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The Business Improvement Program
The Therapeutic Goods Administration (TGA) introduced the Business Improvement Program (BIP) to make our information and communications technologies better. We consider that by providing improved services we will continue to meet the needs of consumers, health professionals and industry.
The program was initially scheduled to be completed in 2016 but was extended by a year to address changes in our operating environment. The majority of the projects were achieved before the end of 2017.
Work on three projects continues. Two were improved and rolled into similar Medicines Medical Devices Regulation Review (MMDR) projects. The third project had some technical problems which are being fixed. It is expected that all three projects will be delivered in 2018.
What was achieved?
|Enhanced Manufacturer Quality and Recalls Capability (EMQRC)||Moved to a standalone project: 'GMP Clearance Solution' project which has now been completed with the solution becoming live on the TGA Business Services portal in 2017.|
|Business and IT Integration - including a new business portal and Ingredients Repository||TGA Business Services forms a base for electronic commerce, electronic lodgement of data packages in support of applications for entry of products onto the Australian Register of Therapeutic Goods and allows online client access to legally appropriate information.|
|electronic Common Technical Dossier (eCTD)||The TGA started receiving and managing electronic submissions for prescription medicine applications in June 2015.|
|Prescription Medicine Minor Variations (PMMV)||An eForm to support applications for minor variations to prescription medicines was in use since July 2017.|
To be delivered in 2018
|Adverse Event Management System (AEMS)||Became part of the MMDR implementation - 'IT enhanced post-market monitoring and analytics' project.|
|Special Access Scheme (SAS): Unapproved Therapeutic Goods||Moved to the MMDR to become an integrated online system for management of SAS applications.|
|Conformity Assessment eForm||An eForm to support Conformity Assessment medical device applications is being finalised. The eForm had a limited release for user testing. It was well received however it still requires work to resolve the issues that were encountered.|