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Evaluation Plan Estimators

15 August 2018

Before you lodge your pre-submission planning form (PPF) you can use the below evaluation plan estimators to approximate the dates of the milestones in the prescription medicine registration process. The estimators derive dates representing an example timeline using the TGA's business rules.

For PPFs that have been lodged and deemed to pass the preliminary assessment the TGA provides sponsors with an Evaluation Plan specific to the submission.

Note to sponsors who intend to lodge a submission to the November 2019 PBAC meeting under TGA/PBAC parallel processing arrangements:

For greater likelihood of receipt of the Delegate's request for ACM advice at least one week prior to the November 2019 PBAC meeting date, please consider the following options for lodgement of submissions to the TGA:

  • If submitting via the standard pathway, then submit your pre-submission planning form prior to 1 October 2018 and select the 30-calendar day response s31 period.
  • If submitting via the PPF-only pathway, then submit your pre-submission planning form prior to 15 November 2018 and select the 30-calendar day response s31 period.
  • If you intend to submit your pre-submission planning form before 1 September 2018, you can elect either a 30- or 60-calendar day S31 period.

For further clarification, please contact .

  • 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.

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PPF Estimators

This evaluation plan estimator is designed for sponsors who intend to lodge applications for prescription medicines under the PPF-Only Pre-submission Phase Option. This includes:

Approximate dates for COR report-based process milestones are available by contacting streamlined submission team, streamlinedsubmission@health.gov.au

(format MM-DD-YYYY)


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Milestone Description Date
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 ACM advice  
Pre-ACM response  
Proposed ACM meeting  
6 ACM outcomes  
7 Initial decision by Delegate – Decision Letter  
8 Completion of administrative and registration activities  

This estimator is designed for sponsors who intend to lodge Category 1 ‘standard’ applications for prescription medicines.

(format MM-DD-YYYY)


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Milestone Description Date
1 Outcome of PPF assessment - Planning Letter  
Submission due to be provided to the TGA  
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 ACM advice  
Pre-ACM response  
Proposed ACM meeting  
6 ACM outcomes  
7 Initial decision by Delegate – Decision Letter  
8 Completion of administrative and registration activities  

The next working day is applicable for dates that fall on weekends or public holidays.

Disclaimer

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.