The reforms will result in new medicines coming to market sooner in Australia, while maintaining a framework for safety, quality and efficacy. This will be achieved by making greater use of assessments from comparable overseas regulators and introducing expedited and provisional approval pathways for new medicines in certain circumstances. To increase flexibility for industry and decrease approval times, several new pathways for registering medicines will be implemented:

• Work-sharing arrangements with comparable overseas regulators;
• Increased use of assessments done by comparable overseas regulators; and
• Implementation of expedited and provisional approvals in appropriate circumstances

Reforms to the regulation of medicines will also include adopting a more risk-based approach to the regulation of variations to existing medicines. In addition, a support service to assist Small and Medium sized Enterprises to navigate regulatory processes will be established, along with improved regulatory guidance information.

A detailed assessment of the effort required for the different pathways for new applications and variations will be carried out, and fees for the new pathways will be proposed. After consultation with industry, a Cost Recovery Impact Statement and a new fees schedule will be developed for Government consideration.

Worksharing

Number of prescription medicines on the ARTG

The existing process for registering new chemical, biological and generic medicines, where the sponsor submits a complete dossier for assessment to be undertaken in full by the TGA, will be maintained and continue to be enhanced through business process improvements.

In addition, a variant that includes the option of a worksharing arrangement between the TGA and a comparable overseas regulator will be implemented. The worksharing approach would allow the two regulators to work simultaneously on different parts of the dossier (e.g. clinical module 5 and the various non-clinical and quality modules 2-4) for a new medicine. These evaluation reports would be provided to decision makers in both countries. This approach is still in the very early stages of development globally and requires active interest and cooperation from other regulators. TGA will continue efforts to put in place worksharing arrangements over the next few years.

Submission of an un-redacted evaluation report from a comparable overseas regulator

This pathway involves submission of an un-redacted evaluation report from a comparable overseas regulator by the sponsor, along with a copy of the dossier submitted to that regulator and an Australian-specific Module 1, for assessment by the TGA. The medicine that the sponsor is seeking to register in the Australian Register of Therapeutic Goods (ARTG) must be identical to the product approved by the overseas regulator. This pathway will be available for new chemical, biological and generic medicines.

The TGA would make a decision on registration of the medicine once it has considered the data within the Australian context.

In order to utilise this pathway for a new medicine the sponsor would be required to submit:

• A full application in Common Technical Document (CTD) format including Module 1 (administrative) of the CTD describing the administrative information and prescribing information (including proposed product information and labelling) for Australia;
• An un-redacted copy of all evaluation reports, in English, completed by the comparable overseas regulator;
• Evidence that:
  • The medicine is identical to the one approved by the comparable overseas regulator (i.e. same dosage form, strength, formulation and indications);
  • The medicine will be manufactured by the same manufacturer as the medicine approved by the overseas regulator;
  • The manufacturing process to produce the medicine will be identical to that assessed by the comparable overseas regulator; and
  • There are no specific issues regarding applicability of the product to the Australian clinical context.
• Details of the outcomes of the application in all jurisdictions where it has been submitted (noting that this is a current requirement); and
• Appropriate certifications and/or authentication of reports.

The TGA would evaluate the application in an abbreviated manner to:

• Verify that the necessary certifications outlined above are correct;
• Ensure that the medicine is fit for the Australian population and conditions; taking into account factors such as demographics, climatic conditions, disease epidemiology, and clinical practice;
• Verify that the post-market risk management tools proposed for the medicine are appropriate considering Australia's specific clinical environment; and
• Ensure proposed product labelling, Product Information and Consumer Medicine Information are consistent with Australian requirements.

Benefits of this pathway are that new chemical, biological and generic medicines could come to the market up to four months sooner.

Priority review of new chemical and biological medicines

In consultation with consumers, health professionals and industry, the TGA will develop criteria under which applications for expedited approval of a medicine may be made. It is anticipated that the factors to be taken into consideration would include:

• The seriousness of the disease or condition to be treated by the medicine and its impact on people’s daily lives;
• The existence of alternative effective interventions; and
• The extent of innovation offered by the medicine - i.e. will it provide a substantial benefit to patient outcomes?

Sponsors will also be able to use un-redacted overseas evaluation reports for the expedited approval pathway. The decision on whether a particular medicine is accepted for expedited review would be made by the TGA based on these criteria.

Provisional approval

This approach aims to allow medicines to reach patients with unmet clinical needs earlier than might otherwise be the case, by allowing medicines to be registered on the basis of surrogate end points or other relevant data, rather than on patient safety and efficacy data from full Phase III trials. Full non-clinical modules would still be required in the submission. This would allow for the TGA to provide provisional registration of a medicine in the ARTG in the absence of full Phase III trial safety and efficacy data, where the benefit to public health of the immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required.

Provisional approvals for marketing in Australia will be limited in duration. The sponsor will also be required to meet conditions imposed by the TGA. For example, a requirement will be for the sponsor to provide post-market efficacy and safety data to substantiate a request for renewal of provisional approval or for a subsequent application for ongoing approval.

When enough data on the medicine is provided to confirm adequate safety, and efficacy standards, the medicine could then receive full registration. If the required data cannot be provided within the required timeframe then the provisional approval may either be cancelled or possibly extended.

Benefits of priority review and provisional approval include:

• Sponsors will have a choice of alternative pathways.
• Alignment with other overseas regulators that offer expedited approval.
• The pathways will provide consumers and health professionals with faster access to new medicines. In the case of priority review, new medicines could come to market 3 months sooner and for provisional approvals, as much as 2 years sooner than under the current framework.
• Provisional approvals will also be available for extension of indications to certain medicines at the discretion of the TGA.

Variations to medicines already on the ARTG

A more risk-based approach to the management of variations to medicines registered in the ARTG will provide for:

• Notification of variations to the TGA in circumstances where the variation does not impact the quality, safety or efficacy of the medicine. The sponsor will be required to notify the TGA of the variation within a given timeframe.
• Assessment of the variation by the TGA in circumstances where the variation has the potential to impact the safety, quality or efficacy of the medicine.
• Electronic submission of data supporting notifications of (or requests for) variations.

A list of variations that are acceptable for notification only will be developed, with the general aim of alignment with European Medicines Agency requirements.

Benefits of new variation processes include:

• Significant reduction in regulatory burden and time to effect the variation by moving certain variations to a notification process.
• Reduction in unnecessary assessment work by the TGA.

Improved post-market surveillance

In conjunction with reforms to increase flexibility and reduce approval times, more extensive post-market and pharmacovigilance activities will be carried out to ensure medicines are appropriately monitored for safety, quality and efficacy.

These will seek to further support and enhance the current post-market monitoring framework in Australia, and include:

• System improvements and enhancements to enable greater collection of adverse events information. This will include the use of reporting systems that can be integrated with prescribing software, and enable streamlined reporting of adverse events to the TGA, as well as improve data analytics through linking with other data (such as PBS utilisation data and MBS item number);
• Improvements to the capability to undertake signal detection, drawing from adverse events information, monitoring international evidence and literature, and working with overseas regulators. This will include greater regulatory cooperation and information sharing, and increase the capability of the TGA to readily respond to any issues around problems with medicines, and through this improve patient safety;
• 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;
• Consultation with professional advisory groups, such as the Advisory Committee on Medicines and the Advisory Committee on Vaccines on issues related to the safety, detection, assessment and prevention of adverse events relates to medicines and vaccines.

These reforms will help the TGA to manage the quality, safety and efficacy of medicines in Australia, while recognising the need to ensure timely and appropriate access to medicines that can improve patient health outcomes.