One of our Regulatory Consultants, Megan Polidano, attended the 2015 ARCS Scientific Congress session ‘LBS – the options and lessons’ this week. Here is her summary.
The ARCS session on literature based submissions (LBS) provided an overview of the Australian LBS process and outlined the types of products that may be registered via this pathway. The speakers emphasised the importance of pre-submission dialogue with the TGA when developing an LBS strategy and discussed the conduct of a systematic review of the literature. They also stressed the importance of identifying bias in the literature selected to support a LBS.
From a TGA perspective Dr Michael Coory discussed some of the challenges encountered by the evaluators with LBS submissions. These included the submission of an excessive number of studies, the lack of reasoning around safety and efficacy, and a lack of emphasis on post marketing studies.
He recommended that applicants should clearly identify and select the key pivotal studies and that the remainder of the selected studies should be used as supporting information only.
He also addressed the issue of publication bias and indicated that in the future the TGA would expect applicants to search clinicaltrials.gov as often negative study results are unpublished and therefore not appropriately considered in an LBS.
All speakers emphasised that even though compilation of a dossier based on an LBS can be resource and time intensive, this pathway can provide an alternative route for registering new products which contain well established active ingredients.