TGA moves to increase transparency

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Publication of the TGA's prescription medicines annual summary 2015 has revealed a move by the regulator to increase transparency around approval times by including dossier submission and approval dates.

Until now the TGA has only published approval dates. The lack of submission dates has made it impossible to compare TGA approval times with other comparable regulators, including the US FDA and European Medicines Agency.

The annual summary includes dossier submission dates for 35 medicines approved in 2015.

It reveals significant variability in approval times, with many fast approvals, including seven months for Janssen's IMBRUVICA (ibrutininb) for chronic lymphocytic leukaemia, eight months for MSD's KEYTRUDA (pembrolizumab) for melanoma, and ten months for Amgen's BLINCYTO (blinatumomab) for acute lymphoblastic leukaemia.

Yet some approvals took several years.

What appears to be the accelerated approval of some medicines comes as the sector awaits the Government's detailed response to the expert review of the regulation of medicines and medical devices. The response actually received over $20 million in funding in May's Budget but the detail is yet to be released.

The review recommended the adoption of an expedited approval process for breakthrough medicines, allowing sponsors to use submissions to recognised overseas regulators and related evaluation reports, and a review of rescheduling policy and advertising guidelines for S3 medicines.

In his introduction to the annual summary, TGA head Adjunct Professor John Skerritt says it is imperative that Australians have timely access to therapeutic goods.

"To this end, we have endeavoured to streamline our registration processes for prescription medicines. Performance data collected over 2015 has shown that recent reforms have delivered greater overall timeliness and predictability with respect to pre-market registration activities.

"On average, it takes 12 months for the TGA to register a new prescription medicine, having assessed the scientific data available and established that the medicine meets appropriate standards of quality, safety and efficacy.

"The TGA’s approval times for medicines containing new active ingredients are comparable with analogous processes in major jurisdictions such as the US and Europe. This Annual Summary has provided us with an opportunity to increase transparency around our approval times and includes key dates in relation to the registration process for each medicine."