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Proposed new Therapeutic Goods Orders

Consultation

22 September 2009

Standard for human albumin, Standard for water for injection for parenteral medicines and Order under section 3C(1) of the Act

Documents

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Written submissions are invited on the following documents:

Background

The Australian Government is implementing a reform agenda to update and streamline the regulatory framework for therapeutic goods in Australia. One of these changes has been to recognise the European Pharmacopoeia (Ph Eur) and the United States Pharmacopeia-National Formulary (USP), in addition to the British Pharmacopoeia (BP), as standards for medicines and other therapeutic goods that are not medical devices. The Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 provided for this change, which came into effect on 1 July 2009.

The Therapeutic Goods Committee (TGC) is the committee with the responsibility to advise the Minister for Health and Ageing on the adoption of standards and matters relating to standards. The TGC has considered the suitability of certain monographs of the USP for vaccines, blood products, water for injection and some other substances, and whether these monographs are appropriate to be 'standards' under the Act. The TGC has published its considerations.

For the reasons identified in Summary of USP monographs affected, the TGC proposed that Orders should be developed to specify that the 'standard' for the nominated vaccines, blood products, water for injection and other substances should be the BP or the Ph Eur, and not the USP. The TGC recommended that interested parties should be consulted on these proposals.

It is proposed that an Order under the new Section 3C of the Act be made to specify monographs of the USP that are not accepted as 'standards'. Section 3C has the effect of narrowing the definition of the USP such that the monographs named in the Section 3C Order are deleted from the Act's definition of the USP. Consequently, individual or general monographs of the BP or Ph Eur would apply as 'standards' to the therapeutic goods named in the Section 3C Order.

Please note that inclusion of a monograph in the Section 3C Order does not imply that such a product is available for supply in Australia.

It is also proposed that Orders under Section 10 of the Act be made to specify that Water for Injection for use in parenteral medicines, and Albumin from human sources, must comply with the monographs of the BP or Ph Eur. By relying on the application of Section 13(2) of the Act, monographs in the USP that use Water for Injection or Human Albumin as starting materials will be retained as 'default standards'. In effect, USP monographs for an injectable medicine or a radiolabelled albumin will apply as standards but with BP / Ph Eur Water for Injection or Human Albumin substituted for the USP materials.

Enquiries

Enquiries should be directed via email to standards@tga.gov.au or by telephone to 02 6232 8623.

What will happen to submissions?

Submissions will be provided to the Therapeutic Goods Committee for consideration.

Recommendations made by the TGC following consideration of submissions from interested parties will be published on the TGA website as committee outcomes.

Notes on submissions

All submissions received will be placed on the TGA's website, unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Attachment: Summary of USP monographs affected by the proposed new Therapeutic Goods Orders Standard for human albumin, Standard for water for injection for parenteral medicines and Order under section 3C(1) of the Act

USP monographs affected by the Section 10 Order regarding albumin
USP monographs affected by the Section 10 Order regarding albumin Reasons
Albumin Human

Reliance on FDA decisions, via chapter <1041> Biologics

lack of Nucleic Acid Amplification Technology (NAT) testing for starting plasma

inadequate product characterisation lack of testing for B19 virus

All USP monographs that contain human albumin
USP monographs affected by the Section 10 Order regarding water for injection
USP monographs affected by the Section 10 Order regarding water for injection Reasons
Water for Injection

Allowance for manufacture of water by reverse osmosis and methods other than distillation

Lack of requirement for monitoring of total viable aerobic count prior to sterilisation

Bacteriostatic Water for Injection
Sterile Water for Injection
All USP monographs for parenteral medicines that contain Water for Injection
USP monograph to be exempted from being a 'standard' via the Section 3C Order
USP monograph to be exempted from being a 'standard' via the Section 3C Order Reasons
Anthrax Vaccine Adsorbed

One or more of:

reliance on FDA decisions, via chapter <1041> Biologics

reference to revoked sections in the US Code of Federal Regulations

lack of thermal stability test requirement

potency test and units not comparable to those established in use in Australia

BCG Vaccine
Influenza Virus Vaccine
Measles Virus Vaccine Live
Measles, Mumps and Rubella Virus Vaccine Live
Measles and Rubella Virus Vaccines Live
Mumps Virus Vaccine Live
Poliovirus Vaccine Inactivated
Rabies Vaccine
Rubella Virus Vaccine Live
Smallpox Vaccine
Yellow Fever Vaccine
Diphtheria and Tetanus Toxoids Adsorbed
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use
Tetanus Toxoid Adsorbed
Tetanus Toxoid
Tuberculin
Pancrelipase Potency test and units not comparable to those established in use in Australia
Pancreatin
Rho (D) Immune Globulin

One or more of:

reliance on FDA decisions, via chapter <1041> Biologics

lack of Nucleic Acid Amplification Technology (NAT) testing for starting plasma

inadequate product characterisation

lack of testing for B19 virus

potency test and units not comparable to those established in use in Australia

Antithrombin III Human
Antihemophilic Factor
Cryoprecipitated Antihemophilic Factor
Factor IX Complex
Hepatitis B Immune Globulin
Immune Globulin
Plasma Protein Fraction
Rabies Immune Globulin
Tetanus Immune Globulin
Varicella-Zoster Immune Globulin