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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

TGA Responds to Increase in Clearance Docs

Nov 3, 2017, 09:39 AM
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Nov 3, 2017, 08:40 AM

Due to the increase in GMP clearance applications, Australia’s Therapeutic Goods Administration (TGA) is implementing new process improvements. TGA estimates that 60% of clearance applications do not include all the supported evidence necessary to demonstrate that a manufacturing site meets requirements for supplying product to the Australian market. For all applications submitted on or after Sept. 26, TGA will conduct an application assessment once all outstanding fees have been paid. If the assessment finds certain information is missing, the agency will provide a written outline of the deficiencies noted.

Applications submitted before Sept. 26 will have a one-time opportunity for sponsors to submit outstanding supporting information prior to assessment. TGA is also currently working on a revised GMP clearance guidance document and new Web-based Clearance Application Assistance Tool.

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