GMP clearance application information

Following the April 2024 TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting, CMA requested industry specific information from the Manufacturing Quality Branch (MQB) on GMP clearance applications.   

GMP clearance application delays are occurring due to the backlog of applications and inspections during the COVID-19 pandemic, as well prioritisation of some medicine shortages and other critical medicines/devices. We have been advised that the TGA have recruited a significant number of additional staff within MQB to help address the issue in the short term. For the longer term, CMA are continuing to work with the TGA on reforms to streamline digital applications for clearance applications, and reform the Clearance process for complementary medicines. 

The information provided below is based on the number of Mutual Recognition Agreement (MRA) and Compliance Verification (CV) applications submitted by complementary medicine stakeholders in FY 2022-23: 

  • 93% of MRA applications were approved in FY 2022-23 
  • 100% of CV applications were approved in FY 2022-23 
  • 76% of CV applications were sent a request for information (RFI) by the TGA  
  • 6% of MRA applications were sent a RFI by the TGA 
  • 38% of CV applications received in FY 2022-23 were incomplete. 
Total CM GMP Clearance applications FY 2022-23 
Total applications received 580 
Total applications completed 493 
Approved 425 
Not issued 68 
CM MRA and CV pathway applications FY 2022-23 
MRA approved 165 
MRA not issued 13 
CV approved 27 
CV not issued 

Reducing the number of incomplete applications will also help to reduce the backlog. CMA encourages all members to follow the updated versions at: GMP Clearance Guidance and GMP Clearance Application & Submission User Guide

Tips for timely Clearance applications  

  • Ensuring all your evidence and paperwork as outlined in the Guidance is ready at the time of application;  
  • Ticking the box on the application form to say that the application affects either a current ARTG product or an upcoming application;  
  • Ensuring payment of your portion of an inspection is paid on time. There are issues with delays where one sponsor might not pay in time holding up other sponsors part of the same inspection. This particularly occurs where there are multiple parties involved (such as one business paying on behalf of another business).  

More information on the numbers of applications for all sponsors can be found at: 

Additional data is provided for members in the graphs below, including the status of applications in lodgement (as at 24 May 2024); and deidentified information  

relating to CM MRA and CV application numbers, categories and outcomes by financial year from 2020. 

MQB Status of applications in lodgement (as at 24 May 2024) 

MRA vs CV application numbers (2021-2024) 

MRA vs CV application outcomes (2021-2024) 

Application Category (2021-2024) 

Number of RFIs sent by TGA to applicants (2021-2024) 

Number of incomplete CVs (2021-2024) 

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