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Mapping Nanomedicine Terminology in the Regulatory Landscape Mapping Nanomedicine Terminology in the Regulatory Landscape Quirós Pesudo, Laia Balahur, Alexandra Gottardo, Stefania Rasmussen, Kirsten Wagner, Gerhard Joanny, Geraldine Bremer-Hoffmann, Susanne 2018 EUR 29291 EN This publication is a Technical report by the Joint Research Centre (JRC), the European Commission’s science and knowledge service. It aims to provide evidence-based scientific support to the European policymaking process. The scientific output expressed does not imply a policy position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use that might be made of this publication. Contact information [email protected] JRC Science Hub https://ec.europa.eu/jrc JRC112224 EUR 29291 EN PDF ISBN 978-92-79-89872-3 ISSN 1831-9424 doi:10.2760/753829 Print ISBN 978-92-79-89873-0 ISSN 1018-5593 doi:10.2760/404274 Luxembourg: Publications Office of the European Union, 2018 © European Union, 2018 The reuse policy of the European Commission is implemented by Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Reuse is authorised, provided the source of the document is acknowledged and its original meaning or message is not distorted. The European Commission shall not be liable for any consequence stemming from the reuse. For any use or reproduction of photos or other material that is not owned by the EU, permission must be sought directly from the copyright holders. How to cite this report: Quirós Pesudo, L.; Balahur, A., Gottardo, S., Rasmussen, K., Wagner, G., Joanny, G. and Bremer-Hoffmann, S., Mapping Nanomedicine Terminology in the Regulatory Landscape, EUR 29291 EN; Publications Office of the European Union, Luxembourg, 2018, ISBN 978-92-79-89872-3, doi:10.2760/753829, JRC112224 All images © European Union 2018, except: cover, ibreakstock, 2018. Source: stock.adobe.com Contents 1 Introduction ..................................................................................................... 9 2 Methodology ................................................................................................... 11 2.1 Information sources ................................................................................... 11 2.1.1 Bibliographic databases .............................................................................. 11 2.1.2 Regulatory authorities' websites .................................................................. 11 2.1.3 Clinical trial registries database ................................................................... 13 2.1.4 Patent database ........................................................................................ 13 2.2 Data collection and analysis ........................................................................ 16 2.2.1 Step 1: Keyword extraction and keyword set construction .............................. 16 2.2.1.1 Automatic keyword extraction .................................................... 17 2.2.1.2 Bibliographic search engines ...................................................... 17 2.2.1.3 Manual keyword extraction ........................................................ 18 2.2.1.4 Keyword sets construction ......................................................... 18 2.2.2 Step 2: Methods for mapping nanomedicine terminology ................................ 19 2.2.2.1 Web Crawling and metadata extraction ....................................... 20 2.2.2.2 Keyword set matching and analysis ............................................ 20 2.2.3 Step 3: Methodology for collection of term descriptions .................................. 21 2.3 Internationally activities contributing to a standardised terminology ................ 22 2.3.1 Glossaries and non-standardised terminologies ............................................... 23 3 Results .......................................................................................................... 25 3.1 Step 1: Construction of a nanomedicine keyword sets .................................... 25 3.1.1 Bibliometric analysis: capturing keywords in bibliographic sources ................... 25 3.1.2 Description of the final keyword set for nanomedicine .................................... 30 3.1.3 Selection of a reduced keyword set for manually mapping identified sources ..... 33 3.2 Step 2: Mapping nanomedicine terminology in information sources .................. 34 3.2.1 Summary of terminology mapping ............................................................... 34 3.2.2 Mapping of keywords in regulatory authorities' websites ................................. 36 3.2.3 Mapping in clinical trial registries ................................................................. 41 3.2.4 Mapping in patents .................................................................................... 44 3.3 Step 3: Compilation of information and term descriptions ............................... 46 3.3.1 Compilation of relevant documentation from regulatory sources ...................... 46 3.3.2 Compilation of descriptions of relevant terms ................................................ 52 3.4 Discussion on selected nanomedicine terms .................................................. 53 3.4.1 Nanomedicine ........................................................................................... 53 3.4.2 Nanomedicines .......................................................................................... 54 3.4.3 Nanomaterial ............................................................................................ 55 i 3.4.4 Nanotechnology ........................................................................................ 56 3.4.5 Nanoscale................................................................................................. 56 3.4.6 Nanostructure ........................................................................................... 57 3.4.7 Nanosimilars ............................................................................................. 57 3.4.8 Nanodevice ............................................................................................... 58 3.4.9 Theranostic products (or theranostics), Combination products, and Borderline products......................................................................................................... 58 4 Final remarks and conclusion ............................................................................ 60 4.1 Challenges and next steps .......................................................................... 63 List of abbreviations ............................................................................................ 65 List of figures ...................................................................................................... 66 List of tables ....................................................................................................... 67 Annexes ............................................................................................................. 69 Annex 1 Description of bibliometric search engines .............................................. 70 A1.1 Automatic extraction with Tools for Monitoring Innovation (TIM) ............. 70 A1.1.1.Keyword and topic visualisation .......................................................... 70 A1.2 Automatic extraction with GoPubMed ................................................... 71 Annex 2 List of keywords automatically extracted with bibliometric search engines .. 72 A 2.1 List of keywords automatically extracted with TIM for nanomedicine ......... 72 A2.2. List of keywords automatically extracted with TIM for nano and medical devices ...................................................................................................... 75 A2.3 List of keywords automatically extracted with GoPubMed .......................... 78 Annex 3 Description of nanomedicine materials and products in the literature ......... 79 Annex 4 Mapping regulatory authorities' websites ................................................ 88 Annex 5 Description of selected nanomedicine terms ............................................ 93 A5.1 Nanomedicine ................................................................................... 93 A5.2 Nanomedicines .................................................................................. 94 A5.3 Nanomaterial .................................................................................... 96 A5.4 Nanotechnology ................................................................................ 99 A5.5 Nanoscale ....................................................................................... 100 A5.6 Nanostructure ................................................................................. 101 A5.7 Nanosimilars ................................................................................... 101 A5.8 Nanoparticle ................................................................................... 101 A5.9 Magnetic nanoparticles (SPIO, SPION, USPION) .................................. 103 A5.10 Metal nanoparticles .......................................................................... 104 A5.11 Polymer therapeutics ....................................................................... 104 A5.12 Polymeric nanoparticle ..................................................................... 105 A5.13 Polymeric micelle (block copolymer micelle) .......................................
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