Therapeutic product application types
It is important to identify the appropriate application type for your therapeutic product before using our registration guides to register your product. There are two types of applications for a new product registration:
- New drug application (NDA)
- Generic drug application (GDA)
New drug application
A new drug application (NDA) applies to a therapeutic product that contains new chemical and biological entities. NDA consists of three types:
||For the first strength of a product containing a new chemical or biological entity. This means the entity is currently not a registered entity in Singapore.
- For the first strength of a product containing:
- New combination of registered chemical or biological entities.
- Registered chemical or biological entities in either of the following:
- New dosage form, such as tablets, capsules and injectables.
- New presentation, such as single-dose vials, multi-dose vials and pre-filled syringes.
- New formulation, such as preservative-free.
- Registered chemical or biological entities for use by a new route of administration.
- Registered chemical or biological entities for new indication, dosage recommendation or patient population.
- For products that do not fall under the requirements for NDA-1, NDA-3 or GDA.
||For subsequent strengths of a product that has been registered or has been submitted as a NDA-1 or NDA-2. The product name, dosage form, presentation, indication, dosing regimen and patient population should be the same as that for the NDA-1 or NDA-2 submission.
A biosimilar product applies to a therapeutic product demonstrated to be similar in physicochemical characteristics, biological activity, safety and efficacy to an existing registered biological product. Biosimilar products are required to be submitted via NDA-2 or NDA-3.
For the first strength of a biosimilar product with the same dosage form and route of administration as the Singapore reference biological product.
For subsequent strengths of a biosimilar product that has been registered or has been submitted as an NDA-2. The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-2 submission.
Generic drug application
A generic drug application (GDA) applies to therapeutic products that contain one or more chemical entities and is essentially the same as a current registered product (Singapore Reference Product) in terms of its qualitative and quantitative composition of active ingredients.
Note: Biosimilar or follow-on biologic products are not eligible for a GDA and are required to be submitted as a NDA.
You may register your therapeutic product as a generic drug application if your therapeutic product:
- Has the same pharmaceutical dosage form as the Singapore reference product.
- Has the same administration route as the Singapore reference product.
- Has conditions of use that fall within the directions for use (including indication, dosing regimen and patient group) for the Singapore reference product.
- Is bioequivalent with the Singapore reference product.
||For the first strength of a generic chemical product.
||For subsequent strengths of the generic chemical product that has been registered or submitted as GDA-1. The product name and dosage form should be the same as that for the GDA-1.