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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

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GMP clearance basics

What GMP clearance is

GMP Clearance is a non-statutory mechanism used to verify that overseas manufacturing sites comply with the principles of GMP for the products being supplied to Australia. It was introduced as a way to reduce the regulatory burden on industry while maintaining assurance that the suitability of manufacturing processes and quality control procedures are appropriate.

The TGA may issue GMP clearance to sponsors of a medicine or API that is manufactured overseas if there is acceptable evidence demonstrating that the overseas manufacturer complies with the principles of GMP (the manufacturing principles or equivalent international standards).

Why GMP clearance is required

Sponsors are required to obtain GMP clearance for overseas manufacturers of their registered or listed products to satisfy sections 25(1) (g), 26(1) (g) and 26A (3) of the Therapeutic Goods Act 1989. This upholds the main objective of the Act, which is to ensure the safety, quality, efficacy and timely supply of therapeutic goods for Australian consumers.

What manufacturing steps require GMP clearance

All steps of manufacture are required to be GMP compliant unless they are exempt. However, GMP clearance is not necessarily required unless the product is to be registered or listed and the manufacturing step recorded on the Australian Register of Therapeutic Goods (ARTG).

Guidance is available regarding the different types of medicines and their requirements including:

Ensure that the manufacturing steps you select are supported by the evidence to be provided with the application and that they align with the details required for product registration or listing.

If you are unsure whether you require GMP clearance for the purpose of registering or listing your product, contact the relevant product regulatory area prior to submitting a GMP clearance application.

If the selections you made result in validation issues with the regulatory submission system, you may be required to submit a variation application and pay the relevant fees.

How GMP clearance is obtained

GMP clearance can be obtained per manufacturing site 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

This guidance deals with obtaining GMP clearance through the MRA or CV desk top assessment pathways only. The Australian manufacturing licences and overseas GMP certification guidance provides more information for those obtaining a GMP clearance following a successful TGA on-site inspection.

Letters of Access (LoA) are not a pathway to obtain GMP clearance but rather a type of evidence that can be provided when using either the MRA or CV pathways. LoA are explained further in step 3.

How much GMP clearance costs

You are required to pay the relevant GMP clearance fees to have your application assessed, as we are required to recover the full cost of our regulatory activities.

Separate applications are required to be submitted for API and finished products, even if the evidence is applicable to both.

Similarly, separate applications are required for each unique site address in the TGA database irrespective of whether they are using the same evidence.

Fees for GMP clearance can include:

  • GMP clearance application processing fee: applies to all GMP clearance applications except extensions and administrative variations
  • obtaining evidence from an overseas regulatory authority (liaison): applies to all requests to obtain evidence (GMP certificates) for MRA applications and all CV applications that use US Food and Drug Administration (US FDA) evidence
  • Compliance Verification (in lieu of an overseas GMP inspection): applies to all GMP clearance applications using the CV pathway unless otherwise stated in the table below
  • reinstatement of an expired GMP clearance: applies to applications to reinstate expired GMP clearances
Application type Evidence provided Application Processing fee Obtaining evidence fee Compliance verification fee
MRA MRA documentation Applicable Where requested by applicant or required Not applicable
LoA to Evidence
LoA to Clearance
CV Sterile/Non-Sterile API CV documentation Applicable Where requested by applicant or required Applicable
LoA to Evidence
LoA to Clearance Applicable Not applicable Not applicable
CV Sterile/Non-Sterile finished product CV documentation Applicable Where requested by applicant or required Applicable
LoA to Evidence
LoA to Clearance Applicable Not applicable Applicable
CV Contract testing laboratory or steriliser CV documentation Applicable Where requested by applicant or required Applicable
LoA to Evidence
LoA to Clearance Applicable Not applicable Applicable
TGA Certificate TGA Certificate Applicable Not applicable Not applicable
LoA to Evidence
LoA to Clearance
Applicable= Applicable Not applicable= Not Applicable Where requested by applicant or required= Where requested by applicant or required

The following application types do not incur a fee:

  • extensions
  • administrative changes
  • decrease in scope
  • cancellation

How long GMP clearance takes

We provide target processing timelines for GMP clearance applications where possible to assist industry in planning their regulatory activities. However, target processing timelines are dependent on several factors such as the:

  • volume of applications received
  • available TGA resources
  • priority of other applications, for example, applications related to new registrations or listings and variations to existing registrations or listings.

For the MRA pathway, the current target processing timeline is 30 working days.

For the CV pathway, the target processing timelines are also dependent on the:

  • quality and completeness of the application
  • complexity and/or risk of the manufacturing steps or products
  • time taken for a sponsor to respond to requests for further information or clarification.

We do not consider processing times to begin until all fees have been paid and all evidence has been received. This may be several weeks after submitting your GMP clearance application.

Sponsors of therapeutic goods in Australia play an important role in ensuring the safety, quality, efficacy and timely supply of therapeutic goods for Australian consumers. As a sponsor, you have responsibilities to maintain GMP clearance for all overseas manufacturing sites used in the manufacture of your registered or listed medicine at all times.

If you do not meet your responsibilities detailed on the sponsor responsibilities web page:

  • you may not be issued a GMP clearance
  • you may forfeit any fees you have paid
  • if you have an active GMP clearance, it may be cancelled.

The GMP clearance process

This step-by-step guide assists sponsors when applying for a new GMP clearance while also covering the steps for maintaining an existing active GMP clearance.

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