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Registration overview of Class 2 CTGTP

  1. Application evaluation and regulatory decision

Application evaluation and regulatory decision

Understand the evaluation process and the different types of regulatory decisions.

Evaluation stage

The evaluation stage begins when the application is accepted after screening and ends when a regulatory decision is issued.

If clarification or additional information is required, an input request will be issued to you and the application stop-clock will be initiated. The stop-clock ends upon the receipt of a complete and satisfactory response from the applicant.

HSA may engage external evaluators, experts and advisory committees in the evaluation process, when necessary. All external evaluators and experts are bound by agreement to protect the information made available to them. The identity of the external evaluators is kept confidential.

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 Cell, Tissue and Gene Therapy 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 granting 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Your application will be considered withdrawn if you fail to reply within the stipulated timeframe. Once the application is withdrawn, it is considered closed and you will be required to make a new application if you still wish to seek regulatory approval for the product concerned.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.

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