title: Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.
abstract: The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed.
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; D005786:Gene Expression Regulation / Q000187:drug effects; D006801:Humans; D007880:Legislation, Drug; D009690:Nucleic Acid Conformation; D016376:Oligonucleotides, Antisense / Q000737:chemistry / Q000378:metabolism / Q000627:therapeutic use*; D010330:Patents as Topic; D011050:Policy Making; D057285:Precision Medicine; D012313:RNA / Q000737:chemistry / Q000378:metabolism*
chemical_list: D016376:Oligonucleotides, Antisense; D012313:RNA
keywords: Europe; RNA; antisense oligo-nucleotide; highly personalized medicine; pharmaceutical regulation