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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 1

Module 1.1 - Comprehensive table of contents

How to complete this information

Prepare a draft comprehensive table of contents for the dossier. This must include entries for Modules 3, 4, and 5 (as applicable to the application type) and include literature references. Entries for Modules 1 and 2 may also be provided if available.

The table of contents must include entries down to the individual document level.

The CTD format specifies various locations for literature references, namely Modules 2.5.7, 2.7.5, 3.3, 4.3, and 5.4. Where any of these modules appear in the table of contents, the full bibliographic details of all the references in these modules of the dossier must be included in the table of contents. At a minimum, the following information for each literature reference must be listed in the table of contents:

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

Check the Y box to indicate this draft document will be uploaded as an attachment when lodging the PPF.

Further information

This document must be either a text document or a text-searchable PDF. A scanned document is not acceptable.

Module 1.3.1 - Draft product information (PI)

Will the application result in a new or revised PI?

How to complete this information

A category 1 or category 2 application may result in the creation of either a new PI document or the revision of an existing PI document.

For applications for new registrations where a new PI document is to be provided, this may be provided in the form of an overseas document or a draft Australian PI. In either case, the proposed indications, dose form(s), dose regimen, and formulation for Australian purposes must be included as a minimum.

Where an existing PI is being modified, the changes must be clearly highlighted on the draft PI (see CTD Module 1 for details).

If changes to an existing PI are currently under evaluation as a result of a separate application, applicants must identify these separately, indicating they are currently under review. In this case, the attachment must include the relevant submission ID (the number recorded at Part 1, Section 1.4, Related applications).

On completion, tick the appropriate check box(es) to indicate which document is being provided as an attachment.

Further information

Applications for the registration of a 'restricted medicine' must include product information documents. A 'restricted medicine' is defined by the Restricted Medicine Specification 2011.

Applications for some other medicines also require the lodgement of product information documents. The delegate of the Secretary may decide under subsection 25(1)(da)(ii) of the Act that an application must include product information. If this is the case, the applicant will be advised in the Planning letter.

All product information lodged in the dossier must be provided in the form approved by the Secretary of the Department of Health and Ageing. Information about this form is provided in the TGA guideline on Product Information available from the TGA website.

Module 1.5.1 - Literature-based submissions

Is this a literature-based (bibliographic) submission (LBS) for Module 4 or Module 5?

A literature-based submission (LBS) is an application that relies solely or partly, on bibliographic data to support the safety and efficacy claims. For further information about LBSs see the guideline Literature-based submissions, available on the TGA website.

Some applications involve a dossier where Module 4 and/or 5 consist(s) of a combination of reports of limited nonclinical and/or clinical studies carried out and of bibliographical references. The TGA will treat such an application as a LBS.

If the literature search strategy and the criteria for inclusion/exclusion of papers have not been approved prior to PPF lodgement, the PPF will be considered not complete and not acceptable for evaluation.

How to complete this information

If you are preparing a LBS, then prior to lodging the PPF the TGA will need to have reviewed and approved your:

  • literature search strategy, including the databases to be searched
  • the criteria for determining which search results are to be included/excluded in the dossier.

On receipt of written advice from the TGA advising of acceptability of the above literature search elements, prepare the PPF, selecting the check boxes to identify which modules include literature references for evaluation. Attach copies of the TGA's advice indicating that the above elements are satisfactory.

Important note

Applicants who are lodging a literature-based submission must pay particular attention to the bibliographic requirements at Part 2, Section 2.2, CTD Module 4 - Nonclinical module, and CTD Module 5 - Clinical module.

Where the application is a literature–based submission, applicants must list all references in the Comprehensive Table of Contents. The references must also be included in the relevant sections of the 'tabular listing of all clinical studies' (Module 5.2) and 'nonclinical tabulated studies' (Module 2.6). See the information at CTD Module 4 - Nonclinical Module, and CTD Module 5 - Clinical Module, for further instruction on completing these sections.

Module 1.5.2 - Orphan drug designation

If this application is for a new register entry, has this medicinal product been designated an orphan drug for the proposed indication and dose form?

How to complete this information

Select the appropriate check box to indicate whether the medicine has been granted orphan drug designation, if relevant to the proposed application (that is, application under section 23 of the Act).

If designation has been granted and is applicable to the application being made, attach a copy of the TGA letter approving orphan drug designation.

Further information

Orphan drug designation is specific to the medicine, the dose form, and the indication(s). The application and evaluation fees will only be waived if the medicine, the dose form, and the proposed indication(s) in the application are identical to, or a subset of, those approved in the orphan drug designation.

If applicants fail to obtain orphan drug designation before lodging a PPF, they will be liable for application and evaluation fees. For further information, see section 4.3.1: Orphan drug applications of Prescription medicine registration process.

Module 1.5.3 - Genetically modified organisms

Does this product contain or consist of genetically modified organisms?

Is the product derived from a genetically modified organism that is manufactured in Australia or overseas?

How to complete this information

Select the appropriate check box to indicate whether the product contains or consists of genetically modified organisms (GMO).

  • If no, proceed to CTD Module 1.6 - DMF, PMF, and CEP.
  • If yes:
    • Upload as an attachment a copy of any Office of the Gene Technology Regulator (OGTR) licence, acknowledgement of receipt, or other record of consent from OGTR. For further information, see Module 1.5.3: Genetically modified organisms - Consent from the Office of the Gene Technology Regulator of CTD Module 1.
    • Select the appropriate check boxes to indicate whether the product is derived from genetically modified organisms and manufactured in Australia or overseas.
      • If the product is derived from genetically modified organisms and is manufactured in Australia, upload as an attachment, a copy of any OGTR licence, acknowledgement of receipt, or other record of consent from OGTR with the PPF; or alternatively, a declaration of exemption (see Module 1.5.3 of CTD Module 1 for more information).
      • If the product is manufactured overseas, proceed to CTD Module 1.6 - DMF, PMF, and CEP.

Important note

A product derived from a GMO is one that contains highly purified protein(s) derived from the GMO with a negligible amount of genetic material present. Contact the TGA for further advice if required.

To determine whether your product is subject to regulation under the Gene Technology legislation contact OGTR for advice.

What else do I need to do?

If applicants are intending to apply to the TGA to use a GMO as a medicine, they are advised to consult the Office of the Gene Technology Regulator (OGTR) prior to lodging a PPF to determine their obligations under the Gene Technology Act 2000. Further information can be obtained from www.ogtr.gov.au.

Where a medicine contains or consists of GMOs, applicants must include in the dossier, a copy of any written consent from the OGTR for the use of the genetically modified organisms at Module 1.5.3: Genetically modified organisms – Consent from the Office of the Gene Technology Regulator.

Module 1.6 - DMF, PMF and CEP

How to complete this information

This section needs to be completed for new registrations and where changes are proposed to the quality (Module 3) information for existing registrations.

If the application makes reference to a drug master file (DMF), check the 'Y' box next to 'drug master file' (DMF) and enter the TGA's file number (quoted on the TGA letter to the DMF holder confirming receipt of the DMF) in the space provided.

If the application makes reference to a Certificate of Suitability of Monographs of the European Pharmacopoeia (CEP), check the 'Y' box and enter the reference number in the space provided.

If the application makes reference to a plasma master file (PMF):

  • check the 'Y' box next to 'plasma master file' (PMF)
  • indicate whether the PMF has been previously approved by the TGA
  • if yes, record the name of the PMF in the space provided enter the TGA's reference number (quoted on the TGA letter to the PMF holder confirming receipt of the PMF) in the space provided.

An application may make reference to multiple DMFs, PMFs and/or CEPs. Record the full details for all. If there is insufficient space, record the relevant details in a separate document and upload as an attachment when lodging the PPF. Annotate the space(s) provided in this section to refer the TGA to the appropriate document.

Important note

All DMFs and PMFs relevant to an application must be received by the TGA before the dossier is lodged. The applicant is responsible for confirming with the DMF provider(s) that all necessary documents have been lodged with the TGA. If there are delays in providing the TGA with DMF related information requested under section 31 of the Act, then the TGA will proceed with the evaluation process at the end of the section 31 response time nominated by the applicant at the time of application.

Further information

For further information on DMFs, PMFs, and CEPs, see section 4.1.7 and the TGA guideline on drug master files.

Module 1.7 - Good manufacturing practice

Will Module 3 form part of the dossier?

How to complete this information

Check the appropriate box for the inclusion of Module 3 in the dossier.

  • If the application will include a Module 3, select the 'Y' box and complete the information required in the two tables for all the manufacturers in the supply chain for the product(s).
  • If the application will not include a Module 3, but the application makes reference to a Module 3, DMF, or PMF provided to the TGA previously, select the 'Y' box.
  • If the application will not include a Module 3 and the application does not make reference to a Module 3, DMF, or PMF provided to the TGA previously select the 'N' box.

To complete the tables, review the manufacturing sites in the supply chain for the products(s) and follow the instructions below.

For all overseas manufacturing sites:

  • Enter the manufacturer's details into the overseas manufacturers table, including the TGA's GMP clearance or certification tracking number (in the format MI-YYYY-CL-NNNNN-N). Check the box to indicate GMP is 'currently cleared' or 'clearance required'.

If any of the following apply:

  • no clearance currently available
  • the clearance does not cover the necessary manufacturing steps
    • the applicant must lodge an application for the clearance/renewal via eBS prior to completing the PPF. Once lodged, enter the manufacturer's details into the overseas manufacturers table, including the TGA's GMP clearance tracking number, in the PPF. Check the box to indicate clearance is required.

Applicants must ensure that at the time of lodgement of the PPF all pending applications for clearance are active. An active application is one in which the appropriate application form and all relevant information (see 17th edition of Guidance on the GMP clearance of overseas medicine manufacturers) have been submitted to TGA and the applicable fees paid.

For all Australian manufacturing sites:

  • If there is a current TGA manufacturing licence for the manufacturing site, enter the manufacturer's details, including the TGA manufacturing licence number. Check the box to indicate it is currently approved.

If there is either:

  • no licence currently available
  • the licence does not cover the necessary manufacturing steps
    • ensure that the manufacturer has lodged an application for the licence. Once lodged, enter the manufacturer's details, including the TGA's GMP licence or tracking number. Check the box to indicate approval is required.

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 table(s) in this section to refer the TGA to the appropriate attachment.

What else do I need to do?

Applicants should take steps prior to lodging the PPF to verify the adequacy of the manufacturer's GMP compliance. Delays in securing GMP clearance for a site due to poor compliance can result in an application being rejected at the decision phase.

Applicants are responsible for monitoring existing GMP clearances that may be due to expire prior to the decision phase. Applicants must make an application for a new GMP clearance to ensure all sites hold a licence or GMP clearance prior to the decision phase.

Further information

Clearances and applications for clearances must be for the correct sites and the appropriate manufacturing steps. For example, if a site is to be used for the manufacture of capsule dosage forms, the site must have clearance for manufacturing dosage forms for capsules, solid dosage forms, or all dosage forms.

Refer to Appendix B for important information regarding the TGA's requirements for manufacturer information, GMP licences and clearances, and timeframes for processing applications for GMP licences and clearances.

Module 1.8 - Meetings

Has written pre-submission advice been sought from TGA?

Has a pre-submission meeting been held with the TGA regarding this application?

How to complete this information

Where the applicant has held one or more scientific advice meetings and/or pre-submission meetings with the TGA, or TGA's advice about an application has been sought, the applicant should attach relevant documents (for example, copies of correspondence, meeting minutes, action items) and discuss how/when any issues identified at these meetings will be addressed.

Module 1.10.1 - Overseas regulatory status

Has there been, or is there an intention to make similar applications for market approval in any of the following regions or countries?

How to complete this information

If an application, similar to the one that is the subject of the PPF, has been made in the EU, USA, Canada, New Zealand, Singapore or Switzerland, select the 'Y' box. Complete the remaining information in the section. Otherwise, select the 'N' box.

Where applications have been submitted to agencies in the European Union, include the type of application (centralised, mutual recognition, decentralised, or national).

Refusal of market approval or withdrawal refers to an application not being accepted for evaluation, rejected after evaluation, withdrawn by applicant or otherwise found to be non-compliant, It also includes suspension or withdrawal of marketing approval by either an overseas regulatory authority or the applicant. Details must be included in the PPF. If there is insufficient space, record the relevant details in a separate document and upload the document as an attachment with the PPF.

What else do I need to do?

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

Module 1.13 - Pharmacovigilance

Will a risk management plan be included in the dossier?

How to complete this information

Select the appropriate check box to indicate whether a risk management plan (RMP) will be provided with the application.

If an RMP will not be provided with the application, a justification for this must be included in the space provided:

  • if an RMP is not required due to application type, this must be stated
  • if the Office of Product Review (OPR) has agreed that an RMP is not required, this must be stated and details of the discussions and rationale provided. Upload as an attachment, a copy of the advice from the OPR stating that a risk management plan is not required.
  • if an RMP is not being provided but has been identified in CTD Module 1 as required for the given application type, a justification must be provided for its exclusion.

For further information see CTD Module 1: Module 1.13: Pharmacovigilance, RMP for prescription medicines, guidelines on pharmacovigilance for medicinal products for human use adopted from the EU and the Questions and answers about the prescription medicines registration process.

What else do I need to do?

Applicants may need to contact the OPR for confirmation on the requirement for an RMP. Applicants should consult the reference material listed above prior to contacting OPR.

The TGA will advise the applicant in the Planning letter whether any further action is required prior to application lodgement in relation to an RMP.

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