Reviewing the Regulatory Barriers for Nanomedicine: Global Questions and Challenges

References

• Fleming A . The discovery of penicillin . Br. Med. Bull.2 ( 1 ), 4 – 5 ( 1944 ).
   Google Scholar
• Drews J . Drug discovery: a historical perspective . Science287 ( 5460 ), 1960 – 1964 ( 2000 ).
   PubMed Web of Science ®Google Scholar
• Croft S , CoombsG . Leishmaniasis – current chemotherapy and recent advances in the search for novel drugs . Trends Parasitol.19 ( 11 ), 502 – 508 ( 2003 ).
   PubMed Web of Science ®Google Scholar
• Rees J . Complex disease and the new clinical sciences . Science296 ( 5568 ), 698 – 700 ( 2002 ).
   PubMed Web of Science ®Google Scholar
• Collins F . The Language of Life: DNA and the Revolution in Personalized Medicine . Profile Books , NY, USA ( 2010 ).
   Google Scholar
• Schweitzer S . Pharmaceutical Economics Policy . Oxford University Press , Oxford, UK ( 2006 ).
   Google Scholar
• Friends of the Earth . Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks . Friends of the Earth , Melbourne, Australia ( 2006 ).
   Google Scholar
• Chaudhry Q , ScotterM , BlackburnJet al. Applications and implications of nanotechnologies for the food sector . Food Add. Contam.25 ( 3 ), 241 – 258 ( 2008 ).
   Web of Science ®Google Scholar
• Chaudhry Q . Nanotechnology for food applications: current status and consumer safety concerns . Presented at : AAAS Annual Meeting . IL, USA , 16 February 2009 .
   Google Scholar
• Bowman DM , CalsterGV , FriedrichsS . Nanomaterials and regulation of cosmetics . Nat. Nanotechnol.5 ( 2 ), 92 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Lenzer J . FDA is incapable of protecting us against anotherVioxx . BMJ329 ( 7477 ), 1253 ( 2004 ).
   PubMedGoogle Scholar
• Horton R . Vioxx, the implosion of merck, and aftershocks at the FDA . Lancet364 ( 9450 ), 1995 – 1996 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Horton R . Offline: a serious regulatory failure, with urgent implications . Lancet379 ( 9811 ), 106 ( 2012 ).
   Web of Science ®Google Scholar
• European Science Foundation . ESF Forward Look on Nanomedicine . ESF , Brussels, Belgium ( 2005 ).
   Google Scholar
• European Medicines Agency . Reflection Paper on Nanotechnology-Based Medicinal Froducts for Human Use . EMA , Brussels, Belgium ( 2006 ).
   Google Scholar
• European Technology Platform . Nanomedicine: Nanotechnology for Health . European Commission , Brussels, Belgium ( 2006 ).
   Google Scholar
• Wagner V , DullaartA , BockAK , ZweckA . The emerging nanomedicine landscape . Nat. Biotechnol.24 ( 10 ), 1211 – 1217 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Farokhzad OC , LangerR . Nanomedicine: developing smarter therapeutic and diagnostic modalities . Adv. Drug Deliv. Rev.58 ( 14 ), 1456 – 1459 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Riehemann K , SchneiderSW , LugerTA , GodinB , FerrariM , FuchsH . Nanomedicine – challenge and perspectives . Angew. Chem. Int. Ed. Engl.48 ( 5 ), 872 – 897 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Barenholz Y . Doxil – the first FDA-approved nano-drug: lessons learned . J. Control. Release160 ( 2 ), 117 – 134 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Etheridge M , CampbellS , ErdmanA , HaynesC , WolfS , McculloughJ . The big picture of nanomedicine: the state of investigational and approved nanomedicine products . Nanomedicine9 ( 1 ), 1 – 14 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Tinkle S , McNeilSE , MühlebachSet al. Nanomedicines: addressing the scientific and regulatory gap . Ann. NY Acad. Sci.1313 ( 1 ), 35 – 56 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• NanoFUSE® DBM . www.nanotherapeutics.com/nanofuse-dbm2/ .
   Google Scholar
• Royal Society and Royal Academy of Engineers . Nanoscience and nanotechnologies: opportunities and uncertainties ( 2004 ).
   Google Scholar
• HM Government . Response to the royal society and royal academy of engineering report: ‘nanoscience and nanotechnologies: opportunities and uncertainties’ ( 2005 ).
   Google Scholar
• Ludlow K , BowmanDM , HodgeGA . Review of possible impacts of nanotechnology on Australia’s regulatory framework ( 2007 ).
   Google Scholar
• Bowman DM , HodgeGA . A small matter of regulation: an international review of nanotechnology regulation . Columbia Sci. Technol. Law Rev.8 ( 1 ), ( 2007 ).
   Google Scholar
• MHRA . How we regulate nanotechnology . ( March 9, 2014 ).
   Google Scholar
• Committee on Human Medicines . The toxicology of nanoparticles used in healthcare products ( 2006 ).
   Google Scholar
• European Medicines Agency . Reflection paper on nanotechnology-based medicinal products for human use ( 2006 ).
   Google Scholar
• FDA Nanotechnology Task Force . Nanotechnology: a report of the (US) Food and Drug Administration ( 2007 ).
   Google Scholar
• Taylor MR . Regulating the products of nanotechnology: Does the FDA have the tools it needs? ( 2006 ).
   Google Scholar
• Centre for Food Safety and Applied Nutrition . Guidance for industry: safety of nanomaterials in cosmetic products – draft guidance ( 2012 ).
   Google Scholar
• Centre for Food Safety and Applied Nutrition . Guidance for industry: assessing the effects of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food contact substances, including food ingredients that are colour additives – draft guidance ( 2012 ).
   Google Scholar
• Faunce T , MurrayK , NasuH , BowmanD . Sunscreen safety: the precautionary principle, the australian therapeutic goods administration and nanoparticles in sunscreens . Nanoethics2 ( 3 ), 231 – 240 ( 2008 ).
   Google Scholar
• Therapeutic GoodsAdmnistration . Safety of sunscreens containing nanoparticles of zinc oxide or titanium dioxide . Department Health Ageing ( 2006 ).
   Google Scholar
• Therapeutic GoodsAdmnistration . Literature review on the safety of titanium dioxide and zinc oxide on nanoparticles in sunscreens . Department Health Ageing ( 2013 ).
   Google Scholar
• European Commission . Accompanying document to the communication from the commission to the parliament, the council and the european economic and social committee-regulatory aspects of nanomaterials . In-depth review of the effectiviness of the EU’s regulatory regimes for addressing nanotechnologies ( 2008 ).
   Google Scholar
• European Commission . Communication on regulation aspects of nanomaterials . European Commission , Brussels, Belgium ( 2008 ).
   Google Scholar
• European Commission . Second regulatory review on nanomaterials . European Commission , Brussels, Belgium ( 2012 ).
   Google Scholar
• European Medicines Agency . Non-clinical studies for generic nanoparticle iron medicinal products applications ( 2011 ).
   Google Scholar
• European Medicines Agency . Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product ( 2013 ).
   Google Scholar
• European Medicines Agency . Surface coatings: general issues for consideration regarding parental administration of coated nanomedicine products ( 2013 ).
   Google Scholar
• European Medicines Agency . Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product ( 2013 ).
   Google Scholar
• European Medicines Agency . Development of block-copoloymer-micelle medicinal products ( 2014 ).
   Google Scholar
• Ehmann F , Sakai-KatoK , DuncanRet al. Next-generation nanomedicines and nanosimilars: Eu regulators’ initiatives relating to the development and evaluation of nanomedicines . Nanomedicine8 ( 5 ), 849 – 856 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Bind Therapeutics . http://bindtherapeutics.com/technology/accurins.html .
   Google Scholar
• Kalarx . http://kalarx.com/about-us/overview/ .
   Google Scholar
• Linkov I , SatterstromK , CoreyL . Nanotoxicology and nanomedicine: making hard decisions . Nanomedicine4 , 167 – 171 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Fadel TF , SteevensJA , ThomasTA , LinkovI . Managing nanotechnology risk management . Nano Today ( 2015 ) ( Epub ahead of print ).
   Web of Science ®Google Scholar
• Oberdörster G . Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology . J. Intern. Med.267 , 89 – 105 ( 2009 ).
   Web of Science ®Google Scholar
• Nanomarkets . The impact of nanotechnology in drug delivery: global developments, market analysis and future prospects . Market Res. Reports Nanomarkets.www.pharmamanufacturing.com/whitepapers/2007/044/ .
   Google Scholar
• Miller J . Beyond biotechnology: FDA regulation of nanomedicine . Columbia Sci. Technol. Law Rev.IV , ( 2003 ).
   Google Scholar
• Jain K , KesharwaniP , GuptaU , JainNK . Dendrimer toxicity: let’s meet the challenge . Int. J. Pharmaceut.394 ( 1 ), 122 – 142 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Nijihara R , BalakrishnanK . Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties . Nanomedicine2 , 127 – 136 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Mehta MD . The future of nanomedicine looks promising, but only if we learn from the past . Health Law Rev.13 ( 1 ), 16 – 18 ( 2004 ).
   PubMedGoogle Scholar
• Cormick C . Why do we need to know what the public thinks about nanotechnology?Nano Ethics3 ( 2 ), 167 – 173 ( 2009 ).
   Google Scholar
• Gupta N , FischerARH , FrewerLJ . Ethics, risk and benefits associated with different applications of nanotechnology: a comparison of expert and consumer perceptions of drivers of societal acceptance . Nano Ethics9 ( 2 ), 1 – 16 ( 2015 ).
   Google Scholar
• Gaspar RS . Therapeutic products: regulating drugs and medical devices . In : International Handbook on Regulating Nanotechnologies . Edward Elgar , Cheltenham, UK , 291 – 320 ( 2010 ).
   Google Scholar
• Ohno Y . Ich guidelines – implementation of the 3Rs (refinement, reduction, and replacement): incorporating best scientific practices into the regulatory process . ILAR J.43 ( Suppl. 1 ), S95 – S98 ( 2002 ).
   PubMedGoogle Scholar
• Branch SK . Guidelines from the international conference on harmonisation (ich) . J. Pharmaceut. Biomed. Anal.38 ( 5 ), 798 – 805 ( 2005 ).
   PubMed Web of Science ®Google Scholar
• OECD . Six years of OECD work on the safety of manufactured nanomaterials: achievements and future opportunities ( 2012 ).
   Google Scholar
• Sylvester D , BowmanDM . Navigating the patent landscapes for nanotechnology: English gardens or tangled grounds?Methods Mol. Biol.726 , 359 – 78 ( 2011 ).
   PubMedGoogle Scholar
• Bawa R , BawaSR , MaebiusS , FlynnT , WeiC . Protecting new ideas and inventions in nanomedicine with patents . Nanomedicine1 , 150 – 158 ( 2005 ).
   PubMed Web of Science ®Google Scholar