Nanomedicine under supervision
Roszdravnadzor has started developing regulatory documents on the use of nanotechnology in medicine
FarmvestnikRoszdravnadzor has established a Scientific and Technical Council for the development of scientific approaches and methodological documents on regulatory aspects of the use of medical products created using nanomaterials and/or using nanotechnology.
The Council was headed by the head of Roszdravnadzor, Professor Nikolay Yurgel. The Scientific and Technical Council includes heads and specialists of research institutes, pharmacological departments and laboratories, medical universities of the country, the largest research and production companies, the press service of Roszdravnadzor reported.
Progress in the development of nanotechnology makes it relevant to develop two objectively related medical aspects. The first concerns the creation of a fundamentally new direction – nanomedicine, in which previously unknown technologies in medical practice will be developed and applied. The second medical aspect is related to the problems of assessing and confirming compliance of products and technologies of the nanoindustry with safety requirements and standards.
The assessment of the safety, effectiveness and quality of new nanoproducts is within the authority of Roszdravnadzor. Due to the novelty of this direction, scientific and methodological approaches to conducting pre–registration examination of such objects have not been developed at the moment. To solve these problems, a Council has been created, whose main functions will be to study the safety of medical use of nanomaterials, create an appropriate methodology, develop preclinical and clinical research methods, prepare draft regulatory legal and methodological documents on regulatory aspects of the circulation of medical products created with the help of nanotechnology.
In the near future, the Scientific and Technical Council plans to develop a draft dictionary of terms used in nanomedicine and the first edition of the supplement to the administrative regulations on registration of medicines produced using nanotechnology. Methodological recommendations will also be developed for preclinical safety assessment of nanoparticles intended for medical use. The activities of the Scientific and Technical Council will be regularly covered in specialized publications.
Portal "Eternal youth" http://vechnayamolodost.ru02.02.2010