Nanotechnology

MHRA aims to remain well aware of scientific information as it becomes available that informs the debate about the risks and benefits in this area. To this end we:

1. have organised a conference, entitled 'Nanotechnology: Impact on Health and Regulation'
2. participate in relevant cross-governmental and international committees
3. have summarised the data available thus far on the toxicology of healthcare nanoparticles and are obtaining expert advice from relevant advisory committees on this information.

MHRA nanotechnology conference
The conference 'Nanotechnology: Impact on Health and Regulation' was held successfully in October 2005. The programme included several international speakers provided stimulating talks and participants ranged across the whole range of MHRA stakeholders. Freely downloadable copies of the conference presentations are available.

External committee activity
The MHRA has made a significant contribution to the initial work of an EU Medical Devices Expert Group exercise aiming to establish whether the risks by devices made from, or incorporating nanotechnology, are adequately addressed in the general Medical Devices Directive (external link). We will continue to participate.

The MHRA is a member of both the DTI-led Nanotechnology Issues Dialogue Group (NIDG) (external link) as well as the Defra-led Nanotechnology Research Funding Group (NRCG) (external link). In November 2005, the NRCG produced a first research report setting out a programme of research objectives to characterise the potential risks posed by nanotechnologies, with a particular focus on nanoparticles. This report described ongoing activities and funding mechanisms to address research priorities. The research objectives are being taken forward by five dedicated task-force groups. NRCG have in October 2006 published a progress report (external link) on this project.

Toxicology of healthcare nanoparticles
There are many excellent, published reviews of 'nanotoxicology'. An example is the opinion published in March 2006 by the European Committee’s Scientific Committee on Emerging and newly Identified Health Risks (SCENIHR) on the appropriateness of existing risk assessment methodologies for nanotechnology products. One of the conclusions of the many nanotoxicology reviews, including the SCENIHR opinion, tends to be that there isn’t yet enough data to derive systematic rules that govern toxicological characterisation of the nanotechnology products. Another is that there might be new hazards associated with loose nanoparticles.

The possibility of new hazards is very much of interest to MHRA because this could mean specific nanoparticle-data requirements need to be implemented to ensure patient safety. MHRA thus asked themselves the question: “Several groups have identified that there might be new hazards. With all the nanotechnology research going on, has any evidence for new hazards relevant to healthcare products actually been found yet?"

In this context it is also worth noting that the nanoparticles used in healthcare applications differ in several fundamental ways from the ones most investigated and reported upon. Historically much of the nanotoxicology data has originated from air pollution data. This means a preponderance of respiratory data involving non-biodegradable, non-deformable and often highly surface reactive, complex particles. A lot of the fundamental data gathering with model nanoparticles has also involved non-biodegradable, non-deformable spheres such as polystyrene and latex or more recently fullerenes and carbon nanotubes. This is not the typical profile for nanoparticles used in healthcare.

The MHRA has thus summarised the toxicological data publicly available that is relevant to healthcare nanoparticles. The main conclusion that MHRA has come to after reviewing this enormous amount of data was: there is currently no evidence for the actual existence of any such new hazard!

To put this conclusion into context, there are significant data gaps and thus the emergence of a new hazard cannot be excluded with the present state of knowledge, but there is currently no evidence for the actual existence of any such hazard either. This conclusion is not fundamentally different form the one other reviews have come to, however, most reviews tend to emphasise the fact that they cannot exclude something else emerging in the future. The different profile of the typical healthcare nanoparticles means that the areas that cause most worry (such as persistence, possible distribution to the brain, etc.) are either less relevant or in some cases even an advantage for specific healthcare products.

Because of the implications on patient safety if we were to get it wrong, MHRA is submitting the review to scrutiny by relevant independent expert committees as well. The Committee on Toxicity of Chemical in Food, Consumer Products and the Environment (COT) (external link), has discussed this at their September 2006 meeting. Final minutes are still to be published, but based on these data members agreed that the mechanisms of toxicity seen with healthcare nanoparticles are not unique. The report was then presented at the September 2006 Commission on Human Medicines (CHM) meeting, where the members present also agreed that they weren't aware of any new mechanisms of toxicity and they all felt that the current methods of toxicology would pick up the hazards likely to be presented by healthcare nanoparticles, although the sensitivity of the methods might vary. The report will also be submitted to the Committee on the Safety of Devices (CSD) at their October 2006 meeting.

The report is available here as it was submitted to the CHM in September 2006.

› The toxicology of nanoparticles used in healthcare products (492Kb)

It is important that we base any decisions on whether or not nanotechnology specific rules or regulations are needed on the current state of science. This review does not currently indicate the need for nanotechnology specific regulations. This conclusion is broadly in line with the one published in June 2006 by the European Medicines Agency (EMEA reflection paper) and the one thus far tentatively arrived at by the Medical Devices Expert Group on New and Emerging Technologies. The Food and Drug Administration (FDA) in the United States has also concluded that the current requirements for safety testing of medicinal products is sufficiently rigorous and are currently believed to be adequate. At the present time the FDA has no specific testing requirements specific to nanotechnology products. However, because this is an area with severe data gaps, it is very important not to be complacent and continue to keep our eye on the ball. If research identifies toxicological risks that are unique to nanomaterials, additional testing requirements may be necessary.