Consultation invited on new Therapeutics Regulation

Documents detailing the proposed joint regulatory scheme for the new Australia New Zealand Therapeutic Products Authority (ANZTPA) have recently been released for public consultation.

ANZTPA is inviting submissions on the proposed regulatory scheme or "draft Rules" for medicines and medical devices; a description of the proposed Grouping Order for medicines; draft guidelines on transition provisions for product licensing; the key components of the draft Administration Rule; and the consultation document on the proposed fees and charges.

The closing date for submissions on the consultation documents is 15 August 2006.