Why the Adoption of Nanotechnology in Medicine and Biomedicine isn’t as Fast as it Could Be? – Part 4: Delayed Nanoregulation

Most sciences and technologies develop faster than regulators can regulate. This is no secret.

Altough this is “normal”, the special case of nanotechnology and its adoption in several fields (including medicine and biomedicine) may be critical. While nanotechnology shows a huge potential for tremendous benefits, this emerging and fast developing field of science and technology also s has the potential to engender a wide range of dangers, risks and menaces.

According to the Científica Limited’s great report “The Nanoparticle Drug Delivery Market Report”, “there are long admission procedures including for example several clinical trials. Due to the close interface between technology and Human beings there is a special velocity of development which is reflected in long and preferably well defined admission procedures, including for example several clinical trials. In some cases, it is not the nanoparticles to be the constraint or limiting factor but the pharmaceuticals. Most of the basic things that will slow many developments will certainly be the lack of understanding of complex biological systems”.

While regulation has been discussed for a long time there has been little in the way of concrete action.  Nevertheless, many other organizations have demonstrated significant efforts in order to develop a qualified work in nanoregulation, for example regulatory entities such as the United States Environmental Protection Agency and the Health & Consumer Protection Directorate of the European Commission already started working with the potential risks of nanoparticles.

Still according to Científica Limited’s report The Nanoparticle Drug Delivery Market Report”, “market development is being slowed down by lack of regulatory case law, manifest over public concern over the potential health and environmental impacts of manufactured nanoparticles. This will be improved as new products emerge onto the market and more in the United States especially, this is attracting attention and investigation from governmental organisations, and strong collaborations are being set up with academia, with particular regard to the International Council on Nanotechnology (ICON), established at Rice University’s Center for Biological and Environmental Nanotechnology, is conducting comprehensive safety studies for the FDA”.

The Organisation for Economic Co-operation and Development (OECD) is also working on Safety of Manufactured Nanomaterials.

The World Health Organization (WHO) is developing Guidelines for “Protecting Workers from Potential Risks of Manufactured Nanomaterials” in order to address occupational risks of nanomaterials.

In 1995, the Inter-Organization Programme for the Sound Management of Chemicals (IOMC) was founded to strengthen cooperation and increase coordination in the field of chemical safety. The IOMC organizations organize regular meetings together to ensure co-ordination. At these meetings, the status of activities related to nanotechnology has been discussed.

The WHO together with Food and Agriculture Organization (FAO) of the United Nations is providing member states with scientific advisory on the assessment of foods related to nanotechnology.

Finally, during the current year, regulatory entities have shown a significant increase in work regarding concerns about nanosafety. Almost everyday Google news provides us with up-to-date advances in nanoregulation with the FDA being especially active  regarding the adoption of nanotechnology in medicine and biomedicine.

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