オーストラリアTGA／Complementary Medicinesの規制フレームワークに関するプレゼン資料

11/10付でオーストラリアTGAから「TGA presentation: Complementary Medicines Regulatory (CMA) Annual Conference, 26 October 2017」と題して、“Complementary Medicines”に関するプレゼン資料が公開されています。
 
サプタイトルに「Update on Reforms to the Regulatory Framework for Complementary Medicines 」とあるので、“Complementary Medicines”の規制フレームワーク改正に基づく内容と思われます。
 
ちなみに、“Complementary Medicines”というジャンル、本邦では馴染みがありませんが、TGAの定義によれば以下の通りです。
 
Therapeutic goods consisting wholly or principally of one or more designated active ingredients, each or which has a clearly established identity and
　a. a traditional use OR
　b. any other use prescribed in the regulations
 
Schedule 14 of the Therapeutic Goods Regulations 1990 defines the following as 'designated active ingredients':
　1. an amino acid
　2. charcoal
　3. a choline salt
　4. an essential oil
　5. plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
　6. a homoeopathic preparation
　7. a microorganism, whole or extracted, except a vaccine
　8. a mineral including a mineral salt and a naturally occurring mineral
　9. a mucopolysaccharide
　10. non-human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
　11. a lipid, including an essential fatty acid or phospholipid
　12. a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis
　13. a sugar, polysaccharide or carbohydrate
　14. a vitamin or provitamin
 
本邦において、これら品目に関係する企業がどれだけあるのか存じませんが、ご参考まで。
 
関係者及び興味のある方は、下記URLのウェブサイト並びにサイト内の資料をご参照ください。
https://www.tga.gov.au/tga-presentation-complementary-medicines-regulatory-cma-annual-conference-26-october-2017