Module 2 Category 1/2 applications, fee type A, B C and D
| TGA's application fee type is … | A - NCE | B - New Combination | C – Extension of indication | D – New generic medicine | |||
|---|---|---|---|---|---|---|---|
| Applying for a … | New chemical entity | New salt or ester of existing active ingredient | Similar biological medicinal product | ||||
| Module 2.1 | Table of contents | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 2.2 | Introduction | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 2.3 | Quality overall summary | Mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 2.4 | Nonclinical overview | Mandatory | Mandatory | Mandatory | Mandatory | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.5 | Clinical overview | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 2.6 | Nonclinical overview | Mandatory | Mandatory | Mandatory | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.7 | Clinical overview | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | May be required. Refer to part A of this document for Module 1 requirements. |
Module 2 Category 1/2 applications, fee type E, F and J
| TGA's application fee type is … | F - Major variation | E - Additional tradename | J - PI Change requiring evaluation | |||||
|---|---|---|---|---|---|---|---|---|
| Applying for a … | New strength | New dosage form | New route of administration | Change in patient group (not decrese) | Change of dosage | |||
| Module 2.1 | Table of contents | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.2 | Introduction | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.3 | Quality overall summary | Mandatory | Mandatory | May be required. Refer to part A of this document for Module 1 requirements. | Not required | Not required | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.4 | Nonclinical overview | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.5 | Clinical overview | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.6 | Nonclinical overview | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.7 | Clinical overview | May be required. Refer to part A of this document for Module 1 requirements. | Mandatory | Mandatory | Mandatory | Mandatory | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
Module 2 Category 3 applications, fee type G and H
| TGA's application fee type is … | G - Minor variation, new Register entry | H - Minor variation, not resulting in a new Register Entry | |||
|---|---|---|---|---|---|
| Applying for a … | Change of formulation | New container type | Change of tradename | ||
| Module 2.1 | Table of contents | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.2 | Introduction | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 2.3 | Quality overall summary | Mandatory | Mandatory | Not required | Mandatory |
| Module 2.4 | Nonclinical overview | Not required | Not required | Not required | Not required |
| Module 2.5 | Clinical overview | Not required | Not required | Not required | Not required |
| Module 2.6 | Nonclinical overview | Not required | Not required | Not required | Not required |
| Module 2.7 | Clinical overview | Not required | Not required | Not required | Not required |
Module 3-5 Category 1/2 applications, fee type A, B C and D
| TGA's application fee type is … | A - NCE | B - New Combination | C – Extension of indication | D – New generic medicine | ||
|---|---|---|---|---|---|---|
| Applying for a … | New chemical entity | New salt or ester of existing active ingredient | Similar biological medicinal product | |||
| Module 3—Quality | Mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 4—Nonclinical | Mandatory | Mandatory | Mandatory | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 5—Clinical | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 5.3.1 Reports of biopharmaceutic studies | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 5.3.2 Pharmacokinetic studies using human biomaterials | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required |
Module 3-5 Category 1/2 applications, fee type E, F and J
| TGA's application fee type is … | F - Major variation | E - Additional tradename | J - PI Change requiring evaluation | ||||
|---|---|---|---|---|---|---|---|
| Applying for a … | New strength | New dosage form | New route of administration | Change in patient group (not decrese) | Change of dosage | ||
| Module 3—Quality | Mandatory | Mandatory | May be required. Refer to part A of this document for Module 1 requirements. | Not required | Not required | Not required | Not required |
| Module 4—Nonclinical | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 5—Clinical | May be required. Refer to part A of this document for Module 1 requirements. | Mandatory | Mandatory | Mandatory | Mandatory | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 5.3.1 Reports of biopharmaceutic studies | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
| Module 5.3.2 Pharmacokinetic studies using human biomaterials | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | May be required. Refer to part A of this document for Module 1 requirements. | Not required | May be required. Refer to part A of this document for Module 1 requirements. |
Module 3-5 Category 3 applications, fee type G and H
| TGA's application fee type is … | G - Minor variation, new Register entry | H - Minor variation, not resulting in a new Register Entry | ||
|---|---|---|---|---|
| Applying for a … | Change of formulation | New container type | Change of tradename | |
| Module 3—Quality | Mandatory | Mandatory | Not required | Mandatory |
| Module 4—Nonclinical | Not required | Not required | Not required | Not required |
| Module 5—Clinical | Not required | Not required | Not required | Not required |
| Module 5.3.1 Reports of biopharmaceutic studies | Not required | Not required | Not required | Not required |
| Module 5.3.2 Pharmacokinetic studies using human biomaterials | Not required | Not required | Not required | Not required |
Application types G and H are shown as Caegory 3 application. They may be Cat 1/2 or Cat 3 depending on whether they are supported by clinical, nonclinical or bioavailability data (Cat 1/2) or not (Cat 3). Cat 1/2 G and H are not included in the dossier in the table. If nonclinical (Module 4), clinical (Module 5) or bio-availability (Module 5.3) data are submitted, relevant Module 2 summaries and overviews will be required. Modules 1.8, 1.9 and 1.11 may also be required, depending on the application.
Topics