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Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017
Opportunities for continuous improvement
Our self-assessment along with industry feedback provided through the external validation process have assisted us in identifying opportunities for performance improvement in 2017-18. These include:
- delivering extensive formal and informal consultation, improving our consultation by ensuring we target issues identified by industry as significant
- processing applications within target timeframes while providing consistency in decision making
- delivering regulatory information that is clear, targeted and effective through consultation, online publications and other means
- prioritising our compliance and monitoring activity according to identified strategic objectives and collaborating with Commonwealth, state and territory regulators as well as our international counterparts
- providing transparency through regulatory assistance, responses to enquiries and annual reporting
- continuing cooperation across the department as well as with other agencies.
Many of our resources over 2017-18 will be directed at achieving the further implementation of the MMDR reforms, including:
- provisional approval pathway for promising new medicines that do not yet have a full dossier of clinical data
- certain 'low risk' minor variations to prescription medicines to occur via notification
- new pathway where the TGA has assessed efficacy of listed complementary medicines
- online system to manage SAS applications
- removal of pre-approvals for advertising and a single complaints handling function
- broadening of compliance and enforcement powers
- expedited approval pathway for 'novel' medical devices.
Further information about our planned activity is described in the TGA Business Plan 2017-18 and is available on the TGA website.