The TGA has begun formal consultation on the raft of reforms announced as part of government's response to the review of medicines and medical device regulation.
One of the most anticipated reforms is the introduction of an 'expedited pathway' for prescription medicines.
The pathway will include two processes.
"The Priority Review pathway will prioritise the evaluation of novel prescription medicines that meet the eligibility criteria and have a complete data dossier, with a view to reducing the target timeframe for a decision regarding registration of the medicine in the ARTG. A target timeframe of 150 working days has been recommended for Priority Review, consistent with the benchmarks set by the FDA and EMA for similar programs," says the consultation paper.
The alternative is Provisional Approval, under which medicines will be provisionally registered on the basis of early data on efficacy and safety.
"Medicines will only be provisionally registered in the ARTG where the benefit to public health of earlier availability of the medicine outweighs the risk inherent in the fact that additional clinical data are still required...Provisional registration will be limited in duration and will automatically lapse at the end of a specified period unless sponsors meet the conditions imposed by the TGA," it says.
The paper sets out three criteria for inclusion in the expedited pathway:
- the medicine is indicated for the treatment, prevention or diagnosis of a life threatening or seriously debilitating disease or condition:
- the medicine addresses an unmet clinical need in Australian consumers; and,
- the medicine represents a major therapeutic advantage.
Legislation will be required to implement the expedited pathway.
The regulator is also seeking input on the criteria to identify comparable overseas regulators (CORs) as providers of assessment reports and possible work-sharing partners in the assessment of medicine registration applications.
A consultation paper sets out a range of potential criteria to identity CORs, including a similar regulatory framework, an established formal and robust framework for cooperation with the TGA, use of similar international guidelines and standards, and the ability to conduct their business and release reports in English.
In relation to application-specific criteria, it proposes CORs where identical indications are proposed for a medicine, as well as identical dosage form, strength, formulation and manufacture. In addition, assessment reports are prepared using methodology, guidelines and standards consistent with those used by the TGA, are un-redacted and complete, and the TGA must be able to use assessment reports and any supplementary information generated during the evaluation process as part of Australian Public Assessment Reports.
Stakeholders have until Monday 12 December 2016 to provide input on both consultations.