News & Alerts
US FDA publishes Draft Guidance for Industry on Drug Products, Including Biological Products, that Contain Nanomaterials
Posted on 18 Dec 2017
The United States Federal Drug Administration has published a draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials on 18 December 2017
Posted on 14 Jun 2017
ECHA has just launched the European Union Observatory for Nanomaterials (EUON). The EUON is a website in 23 EU languages that will aim to give citizens, workers and professionals access to information on nanomaterials on the EU market. The EUON will be launched in 3 steps, with additional information being made available at each step and is...
Posted on 23 May 2017
NIA was part of a multi-project consortium that delivered the 2 day workshop "Nanomaterials: Industrial workshop on Safe by Design" in Bilbao on April 24-25, managed by the project Nanogentools. Projects dedicated to building the concept and tools behind Safe by Design came together, including:
Posted on 5 May 2017
NIA welcomes publication of the JRC Science for Policy Report 'NANoREG framework for the safety assessment of nanomaterials'. The comprehensive report was co-authored by NIA's David Carlander from the collaborative work within the NANoREG project "A common European approach to the regulatory testing of nanomaterials", funded by the European...
Posted on 21 Apr 2017
NIA is delighted to be sharing a stand at the EuroNanoForum 2017 with Joanneum Research, University of Leeds, INERIS,Tutech and National Research Centre for the Working Environment (NRCWE). The stand will hold discussion groups, workshops and other activities including a showcasing of industry developments in new sectors, safe-by-design tools and...
Posted on 6 Apr 2017
6 April saw the launch of NIA's new regulatory service to Members, a monthly Regulatory Digest. This newsletter will provide an ongoing review of regulatory changes and processes relevant to NIA members, activities from NIA within those processes and support available to Members.
Posted on 31 Mar 2017
NIA Members and the wider nano community came together in Brussels on a sunny spring day to lift the lid on latest global regulatory news and take a look at Safer by Design as a tool in sustainable business.
Council releases Position on Medical Devices Regulation ahead of European Parliament committee vote on 21 March - UPDATE
Posted on 13 Mar 2017
On 7 March 2017, the Council of the European Union released its position with a view to the adoption of a Regulation on Medical Devices. The Council, the European Parliament and the Commission had reached an agreement in June 2016.
Posted on 22 Jun 2016
On 15 June 2016, the three institutions of the European Union reached an agreement on the Regulation on Medical Devices. The Council, the European Parliament and the Commission had engaged in a trilogue procedure after the vote of the European Parliament in April 2014
Posted on 9 Mar 2016
On 24 February 2016, the European Economic and Social Committee (EESC) of the European Union published an own-initiative Opinion on ‘Nanotechnology for a competitive Chemical Industry’, which states 'the importance of nanotechnology should also be more strongly reflected and supported in the EU’s priorities.’
Posted on 8 Mar 2016
On 27 January 2016, the French government enacted the Law for the Modernisation of Our Healthcare System (Loi 2016-41 pour la Modernisation de notre Système de Santé). It commits the French Government to deliver a report on nanomaterial use in medicines and medical devices to the French Parliament by 18 months (June 2017)
US NIOSH opens consultation on Health Effects of Occupational Exposure to Silver Nanomaterials Publication
Posted on 3 Feb 2016
Late January 2016, the US National Institute for Occupational Safety and Health (NIOSH) has released a draft document on the Health Effects of Occupational Exposure to Silver Nanomaterial. This document contains a literature review as well as recommendations for the safe handling of silver nanoparticles and research needs to fill in data gaps and...
Posted on 10 Dec 2015
The Danish Environmental Protection Agency (EPA) has released the final report of the 'Better Control of Nanomaterials' initiative
SCENIHR Position Statement flags Nanomaterials in Medical Imaging and Drug Delivery and Graphene as Emerging Issues
Posted on 10 Apr 2015
The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published a Position Statement on emerging and newly identified health risks to be drawn to the attention of the European Commission; this document was adopted at the plenary of the scientific committee of 20 November 2014
Posted on 6 Jan 2015
The EC SCENIHR has published its final opinion on the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices. This follows a consultation to which eleven organisations, including NIA, responded
Posted on 1 Dec 2014
NIA Member Endomagnetics has announced that it ‘has received Investigational Device Exemption (IDE) approval from the US FDA’ for two of its medical devices, the SentiMag® and the Sienna+®. This approval allows the company ‘to initiate a pivotal [multisite] clinical trial to evaluate the effectiveness of’ the devices
Posted on 30 Jul 2014
The EC e-magazine CORDIS Express has devoted its latest issue to looking ‘at a range of research projects focused on developing new applications for nanomaterials as well as honing the risk assessment process’. These projects include applications in medical applications, art restoration, energy and electronics, as well as those related to...
NIA EXCLUSIVE Members Consultation: EU SCENIHR Guidance on the Determination of Potential Health Effects of Nanomaterials used in Medical Devices - Deadline: 29 September 2014
Posted on 22 Jul 2014
NIA Members are invited to contribute to NIA's reply on the SCENIHR consultation on the Guidance on the Determination of Potential Health Effects of Nanomaterials used in Medical Devices
Posted on 17 Jul 2014
EC SCENIHR has published a draft opinion, Guidance on the Determination of Potential Health Effects of Nanomaterials used in Medical Devices. The Committee concludes that ‘the potential risk is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure’, and is ‘dependent on the method of...