The NDA Verification Evaluation Route pathway has been developed by the Health Sciences Authority of Singapore.
This pathway can be used where Applicants can submit an NDA to register their therapeutic product via the verification evaluation route if it: (i) has been approved by at least two of HSA's reference drug regulatory agencies at the time of submission; (ii) has been approved within three years by the chosen primary reference agency; (iii) has a declaration letter issued by the product owner/applicant must be provided stating that all aspects of the drug product’s quality, including but not limited to the formulation, manufacturing site(s), release and shelf life specifications and primary packaging, are identical to that currently approved by the chosen primary reference agency at the time of submission. However, a different container closure system type (e.g. Alu/Alu blister vs. HDPE bottle) may be proposed to meet ASEAN stability requirements. Unredacted and unedited assessment reports and supporting documents from the chosen primary reference agency must also be submitted (this is compulsory); (iv) does not need a more stringent assessment due to differences in local disease patterns or medical practices; (v) has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons; and (vi) is not a biological product. If a Drug Master File is submitted, then a separate declaration letter issued by the applicant must also be provided to state that the DMF submitted to HSA is identical to that submitted to the chosen primary reference agency. NDA-3 applications: Applicants may register the subsequent strength of a currently-registered therapeutic product as an NDA-3 via the verification evaluation route under one of the following conditions: (i) Has been evaluated and approved by only one of HSA's reference drug regulatory agencies, the NDA-3 must be submitted within two years from the date of approval of that reference drug regulatory agency; (ii) Has been evaluated and approved by at least two of HSA's reference drug regulatory agencies, the NDA-3 must be submitted within three years from the date of approval by the chosen primary reference agency. NB: The proposed indication, dosing regimen, patient group, and direction for use must be identical to the corresponding approved NDA-1 and NDA-2 products. The proposed PI/PIL are consistent with that currently approved for the corresponding NDA-1 and NDA-2 products. .
This pathway accelerates the regulatory review process.
When relevant, the agency relies on prior decisions from Australia Canada EU-EMA United Kingdom United States
Screening (in working days) = 50. Evaluation (in working days) = 60. 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.