Boxed warnings consultation


The TGA is looking for submissions regarding the proposed guidance for the use of Boxed Warnings for prescription medicines

The organisation has opened a public consultation paper and is keen to hear from interested individuals and representatives from industry, consumer and health professional groups on the matter.

The paper aims to outline the objectives for introducing a Boxed Warning to a Product Information document; to provide draft guidance on how and when to use a Boxed Warning; and seek feedback from consumers, health care professionals and industry on the proposed requirements for Boxed Warnings.

“This paper focuses on aspects of the Boxed Warning that will inform guidance for industry sponsors intending to, or requested to, include a Boxed Warning statement as part of the Product Information (PI) document,” the paper states.

“In implementing guidance, we will assist sponsors with determining when a Boxed Warning is required and what it should look like, with a view to ensuring consistency across the prescription medicines regulatory framework.

“Different international regulatory agencies have taken varying approaches to the use of Boxed Warnings and they are not used consistently across jurisdictions, adding to the importance of providing guidance in the Australian context.”

Documents for consultation were released on Friday, 10 August and interested parties should respond by close of business on Friday, 31 August 2018.

The TGA is asking stakeholders to state clearly in their submissions whether or not they support the Boxed Warning guidance; they are invited to make suggestions for alternatives should they have them.

Stakeholders are also asked to provide an assessment of how the proposed changes will impact them and what they see as likely cost or benefits to them.

The paper can be downloaded here.

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NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.