The NDA Abridged Route pathway has been developed by the Health Sciences Authority of Singapore.
This pathway can be used where This procedure is for new drug applications for products containing new chemical and biological entities. APPLICATION TYPES - NDA (New Drug Application) | NDA-1: For the first strength of a product containing a new chemical or biological entity. NDA-2: (a) For the first strength of a product (i) containing a new combination of registered chemical or biological entities; (ii) containing registered chemical or biological entity(ies) in a new dosage form (e.g. tablets, capsules, injectables), new presentation (e.g. single-dose vials, multi-dose vials, pre-filled syringe, starter packs), or new formulation (e.g. preservative-free); (iii) containing registered chemical or biological entity(ies) for use by a new route of administration; or (iv) containing registered chemical or biological entity(ies) for new indication(s), dosage recommendation(s) and/or patient population(s). (b) For products that do not fall under the descriptions for NDA-1, NDA-3 or GDA. NDA-3: For subsequent strength(s) of a product that has been registered or has been submitted as an NDA-1 or NDA-2. The product name, active ingredient, dosage form, presentation, indication, dosing regimen and patient population should be the same as that for the NDA-1 or NDA-2. PRIORITY REVIEW - For NDAs submitted via the abridged evaluation route, the applicant may request for priority review for a life-saving drug if there are unmet medical needs. The following are the criteria that will be considered for granting a priority review: (a) The drug is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address local unmet medical needs, as defined by: (i) the absence of a treatment option; or (ii) the lack of safe and effective alternative treatments, such that the drug would be a significant improvement compared to available marketed products, as demonstrated by (A) evidence of increased effectiveness in treatment, prevention, or diagnosis; or (B) elimination or a substantial reduction of a treatment-limiting drug reaction. (b) Disease conditions that are of local public health concern will be given primary consideration for priority review. Currently these include: (i) cancer; and (ii) infectious diseases: dengue, tuberculosis, hepatitis and malaria. The request for priority review should be made at the point of the application submission and accompanied by justifications for requesting for a priority review and how the product is expected to benefit patients. HSA reserves the right to deny a request for priority review if it is deemed appropriate. The decision for the granting of priority review would be conveyed to the applicant at the point of acceptance of the application for evaluation..
This pathway accelerates the regulatory review process.
Screening (in working days) = 50. Evaluation (in working days) = 180. 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 the queries is incomplete, and the applicant is required to provide further clarification or additional information.