Naming and regulatory approach for amino acids chelates, chelates and organic acid salts
Consultation
23 March 2007
This consultation closed on 31 March 2007.
The TGA sought input to assist in the development of Compositional Monographs for chelated and organic acid salt ingredients for use in low risk medicines under the proposed Australia New Zealand Therapeutic Products regulatory scheme.
The TGA sought submissions from interested parties in order to gain a better understanding of ingredients, collectively called "chelates", used in Listed medicines. The TGA will use information provided in submissions to facilitate the development of appropriate, safety- and quality-based Compositional Monographs to assist the regulation of these ingredients under the proposed joint Australia New Zealand Therapeutic Products regulatory scheme. Therefore, this was an opportunity for stakeholders to have input in providing greater guidance on these types of ingredients and the Office of Complementary Medicines (OCM) encourages all interested stakeholders to provide a submission.
The OCM recently wrote to sponsors, whose medicines state they contain metal chelates, amino acid chelates or organic acid salts, seeking assistance in developing Compositional Monographs that define the quality of these substances. A copy of the letter sent to sponsors is contained below detailing the information sought.