Fimea specifies the classification of red yeast rice preparations
Fimea will now classify red yeast rice preparations as medicines if the monacolin K compound content in their daily dose is 10 mg or higher.
Preparations will be analysed for classification purposes on a case-specific basis, depending on their effects and indication. Classification as a medicine will be based on Sections 3 and 6 of the Medicines Act.
Red yeast rice contains monacolin K, whose structure and pharmacological effects are identical to lovastatin, which is used as a cholesterol medication. Red yeast rice is prepared by fermenting white rice with Monascus purpureus, which is a naturally occurring fungus, not a synthetic substance. For this reason, the active substance content of the compound varies depending on factors such as production conditions, temperature, light and air humidity.
Product classification based on indication:
If a product containing red yeast rice is intended for a therapeutic indication, the product is considered a medicinal substance regardless of the daily dose of monacolin K.
Product classification based on effect:
If a product containing red yeast rice is not intended for a therapeutic indication, Fimea is of the opinion that those red yeast rice products whose daily dose contains less than 10 mg of monacolin K compound should not be considered medicines as referred to in Section 3 of the Medicines Act.
Fimea considers products to be medicines if their daily dose contains precisely 10 mg or more monacolin K.
If necessary, Fimea will provide guidance for self-employed persons and the general public concerning the details that must be taken into account in the classification of red yeast rice preparations. Red yeast rice preparations may contain several different monacolins and other active substances that affect the classification of an individual product.
Red yeast rice preparations studied as cooperation between authorities (News 1 December 2015)
Evira report: Red yeast rice investigation (in Finnish, PDF)
- Liisa Näveri, Head of Section, tel. +358 29 522 3340
- Kristiina Pellas, Senior Pharmaceutical Inspector, tel. +358 29 522 3422
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