The TGA is seeking your views on the need for the Therapeutic Goods Administration (TGA) to remake the legislative instrument which provides for the lawful public release under the Therapeutic Goods Act 1989 of summary information about Australian recall actions.
The Therapeutic Goods Information (System for Australian Recall Actions) Specification 2013 (‘the SARA Specification’) supports the release of this information from the System for Australian Recall Actions (SARA) database situated on the TGA website and is scheduled to ‘sunset’ (ie cease to have legal effect) on 1 April 2023. Given the broad acceptance of SARA’s benefits since its inception, which have been reinforced during more recent stakeholder consultations as part of the TGA’s Recall Reforms Program, the TGA considers there is a genuine ongoing need for this Specification.
It is their proposal to remake the specification without any significant amendments or changes to the type and amount of information which is currently released.
Background
The SARA database was created in 2012 to improve the transparency of publicly available information about Australian recall actions for therapeutic goods on the TGA website. SARA has provided (and continues to provide) a number of benefits for a broad range of key external stakeholders including therapeutic goods sponsors and manufacturers, consumers, patients, patient support organisations, healthcare professionals and other regulatory agencies by providing access to this summary information. These benefits include –
· Enhanced public safety outcomes, through the provision of recall action data which enables the identification and removal of therapeutic goods from the supply chain, through the conduct of stock and audit reconciliation (e.g. hospitals)
· reduced regulatory burden through having ready access to recall action data in a self-service manner and
· enhanced stakeholder relationships by satisfying the expectation from external stakeholders that critical TGA data sets are available for their use and by providing improved transparency and fast tracking of critical public health and safety information.
In July 2020, following requests from external stakeholders to have access to large volumes of raw recall action data from SARA, we launched a new feature which allows users to extract individual search data into editable MS Excel spreadsheets for all of the existing, publicly available data. Previously this data could only be downloaded as PDF reports. This enhancement has provided better access, transparency and a further reduction of regulatory burden through users acquiring improved ‘self-serve’ access to large volumes of recall action data. It further recognises and supports stakeholder expectations that critical TGA data sets are readily accessible.
Required action
If you have any comments on the TGA’s proposal to remake the SARA Specification without any significant amendments or changes, please send your responses to recalls.reforms@health.gov.au by no later than close of business Friday, 10 February 2023. Any feedback you provide will be taken into account as part of the TGA’s considerations to remake the SARA Specification.
