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"Nanotechnolgies" refer to technological fields concerning controlled manufacture of functional "nanosystems" or the deliberate creation of nanstructures that results in the production of entities with at least one in the "nano" scale. "Nano" comes from the Greek word meaning "dwarf" and, in a mathematical or scientific sense, means one billionth (10-9). Therefore, one nanometre (nm) is the same as one billionth of a metre (or about eighty thousandth the width of an average human hair). In science and technology it is generally taken to mean working with structures in the size range 5 to 100nm.
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Nanotechnology will provide huge opportunities not only to improve materials and medical devices but also to create new "smart" devices and technologies. It will accelerate scientific as well as economic activities in medical research and development.
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New nanomaterials being utilised in medical technology include carbon nanotubes. Carbon nanotubes are essentially elongated molecules, formed entirely from carbon atoms that possess many very interesting and useful physical characteristics, eg electrical, mechanical, thermal and optical. Properties currently under research include their ability to elongate or contract which may render them useful as sensors in a variety of medical devices (e.g. CO2 monitoring in anaesthesiology), and their remarkable flexibility and resistance to breaking.
Nanoporous materials, e.g. carbon-, silicon-, ceramic- or polymer- based, with holes in the region of 100nm, have greatly increased surface area and can have useful catalytic, adsorbent and absorbent properties. These may have valuable applications in implant technology or in drug delivery.
In the surgical field, nanotechnology is already being applied in several areas. Nanotechnological tools such as "optical tweezers" and "nanoscissors" can be used at the cellular level for cell manipulation and immobilisation. Essentially these devices use the forces arising from the momentum of, for example, laser light at particular tuned wavelengths to precisely reposition minute objects by steering the laser beam. This opens up the possibility of medical or surgical procedures at the cellular level.
Nanoformulates materials, e.g. silver nanoparticles, are already being incorporated into "smart" textiles that can be used for improved wound dressings with antibacterial properties.
Other areas also benefiting from nanotechnology include biosensors and biodetection, whereby nanotechnology is becoming increasingly used to detect metabolic changes very locally within the body with improved specificity and minimal invasiveness to the patient; imaging, in-vivo diagnosis and theranostics, where it is set to play a massive role in the development of more specific, accurate and less invasive diagnosis of diseases and metabolic states; and in-vitro diagnostics.
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For some time there has been a debate on the appropriateness and adequacy of the current legislative framework to cope with the challenges that the possible presence of nanoparticles in the body or the use of technology at nano level may bring about.
First of all it is important to underline that nanomedicine is not a new category of healthcare products, but rather a new enabling technology used in the design and production of medical devices and pharmaceuticals. For this reason, the first check to be made is whether a medical device that is CE marked in conformity to Directive 93/42/EEC is safe when it has been designed using or incorporating nanotechnology or whether a medicinal product, approved in conformity with Directive 2001/83/EC is safe when it has been designed using or incorporating nanotechnology.
Directive 93/42/EEC does not give prescriptive requirements, but requires that the manufacturer of a medical device takes responsibility for the performance and related safety of its products on the basis of an appropriately conducted and systematic risk management procedure. In conducting the analysis of the risks related to the product, the manufacturer has to take into account all relevant information he can gather on the technology and on the product at stake. This task is facilitated by the reference to harmonised standards for current and well-established technologies. For innovative technologies, the manufacturer has to be aware of the latest scientific data. Further products classified in class III, IIb or IIa shall be examined by an independent third party (Notified Body), which, under the control of the authorities of the Member State in which it is located, will confirm or challenge the conclusions of the manufacturer. The structure of the system seems to be appropriate to cope with any new emerging technologies incorporated into or applied to medical devices. This assessment has recently been recognised by an ad-hoc Working Group hosted by the European Commission, which has clearly indicated that the medical devices regulatory system is an appropriate framework to deal with nanotech-based medical devices. Nevertheless, the Commission is analysing if there is a need for specific guidance or supporting instruments, particularly concerning the classification of medical devices, for new technologies including products based on nanotechnology.
The legislative framework for medicinal products can be prescriptive both in terms of technical requirements and in terms of manufacturing, but flexibility is embedded provided that the applicant has scientifically sound justifications. The system is based on evaluation of the quality, safety and efficacy of the product, leading to a risk/benefit assessment and related risks minimization and management. Risk management may also be required in the post authorisation phase. Whenever a new technology is applied, the regulatory framework follows science by making new guidelines and where necessary, legal amendments to lay down appropriate requirements. In the absence of guidelines, applicants can seek scientific advice from the European Medicines Agency (EMEA) for issues relating to the development of their individual products that are not yet fully covered by existing guidance.
While the overall framework could be quickly complemented by new guidelines specific to nanotechnology (developed by EMEA or the Commission), the process for developing specific legal requirements for new technologies takes more time.
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The assessment procedures for medical devices and medicinal products both appear suitable for coping with the challenges of this new technology. While the medical devices system is likely to be able to cope with it effectively with relatively few amendments in a short time, the system for pharmaceutical products might require more extensive work. However, this should not delay patients' access to innovative medicines since there are procedures in place for guiding the applicants from the early stages of the development of their products even in absence of specific guidelines. A need for improved collaboration between regulators responsible for Medical Devices and Medicinal Products is strongly perceived, as integration of competences might be required for complex nanotechnology based products.
Imaging agents for system use are pharmaceuticals under the MPD (Medicinal Products Directives and Regulations), whereas scanners are treated under the MDD (Medical Device Directive). Due to the potential risks associated with pharmaceuticals, which are administered and used systematically in humans, the necessary series of laboratory, animal and clinical tests with different phases take longer time for market approval than the tests of medical devices. However, material that is "intended for research and development trials" (MPD Article 3.3) is not covered by the rules of the MPD.
In the USA, where the responsibility for the approval and oversight of clinical trials is centralised at the Food and Drug Administration (FDA), change has been introduced to speed up the development of diagnostic imaging agents. Recently the FDA has taken action to speed first-in-man assessments of imaging agents under the exploratory Investigational New Drug program. The FDA also developed new Guidance for Industry on Developing Medical Imaging Drug and Biological Products, which is intended to modernise the agency's approach for the approval of these types of agents recognising their relative safety as compared to therapeutic drug products.
In view of this, and in light of the benefits of molecular imaging it is the intention to form a working group, which will gain more insight on the risk level of imaging agents. As an accompanying action it is suggested to analyse the large amount of data that is available about the application of radiotracers in nuclear medicine and of magnetic resonance imaging-contrast agents in radiology over decades with hundreds of thousands of patients.
Source: 'Nanomedicine. Nanotechnology for Health', by the European Technology Platform, Strategic Research Agenda for Nanomedicine (November 2006)
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News : BBC, 24/03/07 Tiny implant could monitor cancer
The spread of cancer and the effect of drugs to combat it could be closely monitored using tiny implants. US researchers are perfecting a way to use microscopic particles which stick to chemicals in cancer cells and show up during scans. Their latest advance is to find a way to keep a supply of the particles inside the body for longer periods. Read the full article! |
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On 17 January 2007 the European Group on Ethics in Science and New Technologies (EGE) published an 'Opinion on the ethical aspects of nanomedicine' (download as PDF), following the request made by President Barroso in 2005. In the report, the EGE highlights several points, including the possibilities offered by nanomedicine "of new diagnostic, treatment and preventive methods that may open up promising areas of medicine".
With regards to safety, the EGE states that the safety levels which currently apply to medicine and medical technology should apply to nanomedical products. Additionally it recommends that it should be the European and national institutions in charge of protecting the safety of patients which should oversee the safety and security aspects of new tools and devices in nanomedicine. On the issue of risk assessment, the EGE has asked the European Commission to review existing legislations and propose any amendments which it feels is needed.
The EGE also indicates that there is currently no need for new regulatory structures focussing specifically on nanotechnology - existing regulations should be modified to incorporate changes. It does, however, indicate that the relevant authorities ensure that existing regulations be implemented in an unambiguous way to avoid uncertainty in the case of an overlap between regulations.
Read the full report!
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NEWS: Science Daily, 07/03/07 New probe detects breast cancer spreadA device capable of locating magnetic nanoparticles in lymph nodes to detect the spread of breast cancer has been developed by medical scientists in the UK and US. The device incorporates an ultra-sensitive magnetic probe to detect minuscule magnetic fields in the body. Read the full article! |
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BioDevice Partnering 2007 is your best business opportunity of the year to attend an international event targeting the innovative end of the medical technology industry, at the interface with sectors such as biotech/pharma, regenerative medicine, biomaterials and polymers.
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