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White Paper Identifies Challenges Associated with Regulating Nanotechnology-Enabled Health Products in the EU

The European Commission’s Joint Research Center (JRC) recently published a white paper entitled Anticipation of regulatory needs for nanotechnology-enabled health products.  The white paper notes that at this time, “no specific regulatory framework exists for nanotechnology-enabled health products but the current regulatory practice requires additional guidance in order to fully cover the particularities of such products.”  The white paper identifies the following major challenges associated with regulating nanotechnology-enabled health products:

  • Depending on their mode of action, nanotechnology-enabled health products are regulated either as medicinal products or medical devices. Due to the increased complexity of such products and their size-related properties, the selection of the regulatory path may be challenging since the primary mode of action might be difficult to determine.

  • Due to the rapid progress in the field and the lack of robust data sets, only limited guidance on regulatory information needs is currently available, and the question remains whether the identified requirements in this initial guidance are sufficient for a reliable characterization and assessment of all nanotechnology-enabled health products. To generate the required information on the quality, safety, and efficacy of the products, standardized testing methods have to be available.

  • As patents expire for certain nanomedicinal products, generic versions of the innovator products will require access to the market. Since the physicochemical characteristics can be very complex for nanotechnology-enabled products and achieved through sophisticated manufacturing processes, the current regulatory practice to assess the equivalence of the products may not be sufficient.  More guidance is needed on how the similarity of follow-on products can be demonstrated and suitable standardized methods assessing the (bio) equivalence of such products need to be developed.

  • The European Union (EU) definition of nanomaterials will apply for nanotechnology-enabled medical devices, outlining their classification and regulatory requirements. The implementation of the definition and the classification rule, introducing the need to define the internal exposure to nanomaterials, pose additional challenges, however.

The white paper states that the regulatory challenges it highlights “should guide the research projects and the involved communities willing to advance the regulatory science in the area of nanotechnology-enabled health products.”

©2019 Bergeson & Campbell, P.C.

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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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