title: 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.
authors.affiliation: c/o 1102-35 Indescon Square, London, UK.
authors.forename: John D
authors.initials: JD
authors.lastname: Johnston
authors.forename: Peter
authors.initials: P
authors.lastname: Feldschreiber
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D007880:Legislation, Drug; D016376:Oligonucleotides, Antisense / Q000600:supply & distribution*
chemical_list: D016376:Oligonucleotides, Antisense
keywords: Europe; RNA; anti-sense oligonucleotide; custom-made medicine; personalized medicine; pharmaceutical regulation
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