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GMP clearance process - compliance verification

11 September 2017

The number of GMP clearance applications submitted to the TGA has increased significantly in the last number of years, from approximately 4000 in 2014/2015 to more than 6000 in 2016/2017. We anticipate this high volume of applications to continue and possibly increase.

We estimate that more than 60% of Compliance Verification (CV) GMP clearance applications we receive do not provide all required supporting evidence to demonstrate that the manufacturing site is acceptable for the supply of therapeutic goods  to the Australian market. Where applications have been incomplete, we have made efforts to contact the applicants and request the required supporting evidence, and often this process involves several attempts on our behalf for each application before appropriate evidence is received.

To ensure that applicants who do provide all required information with their application are not disadvantaged, and to reduce our processing timelines, we are implementing a number of process improvements.

Make sure your application is complete

The GMP clearance guidance specifies that Australian sponsors of medicines manufactured overseas have a responsibility to ensure that all required documents are submitted with a GMP Clearance application. Failure to do so may result in the clearance not being issued.

Application Receipt

For CV applications submitted before 26 September 2017, we will provide applicants with one opportunity to submit any outstanding supporting evidence during the application receipt stage, i.e. before it is progressed to assessment. We will specify a due date. After this due date, irrespective of whether the requested information has been received, we will progress the application to assessment.

For CV applications submitted on or after 26 September 2017, once payment of all outstanding fees has been received, we will progress the application to assessment.

We will not conduct an assessment of the information you submit in support of your application during the application receipt stage.

To assist applicants preparing applications we will be publishing a revised GMP clearance guidance document and a new web-based GMP Clearance Application Assistance Tool (CAAT) shortly. In parallel we will also be implementing the re-designed application forms for GMP clearance. Prior to submitting your GMP clearance application we strongly encourage you to refer to the GMP clearance guidance and CAAT to determine the evidence required to support your application.

Application assessment

All applications that have passed the receipt process will be assessed. During assessment we will make a determination, taking into account the information and evidence provided with the application.

Where deficiencies are identified and/or further clarification is required, we will provide you with a written confirmation of deficiencies identified, and a due date by which to provide a complete response.

After this due date, we will make a determination on your application, regardless whether we have received a response from you. The determination will be made based on the information available.

It is therefore important that you familiarise yourself with the information requirements specified in the GMP clearance guidance.

Make sure the scope of your application is accurate

When preparing GMP clearance applications, it is the responsibility of the sponsor to select a  scope that accurately reflects the dosage forms and/or manufacturing steps performed by the overseas manufacturer. You should take specific care to ensure that your selected scope is fully supported by the evidence provided.

From 26 September 2017 GMP Clearances will be issued for the scope that is supported by the evidence provided and you may not be contacted prior to finalising the application.

Typical examples of how we will manage incorrect application scopes include (but are not limited to):

  • Finished product dosage forms – If the dosage form selected in the application is a group term which contains several other dosage forms that are not supported by the supplied evidence, the scope will be changed to the dosage forms specifically supported by the evidence.
  • Finished product steps of manufacture - If the manufacturing step selected in the application is a group term which contains several steps of manufacture that are not supported by the evidence, the scope will be changed to the manufacturing steps that are specifically supported by the evidence.
  • Active Pharmaceutical Ingredient Applications – If the manufacturing step selected in the application is 'active material manufacture', but the evidence shows that this site does not perform microbiological testing the manufacturing step will be changed to 'active material manufacture excluding microbiological testing'.
  • When a nonsensical scope is included in the application, for example, 'non-sterile injection dosage forms', we will change this accordingly, e.g. to 'sterile injection dosage forms'.

Please note:We strongly recommend that prior to submitting your GMP clearance application, you refer to the current GMP clearance guidance and to the TGA code tables available on the TGA eBS webpage for the correct dosage forms and manufacturing steps.