Application screening
The following documents must be submitted before screening may proceed:
- Entire dossier sections
- Drug Master file (if applicable)
- A copy of email acknowledgment from HSA on the receipt of the Letter of Access for applications supported by DMF (if applicable)
- Application checklist in MS Word (Appendix 2 or 3)
- Assessment reports (for verification route).
Note: Screening fees are non-refundable after your application is submitted.
The screening turnaround time (TAT) for new drug applications (NDA) and generic drug applications (GDA) is 50 working days from the date of receipt of the application dossier. The TAT excludes any time taken by you to respond to our request for clarification or additional information (applicant's stop-clock).
If there is a need to change the application type, you will be informed of the change during screening via an IR.
Evaluation stages
Your application will progress to the evaluation stage when the application has been accepted upon screening completion. You may check the status of your application at track@prism.
| Evaluation stages |
Description |
Stage 1: Acceptance for evaluation
|
The application has entered the evaluation queue. This marks the start of the evaluation timeline |
Stage 2: Active evaluation in progress
|
Applicants can expect to receive the first set of evaluation queries (if any) from us towards the end of this stage.* |
Stage 3: Evaluation at midway
|
Applicants are expected to submit the response to evaluation queries.
|
Stage 4: Completed evaluation
|
Evaluation is completed. Application is now undergoing the regulatory decision phase, after which a regulatory decision# will be issued.
Applicants can still expect further queries from HSA during this stage.
|
* 120 - 160 working days from acceptance date, depending on application type and evaluation route. For applications without any evaluation queries, recommended changes to product labels will be communicated to the applicant during the regulatory decision phase. Refer to Appendix 5_Target Processing Timeline126 KB for more information.
#The issuance of a regulatory decision would mark the end of the evaluation timeline for a product application.
Application timeline calculator
Use this tool
to estimate the key milestone timelines for NDA and GDA full/abridged applications milestones
GO TO TOOL
Progressive Payment scheme
The progressive payment scheme is an opt-in scheme at the time of application submission. This is eligible for applicants who make payment via GIRO, and is only applicable to NDA submitted via full or abridged routes, and for all routes under GDA.
The table below shows the percentage payments applicable for each stage of the evaluation under the progressive payment scheme.
| Evaluation Stages |
Progressive payment scheme percentage |
Stage 1: Acceptance for evaluation
|
30% |
|
Stage 2: Active evaluation in progress |
40% |
Stage 3: Evaluation at midway
|
20% |
Stage 4: Completed evaluation
|
10% |
Once the application is submitted, the selected payment scheme (full or progressive) cannot be amended. If you wish to change your selected payment scheme, you will have to withdraw and re-submit the application. All upfront payments made, such as the screening fee, are non-refundable.
If an application under the progressive payment scheme is withdrawn during the evaluation stage, any fees that were charged, but not debited from the GIRO account, would remain payable. All paid fees are non-refundable.
Regulatory decision
You will be notified of one of the following outcomes after evaluation:
Approval
An approval decision means the application satisfies the registration requirements for quality, safety and efficacy.
Your product will then be added to the Register of Therapeutic Products. As the product registrant, you are responsible for ensuring the product's quality, efficacy and safety throughout its life cycle, and must notify us of any changes to these.
Approvable
An approvable decision indicates the application can be approved, subject to adequate responses to minor deficiencies.
You will be informed of the conditions for approval and you will be required to fulfil these conditions within a stipulated timeframe prior to the grant of a final approval.
Your application will be considered withdrawn if you fail to reply within the stipulated timeframe. Once the application is withdrawn, it is considered closed and you will be required to make a new application if you still wish to seek regulatory approval for the product concerned.
Non-approvable
A non-approvable application has major deficiencies that need to be addressed.
These deficiencies will be made known to you and if you wish to address them, your response should be based on the original data set submitted to us and furnished within the stipulated timeframe. New data not previously reviewed by us during the evaluation of the application concerned will not be accepted.
Your application will be considered withdrawn if you fail to reply within the stipulated timeframe. Once the application is withdrawn, it is considered closed and you will be required to make a new application if you still wish to seek regulatory approval for the product concerned.
Rejection
A rejection decision means your response failed to address the major deficiencies specified in the non-approvable decision.
A rejection decision is final.