کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10520561 954185 2013 4 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Thérapie innovante : du cadre réglementaire européen au cadre réglementaire national
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی ایمونولوژی
پیش نمایش صفحه اول مقاله
Thérapie innovante : du cadre réglementaire européen au cadre réglementaire national
چکیده انگلیسی
The European regulation no 1394/2007/CE published on the 13th of November 2007 defined and harmonized the European regulatory framework for advanced therapy medicinal products. It creates a specialized committee located at the European Medicine Agency, in charge of the assessment of these medicinal products. The consequences of this regulation are introduced in the French regulation by the law no 2011-302 published on the 22nd of March 2011. It detailed notably the possibility for public establishments (except health establishments) and nonprofit organisms to create pharmaceutical establishments. This law defined also a specific category of advanced therapy medicinal products, which fall under the “hospital exemption” framework. The rules regarding the authorizations of the establishments able to prepare these types of medicinal products and the authorization of the products are defined by the no 2012-1236 decree published on the 6th of November 2012.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Transfusion Clinique et Biologique - Volume 20, Issue 2, May 2013, Pages 221-224
نویسندگان
,