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Prescription medicines registration process

3 August 2020

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Phase 1: Pre-submission

5.1.1 Objective

diagram showing the pre-submission process

The pre-submission phase applies to category 1 and category 2 applications, excluding requests for additional trade names.

The pre-submission phase begins with the lodgement of the Pre-submission planning form (PPF). The PPF provides the TGA with the necessary information on the scope and scale of an application to arrange appropriate resourcing for the processing and evaluation of the application. Once a PPF has been considered complete and acceptable, the TGA begins the process of securing appropriate evaluators for the dossier.

A complete PPF identifies the proposed application type, and contains general information about the quality, nonclinical, and clinical evidence to be included in the dossier. The information provided in the PPF allows the TGA to commit to timeframes for the evaluation of the application.

5.1.2 Milestone 1

If the PPF is considered complete and acceptable, a TGA Planning letter is sent to the applicant identifying the expected dossier lodgement date and target milestone dates for the application.

5.1.3 Key dates

The pre-submission phase commences with the lodgement of a PPF. PPFs are processed on the first day of each month.

The submission phase concludes when TGA sends the applicant a Planning letter. This letter is sent to applicants before or on the fifteenth of the month following the month in which the PPF was initially processed (or the following working day where the fifteenth of the month falls on a weekend or public holiday in the Australian Capital Territory).

5.1.4 Requirements at pre-submission

5.1.4.1 Pre-submission planning form

Applicants must complete and lodge a Pre-submission planning form. All sections of the PPF that are relevant to the proposed application must be completed. Information for applicants completing a pre-submission planning form is a step-by-step guide for applicants completing a PPF. If the applicant does not complete all relevant sections and provide the necessary documents as attachments, the TGA will consider the PPF not complete and not acceptable. Should the applicant wish to proceed with the registration of the medicine or the variation to the register entry, they will need to lodge a new PPF.

5.1.4.2 Module 2 data

A key element of the PPF is the provision of Module 2 (or equivalent) data which contains information on the scope, scale, and complexity of the proposed dossier. The TGA encourages the attachment of a complete CTD Module 2. The requirements for module 2 content at the pre-submission phase are explained in more detail in the Pre-submission planning form and Information for applicants completing a pre-submission planning form.

The TGA uses the information lodged by applicants in the PPF to plan the necessary resourcing to process and evaluate the application and to commit to milestone dates in the Planning letter. The information is particularly crucial when the TGA needs to secure external evaluators.

5.1.5 Lodging a pre-submission planning form

5.1.5.1 On-line form via eBS

Completion and lodgement of a PPF is a two-step process that uses the TGA's secure eBS portal (see Information for applicants completing a pre-submission planning form.)

Comment

The PPF is currently downloaded from the TGA website, completed, and lodged with the TGA through eBS. The TGA is working to develop an online smart form in eBS to replace this document. Smart form technology will allow the form to be pre-populated with automatically retrieved applicant information.

5.1.5.2 Certification by applicant

The applicant must declare on the PPF that they understand the TGA's requirements for an effective application and that the application will be processed by the TGA in accordance with the procedures described in Prescription medicine registration process (this document).

The TGA's requirements for an effective application are established though legislative instruments made under section 9D and section 23 of the Act. Under these instruments, the planning information provided at pre-submission, along with the application form, and dossier (containing data for evaluation) comprise the information required under section 9D and section 23 of the Act to allow determination of the application.

5.1.5.3 Application fee

Upon lodgement of a PPF, applicants become liable to pay the application fee2. The application fee allows the TGA to recover the costs associated with processing the PPF and arranging evaluation resources. If a PPF is considered 'not effective' or the dossier is not subsequently accepted for evaluation, the applicant will forfeit this application fee. An application cannot be considered effective if the application fee has not been paid.

The application fee amounts are available at the fees and payments section of the TGA website.

2An application fee is not payable for applications made under section 23 of the Act and involving a medicine which has been designated an orphan drug.

5.1.6 Change of details after pre-submission

The TGA Planning letter (issued when a PPF is considered complete and acceptable) contains:

  • the lodgement date for the dossier
  • the expected dates for the milestones of the regulatory process
  • any issues the TGA has identified when considering the PPF which need to be addressed in the dossier. For example, the TGA may indicate whether a proposed justification is not sound, giving the applicant time to make amendments before dossier lodgement.

When lodging the PPF, the applicant declares that they will provide a complete application dossier, the contents of which align with the information provided in the PPF, by the date that they have specified in the PPF. If it appears that the scope or scale of the dossier will be different to that described in the PPF, there is a riskthat the applicationwill be considered 'not effective'. Examples of changes that are likely to result in an application being considered 'not effective' include:

  • a significant change of proposed indication or addition of an indication
  • an increase in the number of studies that form key sources of evidence (including, but not limited to, pivotal phase III studies, biopharmaceutic studies and carcinogenicity studies)
  • a new strength
  • an additional trade name.

The TGA recognises that some information may change before a dossier is lodged, for example, new safety information becomes available or further information needs to be included to address issues that the TGA raises in the Planning letter. Where the information that needs to be included impacts on the scope and scale of the application, applicants are advised to contact the TGA before lodging the application dossier.

Any differences between the dossier and the information provided in the PPF must be acknowledged in the covering letter for the dossier then described in detail and justified in Module 1.8.3: Declaration of compliance with the pre-submission planning form and planning letter. Refer to CTD Module 1 for more information on preparing these documents.

Applicants should note that where the application differs in scope or scale from that described in the PPF but the TGA agrees to proceed with evaluation, the TGA will need to reassess resources and may need to adjust milestone dates accordingly.

5.1.7 Application dates

The TGA Planning letter outlines the key dates for each phase of the regulatory process, including the expected date of dossier lodgement. The dossier may be lodged any time between the receipt of the Planning letter and close of business on the expected date of lodgement identified in the Planning letter. Applicants are encouraged to lodge their dossier as early as possible. However, early lodgement of the dossier will not result in an earlier achievement of milestone 2.

The Planning letter also identifies the date on which it is proposed to send the section 31 request for information or documents to the applicant and the date by which the applicant must respond to the request. This allows applicants to prepare to address any issues raised.

5.1.8 What happens if an applicant misses a key date?

To be included in a given monthly batch, the PPF must be received on or before the day preceding the first day of each month. A PPFlodged on the first day of a month will not be processed until the following month.

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