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Important Ingredient / Substance Updates

31 Oct 2019 8:30 AM | Anonymous

Please see the linked technical alert below for important details, developments, and targeted discussions on important raw material and listed medicine ingredients updates:

1) CMA Version 4 Release of Allergens/Substances questionnaire: We are pleased to release a new Version 4 of the "Allergens and other Substances of Concern" raw material questionnaire for industry, with a number of improvements.

2) New Substance CMA working group: CMA are convening a new specific working group for members who are closely involved in NEW SUBSTANCE applications, including raw material supplies, sponsors, and consultants to discuss current policy issues, developments and options.

3) Comparable Overseas (Assessment) Bodies: A preview of the Comparable Overseas (Assessment) Bodies or "COBs" is now available through CMA, including the updated draft guidelines. The drafted list includes bodies such as FSANZ, EFSA, FDA, Health Canada, and more.

4) Proprietary Ingredients: Feedback from TGA/industry and a reminder for all suppliers and sponsors using PIs listed with the TGA.

5) Other updates, including a TGA flagged issue regarding the way the Permissible Ingredients Determination is made and used.

We would also like to advise the TGA have announced that Kaylene Raynes will be replacing Michael Shum as the Director of Business Improvement and Support Section of the Complementary & OTC Medicines Branch, a role that encompasses the remaining complementary medicine regulatory reforms. Michael will be entering the Prescription Medicines Branch.

Technical Alert link: RAW MATERIAL & LISTED MEDICINE INGREDIENT UPDATES

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