International Harmonization of Regulation of Nanomedicine

Marchant, Gary E.; Sylvester, Douglas J.; Abbott, Kenneth W.; Danforth, Tara Lynn

doi:10.2202/1941-6008.1120

Cited by 19 publications

(9 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Medical standards related to ethics, environmental safety, and medical governance have been modifed to cover the introduction of NMs into the biomedical field [ 295 – 296 ]. Currently, the USA and the European Union (EU) have strong regulatory bodies and guideline legislation to control the potential risks of NMs.…”

Section: Reviewmentioning

confidence: 99%

Review on nanoparticles and nanostructured materials: history, sources, toxicity and regulations

Jeevanandam¹,

Barhoum²,

Chan³

et al. 2018

Beilstein J. Nanotechnol.

2,677

1,135

View full text Add to dashboard Cite

Nanomaterials (NMs) have gained prominence in technological advancements due to their tunable physical, chemical and biological properties with enhanced performance over their bulk counterparts. NMs are categorized depending on their size, composition, shape, and origin. The ability to predict the unique properties of NMs increases the value of each classification. Due to increased growth of production of NMs and their industrial applications, issues relating to toxicity are inevitable. The aim of this review is to compare synthetic (engineered) and naturally occurring nanoparticles (NPs) and nanostructured materials (NSMs) to identify their nanoscale properties and to define the specific knowledge gaps related to the risk assessment of NPs and NSMs in the environment. The review presents an overview of the history and classifications of NMs and gives an overview of the various sources of NPs and NSMs, from natural to synthetic, and their toxic effects towards mammalian cells and tissue. Additionally, the types of toxic reactions associated with NPs and NSMs and the regulations implemented by different countries to reduce the associated risks are also discussed.

show abstract

Section: Reviewmentioning

confidence: 99%

Review on nanoparticles and nanostructured materials: history, sources, toxicity and regulations

Jeevanandam¹,

Barhoum²,

Chan³

et al. 2018

Beilstein J. Nanotechnol.

2,677

1,135

View full text Add to dashboard Cite

show abstract

“…The main aim of harmonization in the research context has been to do away with differences among institutional, national, and regional policies, to make regulative systems more similar and compatible. There have been calls for harmonization in pharmaceutical research (Kidd 1996;Lee 2005;Molzon et al 2011), genomic research (Knoppers 2014;McGonigle and Shomron 2016;Townend 2018), observational medical research (Urushihara et al 2017;Lange et al 2019), nanomedicine (Marchant et al 2009), and various other medical research fields. In addition, there have been discussions about harmonization in relation to processing personal data (Hakulinen et al 2011), research ethics committees (Doppelfeld 2007), and institutional guidelines (Bonn et al 2017).…”

Section: What Is Harmonization Good For?mentioning

confidence: 99%

Research Ethics Codes and Guidelines

Sutrop¹,

Parder²,

Juurik³

2019

Handbook of Research Ethics and Scientific Integrity

View full text Add to dashboard Cite

Although the origin of professional codes of ethics can be traced back to ancient Greece, their peak was in the late twentieth century with more than 70% of codes of ethics being created after 1990. Today professional ethical standards are formulated as codes of ethics, sets of principles or guidelines, declarations, conventions, charters, or laws, and they differ in scope, form, and content. As there is no consensus on what is meant by "research ethics" and "research integrity," both concepts are clarified here.

show abstract

“…(Kika y Bowman, 2012). En este contexto, la regulación suave ha sido vista con particular interés como una herramienta para la armonización internacional y la coordinación de marcos regulatorios (Bowman y Hodge, 2007;Marchant et al, 2009). A pesar de la difusión sobre la regulación suave, las opiniones no son unánimes en lo que respecta a la evaluación de los resultados, tanto en términos de eficacia como de efectividad.…”

Section: La Regulación En La Política ¿Qué Tan Suave Debe Ser?unclassified

¿Qué tan suave debería ser la regulación nano? Identidades sociales y opiniones de los stakeholders italianos

Arnaldi

2015

View full text Add to dashboard Cite

RESUMEN: Después de revisar algunas de las iniciativas más relevantes de regulación suave en el campo de lo nano y de examinar algunos de los factores más relevantes que explican el reciente rol de la regulación suave en la gobernanza nanotecnológica, el presente trabajo explora las representaciones mutuas de los stakeholders italianos sobre la nanotecnología para mostrar cómo las consideraciones acerca de la identidad (percibida), en términos de motivaciones y roles en los procesos de regulación y comportamientos esperados en los actores sociales que están involucrados en el desarrollo de la nanotecnología, entran en los razonamientos de los actores para justificar la elección, apoyo o desecho de diferentes soluciones e instrumentos regulatorios, dígase la alternativa entre regulaciones suaves y regulaciones mandatorias.

show abstract

International Harmonization of Regulation of Nanomedicine

Cited by 19 publications

References 3 publications

Review on nanoparticles and nanostructured materials: history, sources, toxicity and regulations

Review on nanoparticles and nanostructured materials: history, sources, toxicity and regulations

Research Ethics Codes and Guidelines

¿Qué tan suave debería ser la regulación nano? Identidades sociales y opiniones de los stakeholders italianos

Contact Info

Product

Resources

About