Regulatory aspects on nanomedicines

V Sainz, J Conniot, AI Matos, C Peres… - Biochemical and …, 2015 - Elsevier
… on the most important aspects currently recognized as key factors for the regulation of
nanomedicines, discussing the efforts under development by industry and regulatory agencies to …

[HTML][HTML] Nanomedicine: principles, properties, and regulatory issues

S Soares, J Sousa, A Pais, C Vitorino - Frontiers in chemistry, 2018 - frontiersin.org
… This process must be also carried out along with interagency harmonization efforts, to
support rational decisions pertaining to scientific and regulatory aspects, financing and market …

Regulatory considerations, challenges and risk-based approach in nanomedicine development

I Csóka, R Ismail, O Jójárt-Laczkovich… - Current Medicinal …, 2021 - benthamdirect.com
… This paper aims at reviewing the status and regulatory aspects of nano-based drug … )
regulations. In addition to discussing the ris s accompanied by the development of nanomedicine, …

Nanotechnology and nanomedicine in market: a global perspective on regulatory issues

S Devasahayam - Characterization and biology of nanomaterials for drug …, 2019 - Elsevier
… enable a harmonized global regulatory framework founded on … aspects. It considers whether
a legal metrology framework (LMF) needs to be developed for NT, including nanomedicine

Clinical aspects and regulatory requirements for nanomedicines

V Tambe, R Maheshwari, Y Chourasiya… - Basic fundamentals of …, 2019 - Elsevier
nanomedicines by collaborating with various organizations in the EU enabling a platform for
both scientific and regulatory aspects. … at an early stage of nanomedicines development and …

[HTML][HTML] Regulatory issues surrounding nanomedicines: setting the scene for the next generation of nanopharmaceuticals

R Gaspar - Nanomedicine, 2007 - Taylor & Francis
… Indeed, the current regulatory framework has proved to be sound enough until now. A first
generation of nanomedicines (nanopharmaceuticals) got access to the market in a regulated

Nanomedicine: an unresolved regulatory issue

VSW Chan - Regulatory Toxicology and Pharmacology, 2006 - Elsevier
Nanomedicine, which involves the use of nanotechnology in drug development, offers ever
… The difference between nanomedicine and conventional drugs is that nanomedicine is …

Pharmaceutical regulation of nanomedicines: principles and challenges

IR Lousa - 2024 - repositorio.ul.pt
… uncertainty and the lack of criteria for manufacturers, nanomedicines often end clinical …
evaluating nanomedicines and that analysing them on a case-by-case basis, based on …

Updated regulatory considerations for nanomedicines

TS Subin, V Vijayan, KJR Kumar - Pharmaceutical …, 2017 - ingentaconnect.com
… While there are many international initiatives to harmonize the regulatory
nanopharmaceuticals, and developments process with strategies tailored to upcoming regulations

Reviewing the regulatory barriers for nanomedicine: global questions and challenges

DM Bowman, J Gatof - Nanomedicine, 2015 - Taylor & Francis
… Accompanying document to the communication from the commission to the parliament,
the council and the european economic and social committee-regulatory aspects of …