Registration overview of therapeutic products

  1. Application Screening and Evaluation stages

Application Screening and Evaluation stages

Understand what happens during application screening and evaluation, and how long each stage takes before we come to a regulatory decision.

Application screening

Application screening involves us checking to ensure 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 be done if:

  • The entire dossier sections are not submitted.
  • The submitted application dossier is not compiled according to the required Common Technical Document (CTD) format.
  • The Drug Master File (DMF) is not submitted (where applicable).
  • Assessment reports are not submitted (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. TAT may be extended with the time taken by you to respond to our request for clarification or additional information (applicant's stop-clock).

If your application is identified to be more appropriately submitted under a different application type during screening, you will be informed of the change via an input request.

Evaluation stages

The evaluation stage begins after the application is accepted upon screening. You may view the evaluation stage of your application at track@prism.

Evaluation stages Description
Stage 1: Acceptance for evaluation
Application is accepted for evaluation. This marks the start of the evaluation timeline.
Stage 2: Active evaluation in progress
When active evaluation is in progress for the application.
Stage 3: Evaluation at midway
Application is approximately midway through the evaluation. Applicants can expect to receive the first set of queries from us during this stage.
Stage 4: Completed evaluation
Evaluation is completed. Application is now undergoing the regulatory decision phase, after which a regulatory decision will be issued.

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
  • Approvable
  • Non-approvable
  • Rejection

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, which you will be informed if your application is considered to be non-approvable. A non-approvable decision means that the application has major deficiencies. and has major deficiencies that need to be address.

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.

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