Editorial Feature

Regulatory Issues and Risk Assessment For The Safety Of Nanotechnology Based Medical Applications

The ageing population, the high expectations for better quality of life and the changing lifestyle of European society call for improved, more efficient and affordable health care.

Nanotechnology can offer impressive resolutions, when applied to medical challenges like cancer, diabetes, Parkinson's or Alzheimer's disease, cardiovascular problems, inflammatory or infectious diseases.

Experts of the highest level from industry, research centers and academia convened to prepare the present vision regarding future research priorities in NanoMedicine. A key conclusion was the recommendation to set up a European Technology Platform on NanoMedicine designed to strengthen Europe's competitive position and improve the quality of life and health care of its citizens. This article has been extracted from the vision paper “European Technology Platform on NanoMedicine - Nanotechnology for Health” produced by the European Commission.

Regulatory Issues and Risk Assessment

The acceptance of NanoMedicine necessitates transparent and timely information of all stakeholders, including the general public. Safety aspects of NanoMedicine have to be properly and systematically addressed, and there has to be a clear positive benefit-to-risk ratio that will accompany the clinical implementation of products and procedures based on nanotechnology. This will be achieved by a combination of evidence-based public awareness programmes and the development of science-based regulatory processes, which have to take risk management into account, e.g. by adopting a system, which identifies and assesses risks at every stage of the product or process cycle from the concept to post-treatment.

All medical products in Europe are currently regulated according to well-established Directives relating to medicinal products or to medical devices, according to their principal mode of action.

Discussions are also underway to provide a regulatory framework for human tissue engineered products and their associated processes. It is extremely important that any new risks that may be associated with the introduction of nanotechnology into clinical medicine are evaluated, and that the details of new risk management procedures identified as being relevant to this assessment are properly incorporated into the existing regulatory frameworks and are fully integrated into any new regulatory developments that may emerge in the future as being necessary to complement existing European legislation.

It is necessary to put into place measures that identify the hazards associated with novel nanotechnology based therapies, characterize the associated risks, reduce those risks as far as reasonably practicable, establish a positive risk/benefit balance and communicate the nature of any residual risks and other relevant safety information to doctors, patients and other key stakeholders. These risks could relate to, for example, patients, medical personnel and those working in production. There is a possible role for standards in this process. A harmonized systematic risk management standard already exists for medical technology products and could form the basis for a risk management protocol for medical nanotechnology. In addition, existing harmonized standards relating to biological safety could be reviewed and revised as necessary to take account of the specific characteristics of medical nanotechnology products.

An approach to the safe, integrated and responsible introduction of nanotechnology into medical practice should thus be included at a fundamental scientific level, to assess all aspects of risk and to contribute to appropriate regulations for this new technology, so that safety for patients and others is maximised whilst, at the same time enabling the benefits of NanoMedicine to be realised in a timely manner and in a way that encourages innovation and technological development. This approach is fully in line with the Commission’s European strategy for nanotechnology set out in the Communication “Towards a European Strategy for Nanotechnology” and it’s associated Action Plan.

Source: European Commission

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