency
• Stability and shelf-life
• Packaging and storage conditions -
Post-Marketing Safety Plan
• Pharmacovigilance plan
• Risk management plan (RMP) (if required)
Goal of NDA
To get final approval to sell a new drug in the market.
Example:
A new diabetes medicine completes Phase 3 successfully → company files NDA → drug is approved for sale.
3) ANDA (Abbreviated New Drug Application)
ANDA is an application submitted to market a generic drug.
Why is it called “Abbreviated”?
Because the generic company does NOT need: • Full animal studies
• Full Phase 1, Phase 2, Phase 3 trials
Instead, they prove the generic drug is equivalent to the branded drug.
Key requirement in ANDA
Bioequivalence (BE)
This means the generic drug must show:
• Same rate of absorption
• Same extent of absorption
So it gives the same therapeutic effect as the reference product.
What does ANDA include?
-
Bioequivalence Study Data
• AUC, Cmax, Tmax (PK parameters) -
Pharmaceutical Equivalence
• Same active ingredient
• Same strength
• Same dosage form
• Same route of administration -
Quality and Manufacturing Details
• CMC data
• Stability studies
• GMP compliance
Goal of ANDA
To approve a safe, effective, affordable generic drug.
Example:
Brand: Crocin (Paracetamol) → Generic company files ANDA → generic version is approved.
MBH/PS