Making labels more effective

The TGA has commenced a new project to broadly review the labelling requirements for medicines and the processes we use to determine labelling requirements.

There is a need to take action to rectify problems such as the complexity for sponsors. The National Drugs and Poisons Scheduling Committee (NDPSC) has requested that TGA consider the issues involved in moving warnings from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) to the auspices of the TGA. Options for change have to be in keeping with harmonisation with New Zealand and the Review of Drugs, Poisons and Controlled Substances legislation currently underway.

The project will also examine labelling issues that emerged during the review of analgesics, such as the role of TGA in maintaining warning requirements in the registration of medicines and the effectiveness of label design in reducing risks and promoting quality use.

This project is necessarily broader than the concurrent review of TGO 48 (Labelling Order). It will involve another look at all the sources of labelling requirements and their interrelationships.

Any reforms must be consistent with the safety and quality use objectives for both prescription and nonprescription medicines. All regulation must meet tests of consumer benefit, cost-effectiveness and challenges arising from national uniformity and harmonisation objectives. We must also take account of concurrent changes to advertising regulation and the listing process.

To start the project, an internal TGA core team is determining the boundaries, current problems to be addressed and options for change - with a twelve-month timeframe and limited budget. Broad consultation on a discussion paper is expected to commence early next year.