Implement international harmonisation and Enhanced cooperation and work sharing, work sharing activities with comparable including increased reliance on medicines international regulators. evaluation and facilities inspection information from international regulators, as outlined in TGA’s International Engagement Strategy 2016-2018. 2015-16 2016-17 2017-18 2018-19 2019-20 Quantitative performance criteria Target Target Target Target Target Percentage of good manufacturing practice clearances of overseas manufacturers that take into 85% 85% 85% 85% 85% account approvals by equivalent international regulators. Program objective C. Promoting best practice regulation of therapeutic In 2016-17, the TGA will continue implementation of a comprehensive reform agenda that will optimise a range of regulatory processes and improve the way the TGA communicates with the public about the benefits and risks of therapeutic goods. The TGA will continue to identify opportunities and implement action to reduce regulatory burden on industry, consistent with the Government’s regulatory reform agenda, while continuing to meet the objectives of safeguarding and enhancing the health of the Australian community. Based on the Government’s response to the Expert Panel Review of Medicines and Medical Devices Regulation, the Department will begin design and implementation of the agreed reforms. Qualitative performance criteria 2016-17 Reference point or target Implement reforms that enhance TGA’s current Begin implementation of the Government’s regulatory processes and are consistent with the response to the Review of Medicines and Medical Government's regulatory reform agenda. Devices Regulation. Program objective D. Regulating the import, export, and manufacture of controlled The Office of Drug Control (ODC) will administer a licensing and permit regime for import, export and manufacture of controlled in line with Australian legislation and international conventions, to ensure access to essential medications while supporting Government policy on harm minimisation and harm reduction. Qualitative performance criteria 2016-17 Reference point or target Provide timely and quality advice to meet Timely response to requests for data and Australia’s reporting obligations the completion of quarterly and annual reports. International Narcotic Drugs Conventions. 2015-16 2016-17 2017-18 2018-19 2019-20 Quantitative performance criteria Target Target Target Target Target
Implement international harmonisation and work sharing activities with comparable international regulators. Enhanced cooperation and work sharing, including increased reliance on medicines evaluation and facilities inspection information from international regulators, as outlined in TGA’s International Engagement Strategy 2016-2018. Quantitative performance criteria 2015-16 Target 2016-17 Target 2017-18 Target 2018-19 Target 2019-20 Target Percentage of good manufacturing practice clearances of overseas manufacturers that take into account approvals by equivalent international regulators. 85% 85% 85% 85% 85% Program objective C. Promoting best practice regulation of therapeutic In 2016-17, the TGA will continue implementation of a comprehensive reform agenda that will optimise a range of regulatory processes and improve the way the TGA communicates with the public about the benefits and risks of therapeutic goods. The TGA will continue to identify opportunities and implement action to reduce regulatory burden on industry, consistent with the Government’s regulatory reform agenda, while continuing to meet the objectives of safeguarding and enhancing the health of the Australian community. Based on the Government’s response to the Expert Panel Review of Medicines and Medical Devices Regulation, the Department will begin design and implementation of the agreed reforms. Qualitative performance criteria 2016-17 Reference point or target Implement reforms that enhance TGA’s current regulatory processes and are consistent with the Government's regulatory reform agenda. Begin implementation of the Government’s response to the Review of Medicines and Medical Devices Regulation. Program objective D. Regulating the import, export, and manufacture of controlled The Office of Drug Control (ODC) will administer a licensing and permit regime for import, export and manufacture of controlled in line with Australian legislation and international conventions, to ensure access to essential medications while supporting Government policy on harm minimisation and harm reduction. Qualitative performance criteria 2016-17 Reference point or target Provide timely and quality advice to meet Australia’s reporting obligations the International Narcotic Drugs Conventions. Timely response to requests for data and completion of quarterly and annual reports. Quantitative performance criteria 2015-16 Target 2016-17 Target 2017-18 Target 2018-19 Target 2019-20 Target
2016-17_Health_PBS_2.05_Outcome_5.docx