Pre-submission Pilot Evaluation Plan Estimator
The evaluation plan estimator (the estimator) is designed for sponsors who need to lodge category 1, Type A and D applications (New Chemical or Biological Entities, Biosimilars or New Generic Medicines) for prescription medicines as part of the pre-submission pilot. It uses the information you supply to work out the approximate dates of the milestones in the Category 1 prescription medicine registration process.
The estimator can help you to identify the time-frames involved in lodging an application before you lodge your pre-submission planning form (PPF).
The dates derived through the estimator reflect the TGA’s business rules for the prescription medicines registration process; however they represent an example timeline only.
For actual PPFs lodged as part of the pre-submission pilot and assessed as effective, an Evaluation Plan specific to the submission will be provided to the sponsor by the TGA at Milestone 2.
- How to use the estimator
- All fields are required for the estimator to function
- Using the date picker enter the approximate date you intend to lodge your PPF
- When you enter a date the estimator will show your batch information
- Select the Section 31 response period you intend to nominate in your PPF
- Specify the application type (more information about application types can be found by hovering the mouse or tapping on the ? icon)
Once you have entered the required information into the estimator it will automatically update. Changing any of the fields will also cause the estimator to automatically update.
|Submission due to be provided to the TGA by|
|2||Outcome of submission assessment - Notification Letter|
|3||Outcome of 1st round evaluation - Consolidated s.31 request|
|4||End of day s.31 response period|
|5||Completion of evaluation phase|
|Deadline for notification to the TGA of errors/omissions in evaluation reports|
|Delegate’s request for ACPM advice|
|Proposed ACPM meeting|
|7||Initial decision by Delegate – Decision Letter|
|8||Completion of administrative and registration activities|
This estimator is provided by the TGA (a part of the Department of Health) solely for the purpose of providing general information on the TGA regulatory scheme. The dates derived through the estimator are consistent with the TGA’s business rules for the prescription medicines registration process, however they represent an example timeline only.
People requiring specific information or advice on the application of the therapeutic goods legislation in particular cases should make their own enquiries.
Whilst due care has been taken in its preparation, the Department of Health cannot guarantee, and assumes no legal liability or responsibility for the accuracy, currency or completeness of the information presented by the estimator.
The estimator reflects the business rules for the current category 1 prescription medicine registration process as of June 2015.