Kampo

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on: 
Sunday, March 10, 2024

1

Key Points: 
    • 1
      Committee on Herbal Medicinal Products (HMPC)

      Questions & Answers on the European Union framework
      for (traditional) herbal medicinal products, including those
      from a ?non-European? tradition

      Table of Content
      1.

    • European Pharmacopoeia

      SAWP

      Scientific Advice Working Party

      SmPC

      Summary of Product Characteristics

      THMP

      Traditional Herbal Medicinal Product

      TUR

      Traditional Use Registration

      WEU

      Well-Established Use

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Terminology of herbal medicinal products (Q&A 1-4)

      Question 1
      What are herbal substances, herbal preparations, and herbal medicinal products?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 4
      Are food supplements regulated under the European Union (EU) pharmaceutical legislation
      for (traditional) herbal medicinal products ((T)HMPs)?
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Regulation of herbal medicinal products in the European Union (Q&A 511)

      Question 5
      Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
      products (HMPs), including traditional herbal medicinal products (THMPs), in the European
      Union (EU)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • These countries have,
      through the EEA agreement, adopted the complete Union acquis on medicinal products and are
      consequently parties to the Union procedures.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Specific provisions for traditional herbal medicinal products (Q&A 1221)

      Question 12
      Which indications can be granted for traditional herbal medicinal products (THMPs)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Nov. 2023
      Answer 17

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 29
      Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
      (registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
    • Discussion with Member States intended to be

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

Alps Pharmaceutical confirms through human pharmacokinetic studies that its newly developed natural quercetin formulation can significantly reduce quercetin usage

Retrieved on: 
Monday, August 1, 2022

Co., Ltd. (Hida, Japan, President: Osamu Ushimaru) announced that it has confirmed through human pharmacokinetic studies of its new quercetin formulation, EubioQuercetin, that the amount of quercetin used can be reduced to one quarter of the original amount.

Key Points: 
  • Co., Ltd. (Hida, Japan, President: Osamu Ushimaru) announced that it has confirmed through human pharmacokinetic studies of its new quercetin formulation, EubioQuercetin, that the amount of quercetin used can be reduced to one quarter of the original amount.
  • Health occupies a central position in the SDG 3, and quercetin is a supplement that plays a significant role in achieving this global goal.
  • To accomplish this, Alps Pharmaceutical has spent many years researching natural quercetin and has finally succeeded in developing EubioQuercetin, a new quercetin formulation made from only safe and natural food ingredients.
  • "Natural quercetin, found in fruits and vegetables, is fully absorbed by the body and contributes to good health.

Alps Pharmaceutical confirms through human pharmacokinetic studies that its newly developed natural quercetin formulation can significantly reduce quercetin usage

Retrieved on: 
Monday, August 1, 2022

Co., Ltd. (Hida, Japan, President: Osamu Ushimaru) announced that it has confirmed through human pharmacokinetic studies of its new quercetin formulation, EubioQuercetin, that the amount of quercetin used can be reduced to one quarter of the original amount.

Key Points: 
  • Co., Ltd. (Hida, Japan, President: Osamu Ushimaru) announced that it has confirmed through human pharmacokinetic studies of its new quercetin formulation, EubioQuercetin, that the amount of quercetin used can be reduced to one quarter of the original amount.
  • Health occupies a central position in the SDG 3, and quercetin is a supplement that plays a significant role in achieving this global goal.
  • To accomplish this, Alps Pharmaceutical has spent many years researching natural quercetin and has finally succeeded in developing EubioQuercetin, a new quercetin formulation made from only safe and natural food ingredients.
  • "Natural quercetin, found in fruits and vegetables, is fully absorbed by the body and contributes to good health.

ALPS PHARMA LAUNCHES A NEW QUERCETIN DELIVERY COMPOSITION

Retrieved on: 
Saturday, February 26, 2022

Key Points: 
  • Co., Ltd.(President: Osamu Ushimaru), a global pharmaceutical company pioneering phytochemicals in medicine and food, today announced the launch of a water-soluble Quercetin delivery composition, Eubioflavonoid derived from Sophora Japonica, which delivers more Quercetin to the body in a smaller dose.
  • Eubioflavonoid, a Quercetin delivery formula protected by three related U.S. patents, has demonstrated significantly higher absorbability than ordinary Quercetin in a human pharmacokinetics study.
  • This time, by using a newly developed delivery system, we succeeded in delivering the Quercetin Glycoside to the intestines and dramatically improving the absorption rate of Quercetin in the body.
  • A database of human clinical studies of Quercetin and Quercetin glycosides for health maintenance and promotion since 2011 can be found at the following website:
    Since its founding in 1947, ALPS Pharmaceutical Ind.

ALPS PHARMA LAUNCHES A NEW QUERCETIN DELIVERY COMPOSITION

Retrieved on: 
Saturday, February 26, 2022

Key Points: 
  • Co., Ltd.(President: Osamu Ushimaru), a global pharmaceutical company pioneering phytochemicals in medicine and food, today announced the launch of a water-soluble Quercetin delivery composition, Eubioflavonoid derived from Sophora Japonica, which delivers more Quercetin to the body in a smaller dose.
  • Eubioflavonoid, a Quercetin delivery formula protected by three related U.S. patents, has demonstrated significantly higher absorbability than ordinary Quercetin in a human pharmacokinetics study.
  • This time, by using a newly developed delivery system, we succeeded in delivering the Quercetin Glycoside to the intestines and dramatically improving the absorption rate of Quercetin in the body.
  • A database of human clinical studies of Quercetin and Quercetin glycosides for health maintenance and promotion since 2011 can be found at the following website:
    Since its founding in 1947, ALPS Pharmaceutical Ind.

ALPS PHARMA LAUNCHES A NEW WATER-SOLUBLE ISOQUERCETIN COMPOSITION WITH HIGHER ABSORPTION RATE

Retrieved on: 
Saturday, February 26, 2022

Key Points: 
  • Co., Ltd. (President: Osamu Ushimaru), a global pharmaceutical company that pioneered the use of phytochemicals in medicine and food, announced the launch of a new Isoquercetin composition, EubioIsoquercetin, today.
  • EubioIsoquercetin derived from Sophora Japonica is expected to deliver more Quercetin to the body via small doses of Isoquercetin.
  • EubioIsoquercetin, a water-soluble Isoquercetin composition, protected by three related U.S. patents, demonstrated a significantly higher Quercetin absorbability rate than ordinary Isoquercetin in a human pharmacokinetics study.
  • EubioIsoquercetin is only formulated with all natural food ingredients and is the first formula to achieve a higher absorption of Quercetin into the body without enzymatic modification.

ALPS PHARMA LAUNCHES A NEW WATER-SOLUBLE ISOQUERCETIN COMPOSITION WITH HIGHER ABSORPTION RATE

Retrieved on: 
Saturday, February 26, 2022

Key Points: 
  • Co., Ltd. (President: Osamu Ushimaru), a global pharmaceutical company that pioneered the use of phytochemicals in medicine and food, announced the launch of a new Isoquercetin composition, EubioIsoquercetin, today.
  • EubioIsoquercetin derived from Sophora Japonica is expected to deliver more Quercetin to the body via small doses of Isoquercetin.
  • EubioIsoquercetin, a water-soluble Isoquercetin composition, protected by three related U.S. patents, demonstrated a significantly higher Quercetin absorbability rate than ordinary Isoquercetin in a human pharmacokinetics study.
  • EubioIsoquercetin is only formulated with all natural food ingredients and is the first formula to achieve a higher absorption of Quercetin into the body without enzymatic modification.