The Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 amended the Therapeutic Goods Act 1989 (the Act) in relation to standards applying to medicines and other therapeutic goods that are not medical devices.

The purpose of the amendments is to recognise the European Pharmacopoeia (Ph Eur) and United States Pharmacopeia-National Formulary (USP) as standards additional to the British Pharmacopoeia (BP).

The changes mainly affect section 3 (Interpretation) and sections 10-13 (Standards) of the Act.

On 1 July 2009 the Act was amended to recognise the European Pharmacopoeia (Ph Eur) and United States Pharmacopeia-National Formulary (USP) as standards additional to the British Pharmacopoeia (BP).

Information on other amendments to the Act with their different dates of effect is available at Regulatory reform <http://www.tga.gov.au/regreform/index.htm>.

The inclusion of the Ph Eur, the USP and the BP as alternative standards was proposed in the draft Medicines Rule for the joint Australia New Zealand therapeutic products regulatory scheme in 2006.

In mid 2008 the TGA completed stakeholder consultations on a number of regulatory reforms proposed for each therapeutic product sector, some of which flowed from the work undertaken for the joint regulatory scheme. Industry was provided with the opportunity for discussion of how these reforms would be implemented in the Australian context.

Since the commencement of the Act in 1991, the British Pharmacopoeia has been the standard applying under the Act, in the absence of a standard determined by the Minister under section 10 of the Act (that is, a Therapeutic Goods Order). The BP was informally referred to as the default standard.

From 1 July 2009, the definition of "default standard" has been included in section 3 of the Act. "Default standard" means any of the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopoeia-National Formulary.

From 1 January 2010, the definition of the BP has been BP 2010.

The definition of the BP under the Act includes the BP 2010 Online updates in January, April and July 2010. These updates will consist of the supplements to the European Pharmacopoeia that become effective at those times. While the BP 2010 Online now gives the choice of the "as published" or "updated" versions, it is the "updated" version that is defined by the Act.

From 1 July 2009, the definition of the European Pharmacopoeia (Ph Eur) has been included in section 3 of the Act.

The English edition of the Ph Eur that came into force under the Act on 1 July 2009 was the 6th edition, as amended by the non-cumulative supplements 6.1 to 6.5 inclusive.

Thereafter, 'European Pharmacopoeia' means any additions, amendments and new editions from the effective date published by the Council of Europe or any replacement body.

From 1 July 2009, the definition of the United States Pharmacopeia-National Formulary (USP) has been included in section 3 of the Act.

The English edition of the USP that came into force under the Act on 1 July 2009 was the 32nd edition.

Thereafter, 'United States Pharmacopeia-National Formulary' means any additions, amendments and new editions from the effective date published by the United States Pharmacopeial Convention or any replacement body.

The Accelerated Revision process used by the United States Pharmacopeial Convention includes Revision Bulletins, Interim Revision Announcements, and Errata published in the Pharmacopeial Forum and on the USP website that come into effect on the dates published.

Information on the pharmacopoeias, including purchase, can be obtained from:

• British Pharmacopoeia 2010 information
  <http://www.pharmacopoeia.co.uk/2010/about.htm>
• European Pharmacopoeia 6th edition information
  <http://www.edqm.eu/site/The_European_Pharmacopoeia_6th_Edition-681.html>
• USP 32 - NF 27 information
  <http://www.usp.org/products/USPNF>

The easiest way to determine what edition of each pharmacopoeia is current, and the publication plans for future editions, is to refer to the Internet sites of the pharmacopoeias.

The BP is published annually around August and takes effect on the following 1 January. The BP 2009 became the edition in force in Australia on 1 June 2009 (via the definition published by the Delegate of the Minister for Health and Ageing in the Federal Register of Legislative Instruments) and was the edition in force on 1 July 2009.

The edition of the Ph Eur that came into force on 1 July 2009 is the 6th edition, as amended by the non-cumulative supplements 6.1 to 6.5 inclusive. Supplement 6.6 will come into effect on 1 January 2010. Supplements to the Ph Eur are published six months prior to coming into effect; corrections become effective at publication. In exceptional cases, monographs are introduced between supplements via publication in the PharmEuropa <http://www.edqm.eu/en/Pharmeuropa_Pharmeuropa_Bio_Scientific_Notes-584.html>.

The edition of the USP that came into force on 1 July 2009 is the 32nd edition of the USP. The non-cumulative First Supplements came into effect on 1 August and the non-cumulative Second Supplement will come into effect on 1 December 2009. Occasionally, the implementation dates for individual monographs or chapters are deferred. Changes to the USP can also become official between supplements by publication as Interim Revision Announcements in the Pharmacopeial Forum <http://www.usp.org/USPNF/pf>. In exceptional cases, revisions to the USP take effect upon publication.

The following tabulation is based on information current at 27 January 2010:

Note: The United States Pharmacopeial Convention has recalled USP 33-NF 28. The previously published dates of 1 May 2010 for USP 33-NF 28 to become effective, and 1 August 2010 for the First Supplement to USP33-NF28 to become effective, are no longer correct. The current edition, USP 32-NF 27, will remain official until further notice. Further information is available from the USP–NF <http://www.usp.org/USPNF/recall.html> website.

The preliminary pages of each edition or supplement highlight the changes introduced in that publication. See:

• the European Pharmacopoeia's Contents to be added in Supplement 6.5 (pdf,60kb) <http://www.edqm.eu/medias/fichiers/List_of_Contents_Supplement_65_English.pdf>, Contents to be added in Supplement 6.6 (pdf,57kb) <http://www.edqm.eu/medias/fichiers/List_of_Contents_Supple1.pdf> and Contents to be added in Supplement 6.7 (pdf,63kb) <http://www.edqm.eu/medias/fichiers/List_of_Contents_Supplement_67_English.pdf>
  Contents to be added in Supplement 6.8 (pdf,436kb) <http://www.edqm.eu/medias/fichiers/List_of_Contents_Supplement_68_English.pdf>
  This information about the changes to be introduced in the European Pharmacopoeia supplements is also relevant to the BP 2010 Online updates.
• the United States Pharmacopoeia's New Official Text <http://www.usp.org/USPNF/newOfficialText/>.
• About BP 2010 <http://www.pharmacopoeia.co.uk/>.

No. Since 1 July 2009, subsection 13(2) of the Act provides that if a standard determined by the Minister under section 10 of the Act and a "default standard" both apply to therapeutic goods and are inconsistent, the section 10 standard prevails to the extent of the inconsistency.

Therapeutic Goods Order No.70B Standards for export only medicine <http://www.tga.gov.au/docs/html/tgo/tgo70b.htm> (a standard determined by the Minister under section 10 of the Act) specifies the editions of the Ph Eur and USP that apply as standards for export only medicines.

No. Since 1 July 2009, subsection 13 (2) of the Act provides that if a standard determined by the Minister under section 10 of the Act and a "default standard" both apply to therapeutic goods and are inconsistent, the section 10 standard prevails to the extent of the inconsistency.

Therapeutic Goods Order No. 69 General requirements for labels for medicines <http://www.tga.gov.au/docs/html/tgo/tgo69.htm> (a standard determined by the Minister under section 10 of the Act) specifies the matters that must be included on the labelling of a modified release tablet.

No. Since 1 July 2009, subsection 13 (2) of the Act provides that if a standard determined by the Minister under section 10 of the Act and a "default standard" both apply to therapeutic goods and are inconsistent, the section 10 standard prevails to the extent of the inconsistency.

Therapeutic Goods Order No. 78 Standard for tablets and capsules <http://www.tga.gov.au/legis/tgo/tgo78.htm> (a standard determined by the Minister under section 10 of the Act) specifies the circumstances under which dissolution testing is required for listed tablets.

No. Since 1 July 2009, subsection 13 (2) of the Act provides that if a standard determined by the Minister under section 10 of the Act and a "default standard" both apply to therapeutic goods and are inconsistent, the section 10 standard prevails to the extent of the inconsistency.

Therapeutic Goods Order No. 77 Microbiological standards for medicines <http://www.tga.gov.au/legis/tgo/tgo77.htm> (a standard determined by the Minister under section 10 of the Act) specifies the relevant acceptance criteria for microbiological quality for a medicine.

Applications to the TGA are required to name ingredients using Australian Approved Names. Further, Therapeutic Goods Order No. 69 General requirements for labels for medicines <http://www.tga.gov.au/docs/html/tgo/tgo69.htm> requires that labels show the names of ingredients as the names approved for inclusion in the Australian Approved Names List.

There are substances with Australian Approved Names that differ from the names used in the BP and the USP. The onus is on the sponsor to consider synonyms in the default standards before proceeding to develop an in-house specification for an ingredient.

The current list of Australian Approved Names is available at Australian Register - Ingredients.

Sponsors will be familiar with the need to consider any impact on ingredient and product specifications of new or amended monographs appearing in each update of the BP. The same requirement will now apply to all three "default standards".

Where compliance with a BP general monograph was the basis of product approval, sponsors will need to identify and comply with a relevant individual monograph in the USP. Sponsors have the 12 month transition period to address this situation for products that were included in the ARTG prior to 1 July 2009. The usual procedures for changing product standards and specifications apply; see Australian regulatory guidelines for prescription medicines (ARGPM) <http://www.tga.gov.au/pmeds/argpm.htm> and the Australian regulatory guidelines for OTC medicines (ARGOM) <http://www.tga.gov.au/docs/html/argom.htm> and the Australian regulatory guidelines for complementary medicines (ARGCM) <http://www.tga.gov.au/docs/html/argcm.htm>.

The USP monograph will apply as a standard to products that are listed after 1 July 2009.

For products that were included in the ARTG prior to 1 July 2009, sponsors can use the draft compositional guideline or other in-house specification for up to 12 months; after the 12 month transition period, the USP monograph will apply as a standard.

An exemption from the requirements of the Act can be granted by the Secretary of the Department of Health and Ageing in accordance with sections 14 or 14A of the Act. These sections of the Act relate to approvals for the supply, importation or export of a medicine that does not conform to an applicable standard, such as the "default standards". Such approvals may be granted unconditionally or subject to conditions, and can relate to one batch or all batches of a medicine.

Where exemption from the "default standards" is sought, the sponsor should apply in writing to the TGA, stating precisely the aspects of the "default standards" against which the exemption is sought and providing justification for the exemption sought. When an exemption is granted, information concerning the exemption is published in the Commonwealth Government Notices Gazette.

The exemption would be with respect of compliance with the BP, Ph Eur and USP. (If the product complied with one of these pharmacopoeias, an exemption would be unnecessary).