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Volume X, Number 298

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EAASM Report on Patient Safety and Nanomedicines Calls for Centralized Regulatory Procedure

On September 17, 2020, the European Alliance for Access to Safe Medicines (EAASM) announced the availability of a report entitled Patient Safety and Nanomedicines:  The need for a centralised regulatory procedure.  According to EAASM, “[n]anomedicines and their follow-on products, also referred to as nanosimilars, are complex molecules and so regulatory oversight must be scientifically fit for purpose.”  The report makes three key recommendations intended to ensure patient safety and enable the European Union (EU) to harness fully the potential of this technology:

  • Developing a scientific consensus on definitions for nanomedicines in Europe, improving education and fostering awareness on the complexity and sophistication of nanomedicines among policy makers, prescribers, payers, and patients;

  • Adopting a European Medicines Agency (EMA) centralized procedure for all nanomedicines and nanosimilars that would ensure greater scrutiny of these complex products; and

  • Clarifying regulatory criteria for the approval of follow-on/nanosimilar medicines. As manufacturing exact replicas of nanomedicines is not achievable, therapeutic similarity will need to be shown through clinical evidence.  In addition, the highest possible manufacturing standards must be guaranteed and included in the license application.

EAASM states that with the upcoming EU Pharmaceutical and Industrial Strategies, “it is the right time to set the scene for building a pan-European medical agency consensus so that regulatory weaknesses can be addressed through a robust regulatory pathway and thus provide medicines with the highest quality, safety and efficacy profiles to European patients.”  This applies not only to existing medicines but also to “the plethora of new medicines that are in the pipeline.”  The report calls upon the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE), EMA, and Member States’ health authorities and regulatory bodies to address unmet medical needs and enhance quality, safety, and efficacy of nanomedicines and nanosimilars by addressing patient safety issues due to significant regulatory challenges across Europe.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 273
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About this Author

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...

202-557-3801
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.

202-557-3809
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