You are here

CTD Module 1

3 August 2020

Book pagination

1.4 Information about the experts

Overview

This section of Module 1 holds multiple documents providing information about the experts who have reviewed the supporting data for the submission and prepared the summaries and overviews that constitute Module 2.

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.4.1 Quality (if Module 2.3 included) mandatory mandatory mandatory mandatory
1.4.2 Nonclinical (if Module 2.4 included) mandatory mandatory not required not required
1.4.3 Clinical (if Module 2.5 included) mandatory mandatory not required not required

Module 1.4.1 Quality

When to include information about the quality expert

Include where any subsection of Module 2.3 has been provided in the dossier.

How to prepare information about the quality expert

The expert responsible for compiling Module 2.3 must:

  • complete and sign a declaration
  • provide a curriculum vitae (CV) outlining his/her educational background, training and occupational experience.

The following table provides instruction on creating and completing the declaration.

Creating and completing declaration - quality
Expert Instruction
Australian expert

Download the Module 1.4 form Information about the experts and complete the section for the 'Local (Australian) expert' as per the instructions on the form.

The declaration must be signed by the expert who is the subject of the declaration.

Expert from European Union

Provide a copy of the expert's declaration from the application lodged with EMA.

Alternatively, the 'Overseas expert' part of the Module 1.4 form can be completed.

Other overseas expert Complete the 'Overseas expert' part of the Module 1.4 form.

Module 1.4.1 must include, in the following order:

  • the expert's signed declaration (as per the table above), and
  • the expert's curriculum vitae.
Note:

Module 2.3 is required for the following regulatory activity types:

  • new chemical/biological entities, new similar biological medicinal products and new combinations
  • new generics
  • new dosage forms and new strengths
  • any other category 1 or COR report-based application containing Module 3 data.

Module 1.4.2 Nonclinical

When to include information about the nonclinical expert

Include where any subsection of Module 2.4 and/or Module 2.6 has been provided in the dossier.

How to prepare information about the nonclinical expert

The expert(s) responsible for compiling Module 2.4 and Module 2.6 must:

  • complete and sign a declaration
  • provide a curriculum vitae outlining his/her educational background, training, and occupational experience.

The following table provides instruction on creating and completing the declaration.

Creating and completing declaration - nonclinical
Expert Instruction
Australian expert

Download the Module 1.4 Information about the experts form and complete the section for the 'Local (Australian) expert' as per the instructions on the form.

The declaration must be signed by the expert who is the subject of the declaration.

Expert from European Union

Provide a copy of the expert's declaration from the application lodged with EMA.

Alternatively, the 'Overseas expert' part of the Module 1.4 form can be completed.

Other overseas expert Complete the 'Overseas expert' part of the Module 1.4 form.

Module 1.4.2 must include, in the following order:

  • the expert's signed declaration (as per table above), and
  • the expert's curriculum vitae.
Note:

Module 2.4 (nonclinical overview) is required when:

  • nonclinical (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
  • the levels of impurities and degradants exceed guideline recommendations
  • there is a deviation from adopted nonclinical guidelines
  • there are changes to the nonclinical aspects of the Product Information
  • a new generic medicinal product is a new salt, ester, or derivative of a registered active substance and the applicant claims the medicinal product to be essentially similar to the registered product.

Where the applicant claims essentially similarity to a registered product, the nonclinical overview should focus on the grounds for claiming essential similarity and, if applicable, the additional data to demonstrate evidence of the equivalence of safety and efficacy properties of different salts, esters, or derivatives of an authorised active substance are to be provided.

Module 2.6 (nonclinical summary) is required for the following regulatory activity types:

  • ew chemical/biological entities, new similar biological medicinal products and new combinations
  • regulatory activities where new nonclinical studies have been provided in the dossier.

Module 1.4.3 Clinical

When to include information about the clinical expert

Include where any subsection of Module 2.5 and/or Module 2.7 has been provided in the dossier.

How to prepare information about the clinical expert

The expert(s) responsible for compiling Module 2.5 and Module 2.7 must:

  • complete and sign a declaration
  • provide a curriculum vitae outlining his/her educational background, training, and occupational experience.

The following table provides instruction on creating and completing the declaration.

Creating and completing declaration - clinical
Expert Instruction
Australian expert

Download the Module 1.4 Information about the experts form and complete the section for the 'Local (Australian) expert' as per the instructions on the form.

The declaration must be signed by the expert who is the subject of the declaration.

Expert from European Union

Provide a copy of the expert's declaration from the application lodged with EMA.

Alternatively, the 'Overseas expert' part of the Module 1.4 form can be completed.

Other overseas expert Complete the 'Overseas expert' part of the Module 1.4 form.

Module 1.4.3 must include, in the following order:

  • the expert's signed declaration (as per table above), and
  • the expert's curriculum vitae.
Note:

Module 2.5 and Module 2.7 are required for the following regulatory activity types:

  • new chemical/biological entities, new similar biological medicinal products and/or new combinations
  • extensions of indications
  • changes to patient group or dosage and administration
  • regulatory activities where new clinical studies have been provided in the dossier.
Applications to register a new generic medicine

For an application to register a new generic medicine:

  • the clinical overview (Module 2.5) is mandatory
  • clinical summaries (Module 2.7) can be provided, but they are mandatory if new clinical studies have been provided in the dossier
  • where the applicant claims the medicinal product to be essentially similar to a registered product, the clinical overviews/summaries are to focus on the rationale for claiming essential similarity and, if applicable, the additional data to demonstrate evidence of the equivalence of safety and efficacy properties of different salts, esters, or derivatives of an authorised active substance are to be provided.

Book pagination