Applications_–_Sequences_–_Regulatory

Applications – Sequences – Regulatory Activities

In eCTD terms, an application is “A collection of documents compiled by a pharmaceutical company or its agent in compliance with… legislation and guidelines in order to seek a marketing authorization or any amendments thereof.”(Reference 7) An application is also sometimes called a dossier.

An application always has a unique Application Number. In Europe, the Application Number is not always known in advance and a temporary identifier must often be used until the official number is issued.

A sequence is “a single set of information and/or documents supplied by the applicant as a part of, or the complete, Application.” (Reference 7) A sequence will always have a four digit sequence number. An application initially consists of a single sequence (the original application) and over time may grow to include dozens or even hundreds of sequences. A sequence is sometimes referred to as a “submission”, but this is a somewhat ambiguous term as in some markets (such as Health Canada) where a submission is equivalent to an application.

Sequences are organized into regulatory activities. A regulatory activity is “a collection of sequences covering the start to the end of a specific business process, e.g., an initial MA application or Type II variation.” (Reference 7) In the US, it is used to organize documentation related to an original application or supplement into a single unit for review and approval.

GlobalSubmit PUBLISH is used to create and maintain eCTD applications including:

• Adding, editing, and maintaining sequences

• Organizing sequences into regulatory activities