THE Society of Hospital Pharmacists of Australia (SHPA) has supported the concept of full and open transparency on the part of the Therapeutic Goods Administration (TGA) in its submission to the TGA relating to 'Expedited pathways for prescription medicines'.
"SHPA believes that TGA decisions should be published as soon as possible with as much detail as possible, to support the notion that these are transparent process and consolidate the consumer and industry confidence that the TGA holds," the submission reads.
Further, the hospital pharmacy group said that on a local level the publication of assessment reports and rationale for regulatory decisions would also be pertinent information for Drug and Therapeutic Committees (DTC) and Medication Advisory Committees (MAC) of health service facilities.
This will inform their decisions when considering additions and amendments to formularies, individual patient usage applications, as well as stewardship and governance activities.
"Making such information available to DTCs and MACs would also aid in the detection and reporting of adverse events and contribute to post-market surveillance activities," the Society said.
In addition, the SHPA said it believed it was important that the TGA made objective determinations as to what constituted a 'major' therapeutic advantage, when such claims were made by sponsors seeking priority review and provisional approval.
Objective measures suggested by the SHPA were decreases/increases in biological markers, length of remission periods or improved scores for clinically validated tools such as cognition or movement tests - submissions at tga.gov.au.
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