Biomedical Engineering Reference
In-Depth Information
entirely new system would invite. Invariably, however, when the use of existing rules is raised for
comment, the question arises as to whether that framework is relevant and/or adequate to address
issues suggested by nano products. Here, the most pertinent question is often whether the proposed
products fit into the existing scheme, or are so “new” that the original benefit-to-risk equations do
not adequately address the risks posed by the products.
In some countries, there may not be a comprehensive body of regulations available for possible
adaptation. While authorities consider what to do, they often times encourage voluntary action by
the regulated industry.
At the other end of the spectrum, governing bodies may consider enactment of mandatory regu-
lation of the entire class of products, or they may propose regulation of products on a case-by-case
basis, as needed. Typically, such action so early in the life cycle of the products involved only fol-
low-up reports of health hazards where regulatory action is mandated. Absent is the need to address
pressing public health issues, the aim of any of these mechanisms will likely be to collect relevant
information first. The government can be expected to seek information on products that are in dis-
tribution, or proposed for sale, that contain nanomaterials and whether they are labeled as such, who
is producing them, the type of manufacturing safeguards that are utilized, and related questions.
A regulator can seek to obtain this information by asking manufacturers and developers to sub-
mit it voluntarily. It could be done by formulating a variety of data requests and publishing them
widely. Voluntary action could be as simple as advising anyone proposing to sell a pharmaceutical
or medical product utilizing nanotechnology to contact the regulator and discuss what, if any, action
should be undertaken prior to going to market. The ultimate effectiveness of voluntary action is, of
course, quantitative information that is forthcoming and the development of information on prod-
uct performance establishes that the products generally present little or no risk. Also, information
obtained can be useful, but only if everyone subject to regulation responds. Otherwise, an incom-
plete, and perhaps false, picture can be created of an industry.
Mandatory regulations, at least as to notification and identification of the use of nanomaterials,
is more likely to be enacted, while at the same time deferring any premarket approval until more
is known about what should be required in any such applications. The initial activity is often the
agreement on a definition of the substance or product to be regulated, so the affected industry and
the public will know what is being addressed. The next objective is to establish an inventory of
products being sold, so that the regulator and the public are not “blind.” Such regulations usually
require registration of companies and locations of manufacture and distribution, and notification of
products sold or to be sold. An integral part of the notification about products being sold is to know
the intended uses and the product labeling meant to reflect those uses. Hand-in-hand with that is
information on any adverse effect in the marketplace from use, and from clinical studies done on
the product or similar products for the intended use involved.
At that point, the regulator will begin to accumulate the information likely to forestall a major
product failure, and then go on to formulate proposals for dealing with the risks presented by premar-
ket submissions or conformance to standards. Given the paucity of hard information from studies
involving nanomaterials, the regulator may also seek to encourage meaningful testing. Eventually,
the shape of the data requirements may be best governed by regulations detailing the information
necessary to demonstrate safety and, perhaps, effectiveness.
While it is still in the early days with respect to the commercialization of nanomaterials for phar-
maceuticals and medical products, many nations and multinational entities are beginning to con-
front the situation in earnest. In the space provided, it is not possible to address in detail each such
global effort. Instead, the following sections will address in some detail efforts in the United States,
the European Union (EU), and countries such as Canada and Australia, since collectively each has
progressed the farthest in dealing with the challenge presented by the marketing of pharmaceuticals
and medical products incorporating or produced using nanomaterials, and the effect that the testing,
production, and use of those materials in products might have on the environment. The regulations
and guidances put forward to date will be presented in the words of the regulator, so the reader can
