2. 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

A new drug application (NDA) applies to a therapeutic product that contains new chemical and biological entities. NDA consists of three types:

* i.e. not a chemical or biological entity that is either registered or being concurrently submitted for registration in Singapore. Currently registered therapeutic products can be found in the Register of Therapeutic Products.

Biosimilar products

You may be eligible to register your therapeutic product as a biosimilar product if it is a biological therapeutic product that is similar to an existing biological product registered in Singapore (Singapore reference biological product) in terms of physicochemical characteristics, biological activity, safety and efficacy.

Eligibility

Your product should fulfil the following criteria in order to qualify as a biosimilar product:

• Comprehensive comparability exercise done with SRBP. A registered biosimilar product cannot be used as a reference product. A biological product with no suitable SRBP will not qualify for registration as a biosimilar product in Singapore.

• If the comparative studies are performed with a reference product from a non-Singapore registered manufacturing source, additional bridging studies may be required to demonstrate that the reference product is comparable to the SRBP.

• The active ingredients of the biosimilar product and the SRBP should be similar in molecular and biological terms.

• The pharmaceutical form, strength and route of administration of the biosimilar product should be the same as the SRBP. Any differences will have to be justified by appropriate studies.

• The conditions of use for the biosimilar product must fall within the directions for use (including indications, dosing regimens and patient groups) of the SRBP.

• The product must be approved by at least one of the following reference drug regulatory agencies: EU EMA, Australia TGA, UK MHRA, US FDA and Health Canada. If not, you need to submit the application for a new biological product with the complete dataset.

Please click here for Common questions related to Biosimilar applications. Search our Register of Therapeutic Products to identify the SRBP.

A biosimilar product application is eligible for the NDA abridged or verification route. There are two types of applications for biosimilar products:

• NDA-2: For the first strength of a biosimilar product with the same dosage form and route of administration as the Singapore reference biological product.

• NDA-3: For subsequent strengths of a biosimilar product that has been registered or 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.

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.

Please click here for Common questions related to generic drug applications. Search our Register of Therapeutic Products to identify the SRP.

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Evaluation Routes