Glossary of terms for electronic Common Technical Document (eCTD)

eSubmission (electronic submission)

An eSubmission presents information to us electronically. eSubmissions are standardised and paperless.

eCTD format

The eCTD format is a worldwide standard for sending us your eSubmission. The eCTD format:

• organises main documents in PDF format and contains an XML file that acts like a table of contents

• uses MD5 Checksum to make sure the files haven’t been altered when transferred to us

• ensures information remains up to date by using lifecycle management tools.

eCTD dossier

An eCTD dossier (also known as 'dossier'), is a collection of electronic documents that are:

• filed under an e-Identifier (e-ID)

• made up of a number of sequences and regulatory activities.

eCTD specification

An eCTD specification is a detailed set of guidelines and requirements for structuring your eCTD sequence, consisting of:

• optional style sheets - also known as templates

• schema - structure sequence data

• codes and defined lists - outline the allowable terms for populating your sequence

• matrices - outline appropriate combinations of documents and codes

• validation criteria – a set of rules your dossier must conform to.

eCTD lifecycle

The eCTD lifecycle is the process of managing electronic submissions for a product to ensure information remains up to date, by adding new documents, replacing outdated documents, and deleting non-relevant information.

Regulatory activity (submission)

A regulatory activity is a collection of sequences covering a specific request. In Australia, this is also known as a 'submission'. For example: Submission for a New Chemical Entity (NCE).

Depending on the complexity of the activity, a regulatory activity may consist of multiple sequences. Table 1 shows a regulatory activity with six sequences.

Stream

A Stream refers to the clinical team that will deal with a regulatory activity. Each stream corresponds to a therapeutic category. For more information, read Prescription medicine clinical units.

eCTD sequence

An eCTD sequence is a set of documents submitted to us as part of a regulatory submission.

e-ID

An e-ID is the unique identifier for an eCTD dossier. An e-ID:

• tracks the included products throughout their lifecycle

• is made up of a combination of a letter and 6 digits (e.g. e123456).

Sequence number

A sequence number consists of 4 digits. As shown in the second column in Table 1, the first sequence number is usually '0000'. Further submissions are automatically generated in sequential order.

Related sequence number

As shown in the third column of Table 1, the related sequence number is used to group sequences relating to a regulatory activity.

Regulatory activity lead

As shown in the fourth column of Table 1, the regulatory activity lead is the group who will lead the review process.

Sequence type

As shown in the fifth column in Table 1, the sequence type defines the purpose for submitting the sequence.

Sequence description

As shown in the sixth column in Table 1, the sequence description identifies the type of document you are submitting.

To choose the most appropriate sequence type and description, use the lists in eCTD specifications.

If you are unsure which sequence type or description to use, email us at eSubmissions@health.gov.au.

Document matrix

The document matrix outlines the minimum document requirements for each sequence type.

Sequence matrix

The sequence matrix defines which sequence types and sequence descriptions can be used together. This ensures only valid combinations are used.

XML envelope

The XML envelope is the basic architecture of the eCTD. It contains important information for sequence processing and categorising known as metadata. We use this information to:

• file the sequence within the correct location in our dossier management system

• determine the evaluation pathway

• contact you if we have any validation questions.

Leaf

The leaf is the structural element of an eCTD submission delivering a document. It provides the link information to the document along with the title associated with the linked content.

Therapeutic area prefix

The therapeutic area prefix is a 2-digit code that indicates the type of product or data being submitted.

The product prefixes are:

• PM for prescription medicines

• BA for biologicals

• OM for over-the-counter medicines and registered complementary medicines

• MD for medical devices.

The data prefixes are:

• PV for pharmacovigilance

• MF for master files.

Nees (Non-eCTD electronic submission)

NeeS is an alternative way to submit data electronically. See NeeS guidance and specification.

For help submitting a sequence, email eSubmissions@health.gov.au.

For help with eCTD specifications, email EDR@health.gov.au.