Screening, evaluation and regulatory decision
Understand the application screening and evaluation process leading to regulatory decisions.
Last updated 2 April 2026
Screening stage
Application screening involves us checking that the application type is correct and that the dossier is complete. The screening timeline starts from the date of receipt of the application dossier.
Screening will not commence if:
The entire dossier sections are not submitted.
The submitted dossier does not comply with either the ICH CTD or ACTD format.
Input request(s) will be sent to the applicant if clarification or additional information is required. The applicant will be given 20 working days to respond to each input request. The application will be put on a stop-clock, starting from the date of input request until the date of receipt of a complete and satisfactory response to the query.
Screening input requests will generally be capped at two cycles.
Failure to address the deficiencies raised during screening will render the dossier incomplete for evaluation. Applicants will be requested to withdraw the application. Future submission will be processed as a new application.
Screening fees paid are non-refundable.
If your application is identified to be more appropriately submitted under a different application type, you will be informed to change via an input request.
The screening process only checks for completeness of the application dossier for evaluation. The acceptance of the dossier for evaluation does not constitute the adequacy of the data for regulatory approval.
Evaluation stage
If the dossier is screened to be complete for evaluation, an acceptance notice will be issued, marking the start of the evaluation timeline. The evaluation stage ends when a regulatory decision is issued.
Input request(s) will be sent to the applicant if clarification or additional information is required. The applicant will be given 20 working days to respond to each input request. The application will be put on a stop-clock, starting from the date of input request until the date of receipt of a complete and satisfactory response to the query.
Applicants are reminded that the submission of additional supporting data not requested by HSA following the acceptance of the application will not be considered in the evaluation.
Regulatory decision
You will be notified of the regulatory decision after evaluation:
Approval
An approval decision means the application satisfies the registration requirements for quality, safety and efficacy.
The product will be added to the Register of Class 2 CTGTP (opens in new tab). As the CTGTP registrant, you are responsible for ensuring the CTGTP's quality, efficacy and safety throughout its life cycle, and must notify us of any changes to these profiles.
Rejection
A rejection decision means your response failed to address the major deficiencies specified in the non-approvable notice. A rejection decision is final.