The Verification - CECA Route pathway has been developed by the Health Sciences Authority of Singapore.
This pathway can be used where Applicants may register their generic drug via the verification evaluation route if it meets the following criteria: (i) Has been approved by at least one of HSA's reference drug regulatory agencies at the time of submission; (ii) Has been approved within two years by the chosen reference agency; (iii) Has a declaration letter by the product owner or applicant stating that all aspects of the product’s quality are identical to that currently approved by the chosen reference agency. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen reference agency; (iv) Has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons; and (v) The approval from the chosen reference drug reference agency was not obtained via an accelerated/fast-track approval or approval under exceptional circumstances. Note: If a drug master file (DMF) is submitted, applicants must submit the unredacted and unedited assessment reports for the DMF and provide a separate declaration stating that the DMF they submitted is identical to the one submitted to the chosen reference agency..
When relevant, the agency relies on prior decisions from Australia Canada EU-EMA United Kingdom United States
Screening (in working days) = 50. First Communication (in working days) = 14. Evaluation (in working days) = 90. 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 responses to HSA's queries are incomplete, and applicants are required to provide further clarification or additional information.