PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPE
Personalised medicine, with the aid of companion diagnostics, is a burgeoning field. The potential benefits of personalised medicine with regard to improved patient outcomes and reducing healthcare burden are recognised, but there remains obstacles that may limit growth in this area. Limitations inc...
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| Format: | Article |
| Language: | English |
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European Medical Journal
2017-01-01
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| Series: | European Medical Journal Innovations |
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| Online Access: | https://www.emjreviews.com/innovations/article/personalised-medicine-with-companion-diagnostics-the-intercept-of-medicines-and-medical-devices-in-the-regulatory-landscape/ |
| _version_ | 1818328358243532800 |
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| author | Amanda Craig |
| author_facet | Amanda Craig |
| author_sort | Amanda Craig |
| collection | DOAJ |
| description | Personalised medicine, with the aid of companion diagnostics, is a burgeoning field. The potential benefits of personalised medicine with regard to improved patient outcomes and reducing healthcare burden are recognised, but there remains obstacles that may limit growth in this area. Limitations include the current regulatory framework in many areas, in which the pharmaceutical is identified as a medicine, whilst the companion diagnostics are identified as a medical device; thus the two components may be governed and assessed by differing bodies and processes. This in turn results in disparity in approval times, patent and intellectual property claims, and reimbursement. Regulatory agencies are working together with industry and academia towards bridging these gaps, with significant inroads seen across the globe. |
| first_indexed | 2024-12-13T12:30:54Z |
| format | Article |
| id | doaj.art-eac0a7e9aa744fc298d230075f3810d1 |
| institution | Directory Open Access Journal |
| issn | 2513-8634 |
| language | English |
| last_indexed | 2024-12-13T12:30:54Z |
| publishDate | 2017-01-01 |
| publisher | European Medical Journal |
| record_format | Article |
| series | European Medical Journal Innovations |
| spelling | doaj.art-eac0a7e9aa744fc298d230075f3810d12022-12-21T23:46:02ZengEuropean Medical JournalEuropean Medical Journal Innovations2513-86342017-01-01114753PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPEAmanda Craig0Translational Neuroscience Facility and Department of Physiology, School of Medical Sciences, University of New South Wales, New South Wales, AustraliaPersonalised medicine, with the aid of companion diagnostics, is a burgeoning field. The potential benefits of personalised medicine with regard to improved patient outcomes and reducing healthcare burden are recognised, but there remains obstacles that may limit growth in this area. Limitations include the current regulatory framework in many areas, in which the pharmaceutical is identified as a medicine, whilst the companion diagnostics are identified as a medical device; thus the two components may be governed and assessed by differing bodies and processes. This in turn results in disparity in approval times, patent and intellectual property claims, and reimbursement. Regulatory agencies are working together with industry and academia towards bridging these gaps, with significant inroads seen across the globe.https://www.emjreviews.com/innovations/article/personalised-medicine-with-companion-diagnostics-the-intercept-of-medicines-and-medical-devices-in-the-regulatory-landscape/in vitro diagnostics (ivds)regulatory agenciesbiomarkersgenetic tests |
| spellingShingle | Amanda Craig PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPE European Medical Journal Innovations in vitro diagnostics (ivds) regulatory agencies biomarkers genetic tests |
| title | PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPE |
| title_full | PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPE |
| title_fullStr | PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPE |
| title_full_unstemmed | PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPE |
| title_short | PERSONALISED MEDICINE WITH COMPANION DIAGNOSTICS: THE INTERCEPT OF MEDICINES AND MEDICAL DEVICES IN THE REGULATORY LANDSCAPE |
| title_sort | personalised medicine with companion diagnostics the intercept of medicines and medical devices in the regulatory landscape |
| topic | in vitro diagnostics (ivds) regulatory agencies biomarkers genetic tests |
| url | https://www.emjreviews.com/innovations/article/personalised-medicine-with-companion-diagnostics-the-intercept-of-medicines-and-medical-devices-in-the-regulatory-landscape/ |
| work_keys_str_mv | AT amandacraig personalisedmedicinewithcompaniondiagnosticstheinterceptofmedicinesandmedicaldevicesintheregulatorylandscape |