Prior to submitting a new medicine for registration or listing, TGA require the sponsor to have already submitted GMP Clearance applications for overseas sites involved in the manufacture of the medicine. Once obtained, TGA then expect the sponsor to monitor the expiry dates of these Clearances and to submit renewal applications accordingly, to prevent them from expiring.
GMP Clearances can be obtained via one of three pathways:
- a Mutual Recognition Agreement (MRA) desktop assessment
- a Compliance Verification (CV) desktop assessment
- an on-site inspection by the TGA
The inspection history of the site will determine the applicable pathway, application requirements and TGA evaluation timelines. Understanding TGA’s requirements and a robust process to monitor the expiry dates to submit renewals of GMP Clearances is therefore key to maintaining the product registration.
GMP Clearance challenges
While the principles of GMP Clearance maintenance seem straight forward in submitting information to the TGA to obtain or renew a Clearance, there are an array of variables and challenges that need to be considered to complete them. Understanding the appropriate application pathway, ensuring the required evidence is available and complies with TGA requirements, meeting the required deadline to ensure the approval is obtained without impacting product registration and/or supply and even the format and file naming of the evidence to be supplied to TGA are all examples of the complexities that need to be considered.
Some of these complexities need experience such as understanding TGA’s requirements, others require an initial and ongoing maintenance of a “system” to monitor expiry dates and submission status, but all require time to understand how they fit together to allow the correct process to be followed.
Outsourcing GMP Clearance activities
Commercial Eyes can support sponsors with their GMP Clearance activities to ensure they meet their legal sponsor obligations. Commercial Eyes utilises a purpose-built Salesforce GMP Database to monitor and manage GMP Clearance applications for sponsors. Here are some different options of support models that may benefit sponsors:
Full GMP Clearance support: The most appropriate option for sponsors with limited regulatory presence in Australia. In this scenario, Commercial Eyes will monitor and submit GMP Clearance applications for all sites on behalf of the sponsor. It is a cost-effective option allowing sponsors access to a team of experienced GMP Clearance professionals while paying only for the GMP Clearance activities required throughout the year, rather than ongoing employment costs.
Commercial Eyes liaises directly with the product manufacturers or global contacts and with the TGA, ensuring ongoing compliance with TGA requirements and the project management of all GMP Clearance activities.
Select product/site range/application type support: An ideal option for sponsors with an established regulatory presence in Australia, but with capacity or head count constraints. Sponsors allocate their internal resources to the product range or sites with greater commercial significance or the GMP Clearance application types that are able to be completed by their current team members and outsource the remaining GMP Clearance activities.
Commercial Eyes liaises directly with the product manufacturers or global contacts and with the TGA, ensuring ongoing compliance with TGA requirements and the project management of all GMP Clearance activities for those allocated.
For more information, please contact us at [email protected]
Maria Dionyssopoulos
Head of Regulatory, Quality and Compliance
Maria has extensive experience in developing regulatory strategies and providing insightful regulatory advice to a variety of...
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