Proposal for new European pharmaceutical legislation to permit access to custom‐made anti‐sense oligonucleotide medicinal products

Article date: June 2014

By: John D. Johnston, Peter Feldschreiber, in Volume 77, Issue 6, pages 939-946

Current European pharmaceutical legislation is not adequate to meet advances in science and technologies that will lead to rapid development of custom‐made medicines. Using existing legislation for custom‐made medical devices as a template and anti‐sense oligonucleotides as model medicinal products, we propose new European pharmaceutical legislation to permit timely access to custom‐made anti‐sense oligonucleotide medicinal products. The proposals may be more widely applicable to other medicinal products.

DOI: 10.1111/bcp.12250

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