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

Abstract

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. © 2013 The British Pharmacological Society.