Proposed changes to support automated decision making (ADM) for applications to change listed medicines

Overview

Proposed changes to support automated decision making (ADM) for applications to change listed medicines

Medicines listed in the Australian Register of Therapeutic Goods (ARTG) under section 26A of the Therapeutic Goods Act 1989 (the Act) are included in the ARTG without pre-market assessment by the Therapeutic Goods Administration (TGA). These medicines are self-listed by the applicant (who becomes the sponsor), or an authorised representative on behalf of a sponsor (such as a regulatory affairs agent) through the TGA Business Services (TBS) system.

Once listed, section 9D of the Act permits sponsors to request the Secretary’s approval to vary (change) certain information in the ARTG entry for their medicine, provided, in general, that the proposed variation would not make the new entry ‘separate and distinct’ from the existing ARTG entry.

In most circumstances, decisions on proposed variations for listed medicines are made by the TBS system via an Automated Decision Making (ADM) process [namely, decisions made under section 9D of the Act excluding subsection 9D(1)]. The TBS system also determines via an ADM process where a proposed change to an existing listed medicine requires a new listing to be created under s 23 of the Act.

This consultation identifies legislative provisions, definitions and guidance that are not clear or transparent in relation to variations and other changes that can be made for listed medicines. The TGA is seeking feedback on proposed approaches to provide greater transparency and certainty regarding automated decision-making in relation to proposed variations (and other changes) for listed medicines.

The specific matters under consideration include clarifying the following:

• guidance for changing the information about listed medicines in the ARTG
• the legislative basis for variation decisions subject to ADM
• the term ‘restricted ingredient’ and its scope concerning permitted ingredients in relation to when changes to a listed medicine would be considered to create a separate and distinct entry in the ARTG.

The issues and proposed changes are detailed in the Consultation document at the bottom of this page.

To respond to this consultation please click the 'Online Survey' link below. The questions posed in the Consultation document are replicated in the Online Survey.

You can respond to any or all of the proposed changes. Responses can be entered directly into the text boxes provided for each question, or submitted as a single PDF or Word document upload. 

Privacy and your personal information

The TGA collects your personal information in this submission in order to:

1. Clarify any issues raised in your submission or to confirm whether you consent to certain information being made publicly available.
2. Help provide context about your submission. For example, whether you are responding as an individual, a director of a company or representing an interest group.

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means, information or an opinion about an identified individual, or an individual who is reasonably identifiable, from the information or opinion. The TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

Online publication of submissions

The TGA may disclose your full name, work title, company/organisation and submission on the Internet (i.e. make this information publicly available) with your consent.

You may specify whether there is anything in your submission which you would prefer to not be published online (e.g. names, email addresses, proprietary information) by:

1. Providing an additional, redacted copy of your submission; or
2. Providing details of content not to be published e.g. “Do not publish pages 3-5”, “Please redact contact details”; or
3. Identifying any text within your submission to remain confidential by having it clearly marked 'IN CONFIDENCE' and highlighted in grey.

Why your views matter

The TGA is requesting feedback to help ensure there is clarity, transparency and certainty regarding automated decision-making, and more broadly, the regulatory pathways, relating to applications to change information about listed medicines in the ARTG.