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Prescription medicines registration process

3 August 2020

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Phase 3: First round assessment

5.3.1 Objective

a diagram showing the steps of the consolidated section 31 request response phase

All data provided in the dossier are considered by the evaluators during the first round assessment phase. Where there are issues or questions about any component of the application, a consolidated section 31 request for information containing requests from all evaluation areas within the TGA is compiled and sent to the applicant by the date specified in the Planning letter.

Within this phase, TGA evaluators may directly contact the applicant to seek clarification or ask questions informally if they determine that waiting for the formal consolidated section 31 request on a minor clarification is unnecessary. This type of informal question will not change the timeline for the consolidated section 31 request.

5.3.2 Milestone 3

Applicants will be sent a Milestone 3 letter including:

  • a consolidated section 31 request for information or documents, if required
  • copies of the first round assessment reports prepared by the quality, nonclinical, clinical and RMP evaluators.

5.3.3 Key dates

The first round assessment phase commences the day after the Notification letter has been sent.

The first round assessment phase concludes 4 (generic applications) or 5 (all other applications) months later when TGA sends the applicant a Milestone 3 letter. This letter is sent to applicants before the end of the applicable month (or the following working day where the last day of the month falls on a weekend or public holiday in the Australian Capital Territory).

5.3.4 Assessment of data

5.3.4.1 Period for evaluation

The default timeframes for the first round evaluation of the data are:

  • 3 months for the evaluation of new generic medicine applications
  • 4 months for the evaluation of other applications.

Following evaluation of the data, a consolidated section 31 request for information or documents will be compiled, checked, and authorised within 1 month of the completion of the first round assessment and sent to the applicant. This allows the TGA to ensure that issues and concerns from all evaluation areas are clearly identified and consolidated into the request.

5.3.4.2 External evaluators

The TGA may contract external evaluators to review aspects of the dossier. The TGA will coordinate the evaluation with the external evaluator as part of the first round assessment phase. Communication with the applicant in relation to an evaluation will always be through the TGA.

5.3.5 First round assessment reports

The first round assessment reports are sent with the Milestone 3 letter and will help to provide a context for any request for information or documents.

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