Snapshot

The GDA Abridged Route pathway has been developed by the Health Sciences Authority of Singapore.

This pathway can be used where There are two application types for a generic drug application: GDA (Generic Drug Application) | GDA-1: For the first strength of a generic chemical product. GDA-2: For subsequent strength(s) 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. In cases where multiple strengths of a generic product are submitted together, the strength of the product used in the BE study is considered as a GDA-1. The remaining strength(s) should be submitted as GDA-2. Generic Product - A generic product must have the same qualitative and quantitative composition in active substances and be of the same pharmaceutical form as a currently registered product in Singapore (known as the ‘Singapore reference product’). A generic product must demonstrate bioequivalence to the Singapore reference product via appropriate bioequivalence studies. The generic product must fulfil the following criteria: (a) the generic product is the same pharmaceutical dosage form as the Singapore reference product. However, different conventional oral immediate-release dosage forms (i.e. tablets and capsules) are considered to be the same pharmaceutical form; (b) the route of administration of the generic product is the same as the Singapore reference product; (c) the conditions of use for the generic product fall within the directions for use (including indication(s), dosing regimen(s) and patient group(s)) for the Singapore reference product; and (d) the generic product is bioequivalent with the Singapore reference product. Singapore Reference Product - The Singapore reference product must be a currently registered product that has been granted market authorisation based on the evaluation of the product’s quality, efficacy and safety – i.e. a dossier with chemical, biological, pharmaceutical, pharmacological-toxicological and clinical data. If such a reference product is not registered in Singapore, then an alternate registered comparator product may be used if adequately justified (e.g. a registered generic therapeutic product widely used by local hospitals) by the applicant and agreed upon by HSA. The generic product should contain the same active substance(s) and strength(s) and be the same pharmaceutical dosage form as the Singapore reference product. For generic products containing a different salt, ester, ether, isomer, mixture of isomer, complex or derivative of the active substance compared to the Singapore reference product, applicants are required to submit data to demonstrate that the different form does not differ from the active substance in the Singapore reference product in terms of safety and/or efficacy..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Screening (in working days) = 50. Evaluation (in working days) = 240. Note: (i) Screening turnaround time begins from the date of receipt of application dossier; (ii) Evaluation turnaround time begins from the date of acceptance for evaluation; (iii) Turnaround time may be extended if the applicant's response to HSA's queries are incomplete, and applicants are required to provide further clarification or additional information.