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ENATRANS Compedium for successful translation - testing, regulation and reimbursement of Nanomedicine

The translation of any new medical invention, including nanomedicine, into a final product is a highly regulated and complex process. The process can be roughly divided into a pre-clinical and clinical trials part - governed by regulation agencies such as the European Medicines Agency (EMA) or National Agencies - and in continuation, into a part dealing with pricing and reimbursement issues, which are mainly handled by national or regional authorities. The compendium is a public document elaborated by ENATRANS WP3 to give a broad overview of this regulatory ecosystem and issues to be aware of on the way from research proof of concept to the patient. It can be used for both distinct procedures for pharmaceutical (medicinal) products and for medical devices and in vitro diagnostic products as kind of a guidance listing the requirements and processes for the three main areas: preclinical and clinical regulations plus reimbursement. In June 2017, the compendium has been augmented with insights in regulation processes for 6 Countries outside Europe (USA, China, Japan, Brazil, India, South Korea).
Contact:

Should you have any question or require further information related to the ecosystem of Nanomedicine, please contact:

Dr. Klaus-Michael Weltring
Gesellschaft für Bioanalytik Münster e. V.
Tel. +49 (0)251 38450333
weltring@bioanalytik-muenster.de

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