Mandatory requirements

On this page: Organisation and format of the application dossier | Content of the application dossier | Justification for not complying with technical data requirements and not adhering to guidelines | Compliance with administrative requirements

Organisation and format of the application dossier

The applicant must provide an application dossier that has been completed and structured in accordance with the relevant instructions specified in:

• CTD Module 1: OTC medicines. Completed to the extent that it is applicable for all OTC application levels.
• Module 2: Overviews, written summaries and tabulated summaries of the data contained in the Modules 3, 4 and 5. Completed to the extent that it is applicable for particular N3, N4, N5, C3 and C4 applications, as detailed in Appendix A: Specific mandatory requirements (Module 2).
• Module 3: ICH M4Q Common technical document for the registration of pharmaceuticals for human use - Quality (CPMP/ICH/2887/99 Rev 1 Quality). Completed to the extent that it is applicable for particular N1, N2, N3, N4, N5, and C2 applications, as detailed in Appendix A: Specific mandatory requirements (Module 3).
• Module 4: ICH M4S Common technical document for the registration of pharmaceuticals for human use - Safety (CPMP/ICH/2997/99 Rev 1 Safety). Completed to the extent that it is applicable for particular N4, N5, C3 and C4 applications, as detailed in Appendix A: Specific mandatory requirements (Module 4).
• Module 5: ICH M4E Common technical document for the registration of pharmaceuticals for human use - Efficacy (CPMP/ICH/2887/99 Rev 1 Efficacy). Completed to the extent that it is applicable for particular N4, N5, C3 and C4 applications, as detailed in Appendix A: Specific mandatory requirements (Module 5).

The application dossier must be submitted electronically, in accordance with the requirements in the General dossier requirements.

Content of the application dossier

The application dossier must provide appropriate documentation (in the correct format and locations, as determined by the CTD modules) to allow a delegate of the Secretary to decide whether the medicine can be approved for registration on the Australian Register of Therapeutic Goods (ARTG). The exact content of the application dossier will vary according to the application level and type of medicine.

Technical data requirements

The technical information that is required in Module 2, 3, 4 and 5 for an application to be considered effective is at Appendix A - Specific technical data requirements.

Where an application meets the description of more than one of the application types listed in Appendix A - Specific technical data requirements, data must be provided in accordance with the requirements for each application type that is relevant to the application.

Australia-specific and adopted European Union and ICH guidelines

It is the applicant's responsibility to identify and familiarise themselves with the relevant Australia-specific guidelines and adopted European Union (EU) and ICH guidelines.

The use of European Union (EU) and ICH guidelines adopted in Australia and other Australia-specific guidelines is not mandated in the legislation. However, under paragraph 25(1)(d) of the Act the delegate is required, when evaluating an application for registration, to consider:

"…whether the quality, safety, and efficacy of the goods for the purposes for which [the goods] are to be used have been satisfactorily established."

Australia-specific guidelines and adopted EU and ICH guidelines describe the kind of data and information to be included in each Module of a dossier to demonstrate quality, safety, and efficacy. If the dossier does not contain all of this information, the TGA may not be able to determine whether the quality, safety and efficacy of the medicine has been satisfactorily established.

Justification for not complying with technical data requirements and not adhering to guidelines

Compliance with relevant requirements set out in Appendix A - Specific technical data requirements and adherence to applicable guidelines is highly desirable as it most readily allows the TGA to come to a view as to whether the medicine can be registered on the ARTG.

Where there are any deviations from relevant requirements or applicable guidelines, the applicant must advise the TGA and provide a justification.

When a justification needs to be provided

If the application does not meet a specific technical requirement or does not adhere to an applicable guideline, a justification must be provided.

For instance, a justification must be provided when:

• The dossier does not contain a Module that is required for the application to be considered effective and accepted for evaluation.
• The application does not adhere, either in full or in part, to the guidelines that set out the required technical information.

What needs to be included in a justification

Where the TGA has provided detailed information to assist applicants to construct a justification, ensure all details have been addressed in the justification. For example, the TGA Biopharmaceutic studies guideline provides information on the required content for a justification for not conducting biopharmaceutic studies.

In other cases, applicants need to make a separate robust scientific justification for each deviation from relevant data requirements or applicable guidelines. The justification must include all of the following for the application to be effective:

• the requirement, guideline or part of the guideline that is not being met must be identified and explain how it is not being met
• detail of the proposed alternative approach and a contemporary scientific justification for why the approach is valid, with reference to supporting documents
• citations of the relevant reference documents, including TGA documents, where appropriate
• literature based submissions must be in accordance with TGA guidance on Literature based submissions and the OTC medicines - Safety and efficacy data
• copies of all cited references documents (other than TGA documents) in the dossier.

Purpose of the justification

Each justification performs two functions:

• It needs to be present and address all of the above points for each relevant requirement that is not met or applicable guideline that is not adhered to, in order for the application to be considered effective under section 23 of the Act and be accepted by the TGA for evaluation.
• Once the application has been accepted for evaluation, each justification needs to be sufficient for the TGA to be satisfied that the medicine can be registered on the ARTG. The content and merit of a justification (i.e. whether the alternative approach is in fact valid) will be assessed during the evaluation phase.

Compliance with administrative requirements

Applicants must comply with, and cannot provide a justification for not complying with, administrative requirements as set out in:

• this document; Organisation and format of the application dossier
• CTD Module 1: OTC medicines
• General dossier requirements.
• the approved application forms in TGA Business Services.