Regulatory activity category
Regulatory activity category is identified by a number, for example, Category 1 and Comparable Overseas Regulator (COR) report-based applications, and refers to the overall legislated time-frames for decisions about regulatory activities.
Regulatory activity type
Regulatory activity type relates to the fees associated with an application and is identified by a letter, for example, A, B or C applications.
- new chemical entity
- new indication.
A sequence is a package of information bundled together in an electronic structure providing information to the agency. The contents of a sequence will depend on the regulatory activity type and whether it is the initial sequence of the regulatory activity or a follow-up providing additional data or changes (see also Module 1.0.2 Lifecycle tracking table).
Common technical document (CTD)
The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the TGA in 2004.
The CTD prescribes:
- the organisation of the dossier across five modules
- the order in which documents must appear so they are grouped logically and can be easily located.
Under the CTD format:
- Each dossier is a collection of documents grouped into five modules as detailed below.
- The actual content of the dossier will vary according to the regulatory activity: for example, category 1; Type A (new chemical entity) or Type D (new generic medicine).
- The format of Modules 2, 3, 4 and 5 is described in the relevant adopted CTD guidelines.
- There is no single document that explains the content of Module 2. The documents for Modules 3, 4, and 5 include a section on the information that must be provided in Module 2.
- CTD for the registration of pharmaceuticals for human use - Quality overall summary of Module 2 and Module 3: quality
- CTD for the registration of pharmaceuticals for human use - Nonclinical overview and nonclinical summaries of Module 2 and organisation of Module 4
- CTD for the registration of pharmaceuticals for human use - clinical overview and clinical summary of Module 2 and Module 5: clinical study reports
- See also:CTD General (M4)Questions and Answers (R3)
- The content of Modules 3, 4 and 5 (technical data requirements) will vary according to the regulatory activity and is described in the relevant TGA standards & guidelines for prescription medicines.
The format and content of Module 1 (Administrative information and prescribing information for Australia) are described in this document.
The electronic Common Technical Document (eCTD) is the electronic version of the CTD and is described by the following documents: