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Information for applicants completing a pre-submission planning form

Applicable to pre-submission planning forms lodged under the prescription medicines registration process from 1 May 2014

1 May 2014

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CTD Module 2-5 and further information

Module 2 (Summaries Module)

Will Module 2 form part of the dossier?

How to complete this information

Confirm that Module 2 will be provided in the dossier.

Using the list provided, check 'Y' next to each section of Module 2 (or its equivalent) that will be attached to the PPF.

Where an applicant believes the requirement for a document is 'not applicable' for a particular application, a justification must be included in section 2.3 Justifications and further information.

What else do I need to do?

For information on the content of Module 2, see the Module 2 information on the CTD guidelines.

Module 2 is a module that summarises the data to be provided in Modules 3, 4 and/or 5. The TGA requests, wherever possible, applicants provide a complete draft of CTD Module 2, but recognises not all applicants will have a complete Module 2 prepared at the time of PPF lodgement. As such, the TGA allows applicants to fulfil this requirement for Module 2 data by providing either:

  • a complete draft of CTD Module 2 (containing all the sections of Module 2 that are relevant to the application type)
  • draft summaries of CTD 2.3.S, 2.3.P, 2.4, 2.5, 2.6.2 or 2.6.3, 2.6.4 or 2.6.5, 2.6.6 or 2.6.7, 2.7.1, 2.7.2, 2.7.3, 2.7.4, 2.7.6 as appropriate for the application type
  • documents containing the equivalent information to the draft summaries listed in the point above.

A nonclinical overview (Module 2.4), or equivalent, will be required when:

  • Module 4 information will be submitted as part of the application
  • the product includes a novel excipient or involves the novel use of an excipient
  • levels of impurities and degradants exceed guideline recommendations
  • there is a deviation from TGA or adopted nonclinical guidelines
  • there are changes to the nonclinical aspects of the Product Information
  • where the application refers to Module 4 data that have been previously submitted and, for example, the applicant wishes to 'reinterpret' these studies (perhaps in the light of new data).

A clinical overview (Module 2.5), or equivalent, will be required when:

  • Module 5 information will be submitted as part of the application
  • the application involves a new generic medicine
  • there is a deviation from TGA or adopted clinical guidelines
  • there are changes to the clinical aspects of the Product Information
  • where the application refers to Module 5 data that have been previously submitted and, for example, the applicant wishes to 'reinterpret' these studies (perhaps in the light of new data).

An 'equivalent' document is one that:

  • may be in either draft or final version
  • contains all the information specified in the relevant section of Module 2 but does not need to be in the format or structure specified by the relevant section of Module 2.

For example, an applicant's internal document used for the initial consideration of the viability of a new chemical entity product that provides all of the information required by sections 2.3.S, 2.3.P, 2.4, 2.6.2, 2.6.4, 2.6.6, 2.5, 2.7.1, 2.7.2, 2.7.3 and 2.7.4 but is presented in a different structure would be acceptable.

Important note

The TGA requests that, wherever possible, applicants provide a complete draft of Module 2. Where this is not possible, equivalent information must be provided. This information allows the TGA to arrange appropriately qualified and resourced external evaluators for the application.

A 'complete draft' of Module 2 is considered to be a draft that contains all the sections of Module 2 that are relevant to the application type. For example, for an extension of indication application where the quality information about the products is not changing, the CTD summaries 2.3.S and 2.3.P would not be provided. For more information, refer to the dossier documents matrix of CTD Module 1.

Module 3 (Quality Module)

Will Module 3 form part of the dossier?

How to complete this information

Respond to the statement 'Module 3 will form part of dossier':

  • if yes, select the 'Y' box and complete the information requested under CTD Module 3.2.S and CTD Module 3.2.P.
  • if an applicant is not supplying a Module 3 with the dossier, but the application makes reference to a Module 3, DMF, or PMF provided to the TGA previously, the 'Y' box must be selected.
  • if no, select the 'N' box and go to CTD Module 4 - Nonclinical Module.

Module 3.2.S - Drug substance

To complete the manufacturer table in Module 3.2.S, record the details of all manufacturing sites involved with the production of the drug substance (active ingredient).

  • Where there are multiple active ingredients with separate manufacturing sites, the active ingredient must be identified in the manufacturing steps field, for example, 'active ingredient manufacture for perindopril arginine'.
  • It is not necessary to provide the details of excipient manufacturers, except where the excipient plays a role in the delivery of the active ingredient, for example, serum albumin being used as a carrier of the active ingredient.

Module 3.2.P - Drug product

To complete the manufacturer table in Module 3.2.P, record the details of all manufacturing sites involved with the production of the drug product.

Where the application covers multiple dosage forms or components with different manufacturing sites, this must be identified in the manufacturing steps field, for example, 'manufacture of dosage form for tablet'.

It is not necessary to provide the details of excipient manufacturers, except where the excipient plays a role in the delivery of the active ingredient.

To complete the remaining information under Module 3.2.P, follow the information provided on the PPF.

What else do I need to do?

If there is insufficient space in either table at 3.2.S or 3.2.P, insert the comment 'see attached document' into the first row. Create a separate document to record the required information and upload as an attachment with the PPF in eBS.

All manufacturers listed at Part 2, Section 2.2, CTD Module 1.7 - Good manufacturing practice, must be included in CTD Module 3.2.S and CTD Module 3.2.P. It is possible, however that some manufacturing sites included in Modules 3.2.S and/or 3.2.P are not included at Module 1.7 as their role is not considered to be sufficiently significant to warrant GMP clearance. Refer to Appendix B for information on the TGA's requirements for manufacturer information, GMP licences and clearances, and timeframes for processing applications for GMP licences and clearances.

Module 4 (Nonclinical Module)

Will Module 4 form part of the dossier?

How to complete this information

If the applicant either:

  • indicated in Section 1.4 (Submission planning) that Module 4 information is to be supplied
  • intends to refer in the application to Module 4 information provided to the TGA previously

select this box to indicate that Module 4 will form part of the dossier and answer the remaining questions in the section. Otherwise, go to CTD Module 5 - Clinical Module.

Are literature references (Module 4.3) to be included in the dossier?

How to complete this information

Confirm whether literature references are to be supplied as part of Module 4. If references are to be evaluated, they must be included in the 'Listing of nonclinical studies' as described in the Module 2 section.

Indicate the number of literature references included in the dossier in relation to Module 4.

Ensure the bibliographic details of all literature references are included in the comprehensive table of contents (see Module 1.1). The following information must be provided in Module 1.1, at a minimum:

  • author(s)
  • date
  • title of article/chapter
  • name of journal/book
  • page numbers.

Module 5 (Clinical Module)

Will Module 5 form part of the dossier?

How to complete this information

If the applicant either:

  • indicated in Section 1.4 (Submission planning) that Module 5 information is to be supplied
  • intends to refer in the application to Module 5 information provided to the TGA previously

select the box to indicate that Module 5 will form part of the dossier and answer the remaining questions in the section. Otherwise, go to Part 2.3 - Justifications and further information.

Tabular listing of clinical studies

How to complete this information

Attach CTD Module 5.2 which is a tabular listing of clinical studies to be evaluated.

Module 5.2 is to include only those studies that will form part of the dossier. It must not include a listing of all studies performed with the product/indication.

If this is a literature-based submission, the listing of clinical data must include all literature references to be evaluated by the TGA should be included in Module 5.2, including the following details:

  • author(s)
  • date
  • title of article/chapter
  • name of journal/book
  • page numbers.

Studies/literature references which are not primary studies to be evaluated by the TGA but which are provided as references must be included in 'Literature references' (Module 5.4).

For literature-based submissions, refer to the specific instructions on the PPF for the inclusion of references.

Are literature references (Module 5.4) to be included in the dossier?

How to complete this information

Confirm whether Module 5.4 will be supplied as part of the dossier. In this instance, literature references are not primary data to be evaluated by the TGA. If references are to be evaluated as primary data, they must be included in the 'Tabular listing of clinical studies' above.

Indicate the number of literature references included in the dossier.

Ensure the bibliographic details of all literature references are included in the comprehensive table of contents (see Module 1.1). The following information must be provided in Module 1.1, at a minimum:

  • author(s)
  • date
  • title of article/chapter
  • name of journal/book
  • page numbers.

2.3 Justifications and further information

Justification for not providing appropriate biopharmaceutic and/or bioavailability data

How to complete this information

Consider the biopharmaceutic and/or bioavailability data to be provided in the dossier and assess whether it meets the requirements identified in the TGA guideline Biopharmaceutical studies and any EU guidelines adopted by the TGA that relate to biopharmaceutic studies.

Where the data does not meet the requirements set out in these documents, the application must include an appropriate ('robust scientific') justification that addresses the information in the TGA guideline Biopharmaceutical studies and the EU guidelines. Where there are multiple guidelines/requirements in TGA guideline Biopharmaceutical studies and/or relevant EU guidelines that have not been met, applicants will need to provide a justification for not meeting each one.

Where a justification for not providing biopharmaceutic data (or not providing data for all products) is required, the justification must address, as a minimum, the points set out in the TGA guideline Biopharmaceutical studies.

Applicants must note meeting the EU guidelines alone is not sufficient.

Using the space provided in the PPF, provide an overview of the justification(s) that will be provided in the application in relation to biopharmaceutic and/or bioavailability studies. Although an overview, the applicant must address all criteria mentioned in relevant guidelines.

If there is insufficient space, record the relevant details in a separate document and upload the document as an attachment with the PPF. Annotate the field to refer TGA staff to the appropriate attachment.

What else do I need to do?

Confirm that the mandatory requirements relevant to your application set out in the Mandatory requirements for an effective application have been met.

Important note

To be considered effective, the application must meet the requirements set out in Mandatory requirements for an effective application and other relevant regulatory and supporting documents.

In considering the dossier, the TGA will assess whether the justification provided for not meeting a relevant guideline is a robust scientific justification. A robust scientific justification is one that:

  • clearly identifies the guideline or part of the guideline that the applicant is proposing not to meet
  • specifically addresses why the guideline is not being met
  • is based on contemporary scientific evidence
  • includes citations to the relevant reference documents, including TGA documents, where appropriate.

Justification for not meeting other guidelines

How to complete this information

Consider the remaining (i.e. non-biopharmaceutic) data to be provided in the dossier. Where the data does not meet applicable adopted EU guidelines or a TGA guideline, the application must include an appropriate (robust scientific) justification that takes account of the requirements of the relevant guideline. Where there are multiple guidelines/requirements that have not been met, applicants will need to provide a justification for not meeting each one.

Using the space provided in the PPF, provide an overview of the justification(s) to be provided in the application.

If there is insufficient space, record the relevant details in a separate document and upload it as an attachment when lodging the PPF. Annotate the field to refer TGA staff to the appropriate attachment.

Further information

How to complete this information

Consider the data to be included in the dossier. Use the space provided to tell the TGA any further information that:

  • is relevant to the TGA's consideration of the PPF that has not been recorded elsewhere in the form
  • may be relevant to the TGA's planning and scheduling of evaluation resources for the application.

If there is insufficient space, record the relevant details in a separate document and upload the document as an attachment when lodging the PPF. Annotate the field to refer TGA staff to the appropriate attachment.

Information not relevant to the TGA's determination of the scope and scale of the dossier must not be recorded in this space.

2.4 Summary of attachments

This list is for the benefit of the applicant to ensure all important attachments are included with the PPF.

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