Registration overview of therapeutic products

  2. Application types

Application types

Understand the different application types that you may use to register your therapeutic product in Singapore.

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:

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

Application TypeConditions
NDA-1For 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.
NDA-2
  • 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.
NDA-3For 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.

* 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.
Application typeConditions
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 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 applications (GDAs) apply to therapeutic products which fall within the descriptions of “generic product” or “standard essential medicine”, as below:

Generic product

A generic product contains 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.

You may register your therapeutic product via GDA if it:

(a)   Has the same pharmaceutical dosage form as the Singapore reference product.
(b)   Has the same administration route as the Singapore reference product.
(c)   Has conditions of use that fall within the directions for use (including indication, dosing regimen and patient group) for the Singapore reference product.
(d)   Is bioequivalent with the Singapore reference product.

Note: Biosimilar or follow-on biologic products are not eligible for a GDA and are required to be submitted as a NDA.

Standard essential medicine

A standard essential medicine contains one or more chemical entities with documented long-standing local clinical use and has a well-established efficacy and safety profile. 

You may register your therapeutic product via GDA if it does not have a corresponding Singapore reference product and it fulfils all of the following criteria:

(a) The therapeutic product is either included on:

  • Ministry of Health (MOH) Standard Drug List (SDL) ; or 
  • A public healthcare institution’s Pharmacy and Therapeutics (P&T) List for a minimum of 5 years prior to the submission of the GDA;
(b) The requested indication(s) must be well-documented in at least one of the listed standard references 1;


(c) The product's quality must comply with:

  • complete monographs for the drug substance and drug product of  recognised pharmacopoeias 2; or
  • complete monograph for the drug substance and minimum monograph requirements of recognised pharmacopoeias accompanied by one of the following:
    • the product is approved and marketed in a reference jurisdiction for at least 5 years continuously prior to the submission of the GDA; or
    • the product is supported by bioequivalence data against a reference product of a reference jurisdiction. 

(d) The product has no known significant safety concerns in global markets; and

(e) The product has not been rejected or withdrawn due to quality, safety and/or efficacy issues by any national regulatory authority.

1. MOH/Agency for Care Effectiveness (ACE) Clinical Practice Guidelines; WHO Model Lists of Essential Medicines; Martindale: The Complete Drug Reference; British National Formulary (BNF); American Hospital Formulary Service (AHFS) Drug Information
2. British Pharmacopoeia; European Pharmacopoeia; US Pharmacopoeia; Japanese Pharmacopoeia.

Note: To submit a GDA for a standard essential medicine, applicants must submit an Expression of Interest form via https://go.gov.sg/standard-essential-medicines at least 3 months before the planned GDA submission date. Applicants may submit the GDA only after receiving HSA’s confirmation in writing that the Expression of Interest has been accepted.

Application TypeConditions
GDA-1 For the first strength of a generic product or standard essential medicine
GDA-2For subsequent strengths of a generic product or standard essential medicine 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.

Please click  here for Common questions related to generic drug applications. 

Refer to Chapter D Generic Drug Application of the Guidance on Therapeutic Product Registration in Singapore for more information.

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