Comment invited on early warning system for medicines and medical devices

The TGA and Medsafe are running a joint project inviting comment on the trans-Tasman early warning system of safety concerns with medicines and medical devices.

The consultation document, titled ‘The trans-Tasman early warning system: How the process will work in Australia and New Zealand’, contains a description of the proposed process for a parallel early warning system for Australia and New Zealand and includes example web pages.

Example web pages including hypothetical safety communications are included in the consultation. Through the consultation process, the TGA and Medsafe are seeking comments from interested parties on the:

• proposed web pages,
• presentation of the hypothetical examples,
• proposed communication channels.

Feedback will be released following consideration of submissions and responses are invited by the close of business 7 April 2013.

Comments may be made directly or AusBiotech members are invited to submit comments to Alina Tooley, National Manager Programs at atooley@ausbiotech.org or phone +61 3 9828 1425.

For more information and to access the consultation documents, please see here.