British Pharmacopoeia 2007 - impact on Listed medicines
Chondroitin sulfate shark and bovine (sodium) and R,S-alpha-lipoic acid are now the subject of British Pharmacopoeia Monographs.
On 30 May 2007, the National Manager of the TGA specified that from 1 July 2007 the British Pharmacopoeia (BP) 2007 <http://www.tga.gov.au/legis/frli/bp2007.htm> would be the default material standard used by the TGA.
As a result of the adoption of the BP 2007, chondroitin sulfate shark and bovine (sodium) and R,S-alpha-lipoic acid are now the subjects of BP monographs. Therefore, the compositional guidelines have been removed from the TGA website and compliance with the BP is mandatory unless an exemption is held.
Sponsors attempting to justify non-compliance with prescribed standards (for example, the BP) should apply to the TGA in writing, seeking an exemption under Section 14 of the Therapeutic Goods Act 1989 (the Act). Section 14 Exemption requests should explain why the standard(s) cannot be met and detail what alternative(s) are proposed and why. The delegate of the Secretary will review the request and sponsors will be advised in writing of the delegate's decision.
The relevant BP2007 monographs are: Chondroitin Sulphate Sodium and Thioctic acid. Sponsors should note that the current Australian Biological Names and Australian Approved Names for these substances still apply. Sponsors should not attempt to change their labelling or ARTG entries to match the BP2007 names.
In relation to Chondroitin sulfate, sponsors should note that although the quality standard has been broadened in the BP2007 (to include chondroitin sulfate of terrestrial or marine origins), the substances approved for use in Listed medicines have not been broadened. At present, only shark- and bovine-derived chondroitin sulfate can be used in Listed medicines.
Consultation
Stakeholder consultation on this amendment to the definition of British Pharmacopoeia contained in the Act involved an open invitation for comment on the TGA's website and targeted letters to industry associations.
Responses received indicated support for amendment of the definition of British Pharmacopoeia contained in the Therapeutic Goods Act 1989.