category 1 applications solely for additional trade names (ATN) Applications for new Register entries made under s. 23 of the Act where the sponsor seeks only to register an ATN for an existing registration. Processes for preparing and lodging submission remain unchanged. For ATN submissions lodged between 1 November 2010 and 28 February 2011 (inclusive), refer to the transitional draft CTD Module 1 - as at September 2010 document. For ATN submissions lodged from 1 March 2011, refer to the transitional draft CTD Module 1 - as at January 2011 document. For details on processes and other regulatory requirements, refer to the . category 1 (other than submissions solely for additional trade names) All other submissions that are either: applications for new Register entries made under s. 23 of the Act to which Regulation 16C applies OR requests for variations under s. 9D(3) of the Act to which Regulation 16D applies. All category 1 submissions, with the exception of ATN applications, lodged with the TGA from 1 November 2010 will be processed through the streamlined submission process (i.e. a planning form (PPF) must be lodged with the TGA between 2½ to 6 months before the submission). For all other category 1 submissions lodged between 1 November 2010 and 28 February 2011 (inclusive), refer to the transitional CTD Module 1 - as at September 2010. For all other category 1 submissions lodged from 1 March 2011, refer to the transitional draft CTD Module 1- as at January 2011 document. For details of processes and other regulatory requirements, refer to the and the documents.
necessarily affect complexity and/or scope could also result in the submission being considered to be not effective. Review any issues identified in the TGA’s pre-submission planning letter for the submission. For each issue in the TGA’s pre-submission planning letter, confirm that it has been addressed and how it was addressed. Prepare a declaration that: Either states that the submission is consistent with the pre-submission planning form lodged OR lists any inconsistencies with appropriate justifications for their inclusion in the submission, and Lists any issues identified as requiring sponsor action in the TGA pre-submission planning letter and identifies how these issues have been addressed. Points to note The TGA will check the submission for consistency with the pre-submission planning form. Extensive differences between the pre-submission planning form and the submission may result in the TGA considering the submission to be not effective i.e. will not be accepted for evaluation. Before lodging a submission with apparent inconsistencies with the corresponding planning form that cannot be readily justified, sponsors are strongly advised to discuss the matter with the Office of Medicines Authorisation to determine the best path. Administrative changes (e.g. correction of spelling errors, repaginations) are not considered to be significant differences. Module 1.9 Individual patient data Overview This section of the module 1 holds information regarding the applicant’s ability to provide individual patient data to support the studies provided in the dossier should the need arise. The following information describes each document in the section, outlines when each document needs to be provided and any other requirements relating to the documents Contents
Part D – Dossier documents matrix Key ● Mandatory ○ Optional – there may be regulatory requirements that determine if it is required. Refer to part B of this document for module 1 requirements. <blank> Not required Category 1 / Category 2 Submissions Category 3 Submission TGA's Submission Fee type is… A - NCE B - New Combination C - EOI D - Generic F - Major Variation E - Additional Tradename J - PI Change requiring evaluation G - Minor Variation, new Register Entry H - Minor variation, not resulting in a new Register Entry Applying for a … New chemical entity New salt or ester of existing active ingredient Biosimilar medicine New Strength New Dosage Form New Route of administration Change in Patient Group (not decrease) Change of Dosage Change of Formulation New Container Type Change of tradename Module 1 Module 1.0.0 Electronic lodgement cover page ● ● ● ● ● Module 1.0.1 Letter of Application (describing change) ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Module 1.0.2 Responses to questions
Module 1.5.1 Literature-based submissions document ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Module 1.5.2 Orphan Drug designation letter ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Module 1.5.3 Genetically Modified Organisms Copy of Consents ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Module 1.5.4 Additional Trade Name Declaration ● Module 1.5.5 Co-marketed Medicines Letter and Declaration ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Module 1.6 Drug and Plasma Master Files and Certificates of Suitability ○ ○ ○ ○ ○ ○ ○ ○ ○ Module 1.7 GMP Clearance ● ● ● ● ● ● ● ● ○ Module 1.8 Compliance with Meetings and processes ● ● ● ● ● ● ● ● ● ● ● ○ ● ○ ○ ○ ○ Module 1.9 Individual Patient Data Declaration ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Module 1.10 Overseas Regulatory Status ● ● ● ● ● ● ○ ● ● ● ● ● Module 1.11 Summary of biopharmaceutic studies ● ● ● ● ○ ○ ● ● ○ ○ Module 1.12 References to Paediatric Dvpt Program ● ● ● ● ● ● ● Module 1.13 Information relating to pharmacovigilance ● ● ○ ● ● ○ ○ ● ○ ○ ○ Module 1 Annex I Antibiotic Resistance Data ○ ○ ○ ○ ○ Module 1 Annex II Overseas Evaluation Reports ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Module 2 Module 2.1 Table of Contents ● ● ● ● ● ● ● ● ● ● ● ○ ○ ○ ○ Module 2.2 Introduction ● ● ● ● ● ● ● ● ● ● ● ○ ○ ○ ○ Module 2.3 Quality Overall Summary ● ● ● ● ● ● ● ○ ○ ○ ○ ○ Module 2.4 Non-clinical Overview ● ● ● ● ○ ○ ○ ○ ○ ○ ○ ○