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

Version 1.0, June 2017

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3 July 2017

Notifications for prescription medicines (biological medicines)

Registered non-prescription medicines: This guidance came into effect on 1 July 2017.

Prescription medicines: This guidance is for information only and will come into effect on 1 January 2018.

This guidance outlines details of the kinds of variations to biological medicines that are considered as requests made under the provisions of section 9D(2C) 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.

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Drug product specification or test changes

Certified product details (CPD) documents

An updated CPD document is usually provided when a change is made to aspects of the drug product specifications, such as test requirements, limits of acceptance or non-pharmacopoeial test methods.

If any of the notification requests below result in changes to the product specifications or the non-pharmacopoeial test methods, please provide an updated and complete CPD document in PDF format using the CPD form available on the TGA website.

PSNL: Drug product specification—narrowing of test limits

Revision of the approved specifications for testing of the final drug product, to make the limits applied to test results more stringent.

  • The new limits must be either the same as, or more stringent than, any applicable standard or guidelines.

You must submit:

  • The revised set of specifications.

PSQC: Drug product specification—change to quality control testing equipment

Changes to equipment used for quality control testing of the final drug product (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing).

  • The change must meet any previously approved test method validity criteria.

You must submit:

  • A description of the new equipment.

You must generate the following data:

  • Appropriate validation data must have been generated for the changed equipment using the previously approved criteria and, where applicable, the same validation protocol as was used for the previously approved equipment.
  • If the type or brand of consumables used with the equipment is critical (that is, included in the protocol), appropriate validation data must also be generated for the relevant consumables.

Site of product manufacture changes

PMRS: Drug product site of manufacture - addition of new site of release-for-supply operations for a registered drug product

Addition of a new manufacturer for release for supply of the final drug product.

  • The new site must either have:
    • a current manufacturing licence issued by the TGA (Australian manufacturers) for this type of manufacture or
    • current GMP clearance issued by the TGA and valid at the time of this application (overseas manufacturers) for this type of manufacture.

You must submit:

  • Details of the new manufacturing site
  • The Australian licence and/or GMP clearance number.

Purification process changes

PPCR: Purification process—column life reduction

Reduction in the approved column life for columns used in the purification process.

You must submit:

  • A scientific justification for the column life reduction.

PPHR: Purification process—holding time reduction for a non-plasma-derived product

Reduction in the holding time for the drug substance, or intermediates created during manufacture of the drug substance, where the final drug product is non-plasma derived.

You must submit:

  • A scientific justification for the holding time reduction.

Fermentation changes

FPFM: Fermentation—change of filter manufacturer

Change to the manufacturer of a filter used in the fermentation process.

  • Do not change the internal process controls.
  • Do not use the filter for steps that require viral safety validation.
  • The new filter meets the same acceptance criteria as the previous filter.
  • The new internal process controls for the filtrate have not been changed.

You must submit:

  • The reason for the change.
  • The new manufacturer's details.

FPNC: Fermentation—more stringent internal process controls

Introduction of more stringent internal controls on the fermentation process.

  • Do not change the quality characteristics of the product.

You must submit:

  • The reason for the change.
  • Details of the new internal process controls.

FPRP: Fermentation—reduction in fermentation period

Reduction in the fermentation period, i.e. the time required to culture and harvest the cell line.

  • Reducing the fermentation period must not change the batch size.
  • Do not change the internal process controls.

You must submit:

  • The reason for the change.
  • Details of the change.

Plasma fractionation intermediates changes

PFCR: Plasma - changes to fractionation intermediates - column life reduction

Reduction in the approved column life for columns used in plasma fractionation.

You must submit:

  • Details of the change.
  • A justification for the proposed reduction.

PFSC: Plasma - changes to fractionation intermediates - more stringent internal process control

Introduction of more stringent internal controls on the plasma fractionation process.

  • Do not change the quality characteristics of the product.

You must submit:

  • Details of the change.
  • The reason for the change.

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