The changes introduce additional pathways for registering medicines. Additional pathways will be developed which:

• enable greater use of assessments from comparable overseas regulators for new chemical entities, generics and biosimilars
• establish work-sharing arrangements with comparable overseas regulators for new chemical entities, generics and biosimilars
• introduce expedited approval pathways for new medicines in certain circumstances
• allow certain medicines to be provisionally approved in appropriate circumstances

Existing processes, where the sponsor submits a complete dossier which is assessed in full by the TGA, will continue.

Creating additional pathways for registering prescription medicines provides greater efficiency without lowering the standard of regulation in Australia. Increasing the number of pathways will result in new medicines coming to market sooner - benefiting consumers, health professionals and industry.

No. The intention of introducing new pathways is to facilitate medicines coming to market more quickly in Australia and reduce burden for industry. The TGA will retain responsibility for approving therapeutic goods in the Australian Register of Therapeutic Goods (ARTG).

Greater focus will be placed on post-market monitoring activities so that medicines continue to be are appropriately monitored for safety, quality and efficacy. Activities will include:

• Integration of health datasets to facilitate improved analysis of post-market data for therapeutic goods.
• Improved capability for detection of potential safety "signals", drawing from adverse events information, monitoring international evidence and literature, and working with overseas regulators
• Improved monitoring of Risk Management Plans which form part of the approval of some medicines and include activities to be undertaken (such as patient or prescriber education) to support patient safety

Initially the pharmaceutical company making the application will propose which pathway they plan to follow. The TGA would ensure that all the criteria for assessment via a particular pathway had been met before the application could be accepted.

Alternative pathways along the lines proposed in the review report are available in a number of other countries. Work-sharing - where two regulators work on different parts of the assessment dossier - is still in its very early stages of development globally. The TGA has been actively involved in work-sharing and will continue efforts to put in place work-sharing arrangements with other regulators.

Criteria will need to be developed for identifying those overseas regulators we can work-share with, and those with assessments that can be used by the TGA. The review highlights some of the considerations that might be taken into account when working out these criteria.

The TGA and product commercial sponsors will need to develop an understanding of processes undertaken by comparable overseas regulators and determine how to align processes to enable target timeframes to be met. IT Platforms will need to be enhanced for the exchange of confidential information.

Criteria will also need to be developed under which expedited approval of a medicine may be made. These criteria will be developed by the TGA in consultation with consumers, health professionals and industry. Consultation will also be undertaken on the criteria for meeting provisional approval. As indicated, additional conditions will be imposed on provisional approvals including sponsors providing post-market data to substantiate continuing approval.

It is important that the new accelerated pathways do not divert resources from established pathways, so they will need to be resourced accordingly.

A risk-based approach to variations to medicines will be implemented which allows for notification of the variation to the TGA where the variation does not impact on the quality, safety or efficacy of the medicine.

Moving certain variations to a notification process will reduce regulatory burden and time. It will also reduce unnecessary assessment work by the TGA.

Yes, for example by the European Medicines Agency.

Alignment with the European Medicines Agency's requirements for variations that are acceptable for notification only, will be considered with a view to generally aligning with European Medicines Agency requirements.

The reforms will be progressively rolled out by the TGA over the next 18 to 24 months, with new regulatory pathways for some medicines in place within 12 months.

• Fact sheet: Prescription medicines regulatory reforms
• Fact sheets on other reforms are available