Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected

Version 2.0, December 2017

Book pagination

23 November 2017

Notifications for included biologicals

This guidance is subject to the finalisation of legislative amendments.

This guidance outlines the kinds of variations to included biologicals that are considered as requests made under the provisions of section 9D(3AC) of the Therapeutic Goods Act 1989 (known as 'notifications'). The conditions outlined below the description of each variation type must be met for the request to be processed as a notification.

Categories:

Changes as a result of amendments to an applicable standard

PT: Changes as a result of amendments to an applicable standard (e.g. pharmacopoeial or TGO)

For example, when changes to applicable standards or test methods are published (such as applicable Therapeutic Goods Orders, internationals standards or pharmacopeial tests), and are introduced into the manufacturing process.

  • Is not a change from the requirements of one pharmacopeia to another e.g. USP to BP; and
  • Any tests that were performed in addition to those of the standard must continue to be applied; and
  • Appropriate validation has been generated, where necessary; and
  • TGA has GMP-certified the manufacturing site for that step, where necessary.

You must submit:

  • Details of the change.

Biological starting material changes

DS: Changes to the donor selection criteria, including the medical and social history questionnaire

Increasing the stringency of donor selection criteria, resulting in rejection of previously acceptable donors, will not require pre-approval by the TGA.  Changes to the donor questionnaire that do not affect the information gathered (slight edits to questions, changes to question order etc.) can be introduced without pre-approval of the TGA.

  • More stringent donor selection criteria (previously acceptable donors would now be rejected); and
  • In conformity to TGO 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.

You must submit:

  • Details of the change.

TK: Changes to infectious disease test kits

When the infectious disease testing facility introduces new test kits for TGO 88-mandated infectious disease tests for donors.

  • No decrease in specificity, sensitivity, limit of detection and accuracy; and
  • Performed as per kit instructions, including the intended use; and
  • Same level of regulatory approval of the kit; and
  • TGA GMP certification of the testing facility.

You must submit:

  • Details of the change.

SM: Critical material change

This change will apply to critical materials used during the biological material collection manufacturing processes, but does not apply to materials that are biological starting materials, excipients or the primary container.

  • The critical parameters are equivalent or of greater quality [See note below] and
  • The containers are not made of a different composition (e.g. different polymer); and
  • The material is not an excipient; and
  • The material is not of human or animal origin.

You must submit:

  • Details of the change.

Note

Changes to some critical materials may have a more significant impact on the product than others and may require evaluation of the supporting data.

For example, a change to the quality of a growth supplement (critical material) can have a significant effect on the culture conditions and would often require re-validation of the manufacturing process; a change to a primary container (critical material) may require re-validation of product stability.

See ARGB Appendix 14: Glossary for more information on critical materials

Manufacturing process changes

MI: Changes to in-process specifications

Increasing the stringency of in-process or release specifications, resulting in rejection of previously acceptable product, will not require pre-approval by the TGA.

  • More stringent specifications; and
  • The change did not result from unexpected events identified during manufacture; and
  • The test procedure remains the same; and
  • Conforms to any applicable standard.

You must submit:

  • Details of the change.

BR: Removal of a product listed in the entry for a Class 2 biological

The deletion of one of the products that is part of an entry for a Class 2 biological.

You must submit:

  • Details of the change.

Manufacturing site changes

MA: Addition of a new site performing secondary packaging or secondary storage

The addition of new manufacturing sites restricted to product or biological starting material storage, or secondary (non-sterile) packaging steps.

  • TGA has GMP-certified the manufacturing site for that step.

You must submit:

  • Details of the change.

MT: Changes to site performing testing (including quality control and infectious disease testing)

For example, the addition of a new facility for testing: infectious diseases of donors; or microbial bioburden.

  • TGA has GMP-certified the manufacturing site for that step; and
  • There should be no impact on existing method validation; and
  • The test method has been adequately qualified to generate results comparable to that of the currently approved site(s) and
  • No modifications to the infectious disease testing algorithms used to determine fate of the product, if applicable and
  • A equivalent service agreement is in place with the test facility (TGO 88 10(7)).

You must submit:

  • Details of the change.

MR: Removal of a site of manufacturer

The deletion of a manufacturing site that is no longer used will require no specific conditions for pre-approval.

You must submit:

  • Details of the change.

Finished product control changes

BS: Changes to release specifications

Increasing the stringency of release specifications, resulting in rejection of previously acceptable product, will not require pre-approval by the TGA.

  • More stringent specifications; and
  • The change did not result from unexpected events identified during manufacture; and
  • The test procedure remains the same; and
  • Conforms to any applicable standard.

You must submit:

  • Details of the change.

BT: Reduction in shelf-life of finished product or shipping timeframes

The reduction in proposed product shelf life or acceptable shipping time frames will not require pre-approval by the TGA when the changes do not alter the currently used conditions (shipping configuration, product storage temperatures).

  • Revised specifications are still within the scope of the TGA approved validation studies; and
  • No quality or safety concerns triggered the change.

You must submit:

  • Details of the change.

Labelling changes

LC: Changes to the product labels or supporting documents (e.g. product information, consumer medicine information and patient card)

A limited scope of changes to product labelling is permissible without pre-approval.

  • The change must be one of the following:
    • Changing the name, address or other details of the sponsor, manufacturer or distributor; or
    • Change to name of active ingredients as a result of changes to the Australian approved name.

You must submit:

  • Details of the change.

Book pagination