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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
When an applicant lodges a Pre-submission planning form (PPF), the first phase of the prescription medicines registration process begins. Information about the process is provided in Prescription medicine registration process available on the TGA website.
The PPF provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application, including where relevant, the contracting of external evaluators.
A submission is one or more applications from the same applicant, with the same active ingredient, lodged at the same time. The dossier contains all the information required by the TGA to evaluate an application(s).
Applications for new registrations are lodged under section 23 of the Therapeutic Goods Act 1989 (the Act), while variations to existing registrations are lodged under section 9D of the Act.
A complete PPF identifies the proposed application type, and contains general information and details of 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.
For the TGA to considered a PPF to be an effective application under section 23(2)(d) or section 9D of the Act it must include all the information specified in the PPF. Once accepted the applicant will receive a Planning letter that identifies target milestone dates for the phases of the evaluation process.
In lodging a PPF, the applicant undertakes to lodge the entire dossier by the proposed lodgement date. Applicants should not therefore lodge a PPF until they are confident all necessary information required for an effective application will be ready for delivery by the proposed lodgement date.
This document assists applicants to complete the PPF dated April 2014. Applicants should not lodge a PPF without consulting this document.
Content of this document
This document contains the following information:
- instructions for completing each part of the PPF
- details of the content of any attachments that must be uploaded when the PPF is lodged
- where applicable, an explanation of the specific purpose for which the information is required, for example, allowing the TGA to manage concurrent processes where they occur, or ensuring various pre-conditions have been fulfilled
- any other actions applicants need to take
- general information of relevance to the PPF and the dossier.
The Pre-submission planning form
The PPF is divided into three parts:
- Part 1 - Applicant and product details
- 1.1 - Applicant details
- 1.2 - Product details
- 1.3 - Indications
- 1.4 - Planning
- Part 2 - Details of application
- 2.1 - General information
- 2.2 - CTD Modules 1–5
- 2.3 - Justifications and further information
- 2.4 - Summary of attachments
- Part 3 - Declaration
Completing the Pre-submission planning form
The PPF must be downloaded from the prescription medicines section of the TGA website and completed electronically. The TGA will not accept PPFs completed by hand.
To select or de-select a check box, either:
- use the mouse to select the check box
- use the keyboard to highlight the check box and press the space key.
Free text fields will expand to accommodate text. If more space is required, the information must be supplied in an attachment uploaded with the PPF.
The eBS help text provides assistance on completing the required information and naming the attachments to be uploaded. Help text is accessible from the pre-submission screen in eBS by clicking the 'help ' button in the top right hand corner of the screen.
Organisation of this document
The numbering of sections in this document follows the numbering in the PPF. Part 1, Part 2 (Sections 2.1 and 2.3) and Part 3 are numbered sequentially.
The numbering hierarchy used in Part 2, Section 2.2 - CTD Modules 1–5 corresponds directly to the numbering and hierarchy of the relevant CTD Modules and documents. The numbering in this part of the PPF is not sequential as references to CTD documents not relevant to the pre-submission phase (i.e. not required for an understanding of the scope and scale of the application) have been omitted.
For information on the common technical document (CTD) format and Modules, see the introduction of CTD Module 1: Administrative information and prescribing information for Australia.
Applicants must upload a number of attachments (documents providing additional information) when lodging the PPF through eBS. The prefix ** against the name of a document in the PPF identifies where attachments are required.
Naming of attachments
In some instances, the exact name of the attachment is specified in the PPF or in this document. Where the exact name is not specified, the name of the attachment must include, at a minimum, the following:
- PPF section number or CTD module number
- PPF section title or CTD module title
- where there are multiple attachments required within one section, a brief description of content.
For example, the attachment containing the copy of the orphan drug designation should be named '1.5.2 - Orphan drug designation'. Applicants should exercise judgement to ensure the TGA can clearly identify the appropriate attachments.
The following documents provide further information about the regulatory requirements for Category 1 and 2 applications for prescription medicines (other than applications solely for an additional trade name):
- Prescription medicine registration process. This document provides an overview of the TGA's regulatory processes for category 1 and category 2 applications.
- CTD Module 1: Administrative information and prescribing information for Australia
- Mandatory requirements for an effective application
- Questions and answers about the prescription medicines registration process. These pages are updated on a regular basis in response to queries from applicants about the process. Subscribe to the TGA-update email list to receive notifications when the Question and Answers page is updated
- General dossier requirements for prescription medicines.
What will the TGA do with this information?
The TGA will use the information in the PPF to:
- ensure correspondence to the applicant is directed to the correct person(s) at the correct contact details
- confirm that the application has been lodged under the correct regulatory framework and is the correct application type
- make a judgement about the scope and scale of the application and identify the expertise, work areas and resources required for the evaluation of the application
- confirm that the proposed application(s) can be treated as a single submission as specified in subclauses 1(2) and 1(3) of Part 1, Schedule 9 to the Therapeutic Goods Regulations 1990 (i.e. multiple submissions are not required)
- manage any potential scheduling issues. For example, if the TGA must make a scheduling decision, the timeframe for the evaluation process may need to be altered to allow for a scheduling committee meeting
- determine whether the completion of the evaluation of any related application is necessary before the proposed application can proceed
- ensure that, if and where appropriate, the results of previously evaluated work are considered and any deficiencies or issues identified with a previous PPF or dossier have been addressed
- determine the target milestone dates for the evaluation process, including the appropriate ACPM meeting should the delegate choose to refer the application to this committee
- confirm that any relevant pre-conditions to lodging a PPF have been met:
- notifications of new proprietary ingredients and applications for new AANs have been lodged
- the justification for a new fixed combination is acceptable
- all elements of a literature search strategy have been approved if a literature based submission
- the medicine, the dose form, and the indication(s) proposed are covered by an orphan drug designation
- required applications for GMP clearances or licences have been lodged and are active
- consider the impact of the proposed justifications in relation to:
- the information to be evaluated and its impact on the evaluation plan
- potential technical issues with the proposed justification(s)
- whether the applicant has provided an overview of all justifications that are likely to be required in the dossier.
- consider the information and note in the Planning letter whether the applicant should take any special action prior to lodging the dossier.