Proposed new Therapeutic Goods Orders from Australia's TGA

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 recognize 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 July 1, 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.

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.

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 radio-labeled albumin will apply as standards but with BP/Ph Eur water for injection or human albumin substituted for the USP materials.