EMEA and Gene Therapy Medicinal Products Development in the European Union

Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.

In the European Union (EU) herbal medicinal products have become increasingly important. This is, for instance, underlined by the recent introduction of a simplified procedure in the Member States of the EU allowing the registration of herbal medicinal products which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient evidence of its medicinal use throughout a perio...

The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/CVMP/315/98 - FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE: DEVELOPMENT PHARMACEUTICS FOR VETERINARY MEDICINAL PRODUCTS RELEASED FOR CONSULTATION BY CVMP

Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera

The first commercially approved human gene therapy in the Western world is Glybera (alipogene tiparvovec), which is an adenoassociated viral vector encoding the lipoprotein lipase gene. Glybera was recommended for marketing authorization by the European Medicines Agency in 2012. The European Medicines Agency had only ever reviewed three marketing authorization applications for gene therapy medi...

The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead i...

The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use

In December 2000, following 10 cases of life-threatening cardiac disorders including ventricular rhythm disorders such as Torsade de pointes reported in patients treated with Orlaam (levacethylmethadol), the European Medicines Evaluation Agency's (EMEA) scientific committee, the Committee for Proprietary Medicinal Products (CPMP), had decided, as an interim and precautionary measure while perfo...