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Adoption of British Pharmacopoeia 2008 (BP 2008)

Consultation

29 January 2008

This document was released in December 2007 for comment and closed on 29 January 2008. It remains on this website as a historical reference.

Background

The British Pharmacopoeia currently is the principal (or default) standard applying under the Therapeutic Goods Act 1989 (the Act) to medicines and other therapeutic goods that are not medical devices.

The British Pharmacopoeia is defined in the Act as follows:

British Pharmacopoeia means the edition of the book of that name, including any additions or amendments, that was in effect for the purposes of the Therapeutic Goods Act 1966 immediately before the commencement of this section and, if additions or amendments of that book are made after that commencement, or new editions of that book are published after that commencement, includes those additions or amendments, or those new editions, from a day specified by the Minister by order published in the Gazette.

In recent years, new editions of the BP have been adopted in Australia on a date as close as practical to the date on which the publication becomes effective in the United Kingdom (UK). This helps to maintain consistency with international standards for the quality and safety of therapeutic goods and allows for the timely update of technical matters such as analytical methods. Since 1 July 2007, British Pharmacopoeia 2007 (BP 2007) has had effect in Australia.

With the postponement of the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA), the BP will remain the default pharmacopoeia for Australia for the immediate future.

Proposal

The British Pharmacopoeia 2008 (BP 2008) was published in August 2007 and will enter into force in the United Kingdom on 1 January 2008.

The TGA proposes that BP 2008 also be adopted in Australia, on a date yet to be determined, and therefore seeks comment from stakeholders on the adoption of the BP 2008 as the edition of that standard defined under the Act.

Comment sought

The TGA sought comment on any particular difficulties for sponsors that may be associated with the adoption of BP 2008.

The TGA also sought information to allow preliminary assessment of the regulatory impact of this proposal, as required under Government best practice regulation policy. Specifically information is sought on business compliance costs and impacts on business and individuals, including restrictions on competition, which would be associated with adoption of BP 2008.

It was also requested that responses provide comment on the costs and other consequences of NOT amending the definition of British Pharmacopoeia from BP 2007 to BP 2008. Relevant matters may include the acceptability of Australian products in overseas markets; the potential for the import of products manufactured to superseded standards; and consequences for the sourcing of materials and international harmonisation.

Comments from stakeholders will be referred to the Therapeutic Goods Committee (the expert committee established under regulation 34 of the Therapeutic Goods Regulations 1990 to advise the Minister on matters relating to standards for therapeutic goods), which will then make a recommendation to the Minister concerning the adoption and its timing.

Stakeholders should note that, notwithstanding the intention under ANZTPA to broaden the meaning of default pharmacopoeia, current therapeutic goods legislation does not permit the option of multiple default pharmacopoeias.

Technical information

As well as monographs of British origin, BP 2008 contains all monographs of the 5th edition of the European Pharmacopoeia (Ph. Eur), as amended by Supplements 5.1 - 5.8 inclusive. In contrast, BP 2007 contained all monographs of the 5th edition of the Ph. Eur as amended by Supplements 5.1 - 5.5 inclusive only.

The Introduction to BP 2008 lists additions, omissions and technical changes to monographs included in this new edition. Amendments to monographs of the Ph. Eur, although not separately identified in the Introduction to the BP 2008, are described in Pharmeuropa, the journal published quarterly by the European Pharmacopoeia Commission. Information on the revised or corrected texts published in Supplements 5.6 - 5.8 to the 5th edition of the Ph. Eur can be obtained through the Pharmeuropa link on the European Directorate for the Quality of Medicines & Healthcare website.