Are Biologics Always NDA-1 in Singapore? A Guide to Regulatory Categories

When companies prepare to register biologic products in Singapore, there’s a common assumption that all biologics must go through the NDA-1 route. But that’s not always the case.

Understanding Singapore’s NDA-1, NDA-2, and NDA-3 categories — and which applies to your product — is key to smooth regulatory submissions and avoiding unexpected delays.

NDA-1: New Biological Active Substance
Under HSA’s framework, NDA-1 applies when the product contains a new chemical or biological active substance that has never been registered in Singapore. This typically includes:

Innovative biologics
First-in-class monoclonal antibodies
New gene or cell therapy products
Novel vaccines

These applications require full safety, efficacy, and quality data, and undergo a thorough scientific review, often with longer evaluation timelines.

NDA-2: New Dosage Form, Strength, Route, or Formulation
NDA-2 covers new dosage forms, strengths, administration routes, or formulations of an already-registered active substance. Examples include:

A subcutaneous version of an approved IV monoclonal antibody
A prefilled syringe instead of a vial
A biosimilar referencing a biologic already registered in Singapore

Many biosimilars fall under NDA-2 when referencing a Singapore-registered originator. This means no new active substance is introduced, but bridging and comparative studies (analytical, PK/PD, sometimes clinical) are required. If the reference product isn’t registered locally, the biosimilar may be up-classified to NDA-1.

NDA-3: Subsequent Strength(s) of Registered Product
NDA-3 applies to additional strengths of products already registered or submitted as NDA-1 or NDA-2. The new strength must have the same product name, active ingredient, dosage form, presentation, indication, dosing regimen, and patient population as the original.
Examples include introducing a 50 mg vial after registering a 25 mg vial of the same biologic. Data requirements are usually limited to bridging information.

Why is this important?
Misclassifying your NDA category can cause delays, extra data requests, or even rejection at screening. Knowing the right NDA pathway helps you plan better and work smoothly with HSA.

Navigating Singapore’s regulatory pathways takes experience and understanding of local requirements. Whether you’re registering an innovative biologic, a biosimilar, or new strengths and formulations, it’s important to:

Accurately classify your NDA category
Understand HSA’s data and documentation expectations
Strategically plan your submission for efficiency

As a regulatory consultant, I work closely with clients to simplify these complexities and help prepare submissions that meet HSA requirements. Feel free to reach out if you need support. Wishing you all the best in your regulatory journey!

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