Biomedical Engineering Reference
In-Depth Information
Both publications followed requests for advice from the European Commission. While finalizing
its outputs, EFSA took into account feedback received from public consultations. EFSA's Panels
also consider the safety of specific nanomaterials, for instance in the areas of food additives and
food contact materials.
15.9.3 M
edIcal
d
evIce
aNd
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harMaceutIcal
Finally, the European Medicines Agency addresses issues regarding nanomaterials in medical devices
and pharmaceuticals. On its website, the Agency states that “nanotechnology has only partially been
exploited in medicine” and “is being investigated as a way to improve the properties of medicines,
such as their solubility or stability, and to develop medicines that may provide new ways to:
•
Deliver medicines to the body
•
Target medicines in the body more accurately
•
Diagnose and treat diseases
•
Support the regeneration of cells and tissues”
*
Going forward, the Medicines Agency describes its activities in the area of nanotechnology as:
The European Medicines Agency follows the latest developments in nanotechnology that are relevant
to the development of medicines. Recommendations from the Agency's Committee for Medicinal
Products for Human Use (CHMP) have already led to the approval of a number of medicines based on
nanotechnology. These include medicines containing:
•
Liposomes (microscopic fatty structures containing the active substance), such as Caelyx
(doxorubicin); Mepact (mifamurtide), and Myocet (doxorubicin)
•
Nano-scale particles of the active substance, such as Abraxane (paclitaxel), Emend (aprepi-
tant), and Rapamune (sirolimus)
The development of medicines using newer, innovative nanotechnology techniques may raise new
challenges for the Agency in the future. These include discussions on whether the current regulatory
framework is appropriate for these medicines and whether existing guidelines and requirements on the
way the medicines are assessed and monitored are adequate.
†
The Agency also needs to consider the acceptability of new testing methods and the availability of
experts to guide the Agency's opinion-making.
‡
Again, the language on the website echoes what the FDA is saying about its activities.
The CHMP mentioned by the European Medicines Agency is the committee responsible for
preparing opinions on questions concerning medicines for human use. The members and alternates
of the CHMP are nominated by European Union Member States in consultation with the Agency's
Management Board. They are chosen on the strength of their qualifications and expertise with
regard to the evaluation of medicines and serve for a renewable period of three years. In 2009,
the CHMP established the
ad-hoc
expert group meeting on nanomedicines. This group includes
selected experts from academia and the European regulatory network, which support the Agency's
activities by providing specialist input on new scientific knowledge and help with the review of
guidelines on nanomedicines. The group also helps the Agency's discussions with international
partners on issues concerning nanomedicines.
*
European Medicines Agency—Medicines and emerging science—Nanotechnology. http://www.ema.europa.eu/ema/
index.jsp?curl=pages/special_topics/general/general_content_000345.jsp&mid=WC0b01ac05800baed9.
†
Id.
‡
Id.