rarediseases
A European Commission proposal to tighten conditions in which Advanced Therapy Medicinal Products (ATMPs) may benefit from a special exemption for use in hospitals has divided health stakeholders with concerns about the lack of EU-wide data and calling for guarantees on the specific use conditions. The principle of hospital exemption (HE) was first introduced in the EU regulation for ATMPs - medicines for human use based on genes, tissues or cells, and are mainly used to treat rare diseases - in 2007 to allow some treatments to be used without marketing authorisation under certain specified ci...
Euronews (English)
The impact on Advanced Therapy Medicinal Products (ATMPs) is one of the key emerging flashpoints of European Commission proposals to revise the EU’s pharmaceutical legislation which were tabled in April last year. ATMPs are medicines for human use based on genes, tissues or cells, and are mainly used to treat rare diseases, 80% of which are genetic and can be targeted by these innovative treatments. Although ATMPs have transformed treatment of rare diseases, high production and research costs make them inaccessible for many patients. Of 18 gene therapies authorised for EU use in recent years, ...
Euronews (English)
閲覧を続けるには、ノアドット株式会社が「プライバシーポリシー」に定める「アクセスデータ」を取得することを含む「nor.利用規約」に同意する必要があります。
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