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Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017

26 April 2018

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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.

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