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Ecosystem of Nanomedicine

The translation of any new medical invention into a final product is a highly regulated and complex process. This section gives an overview of the broader nanomedicine ecosystem and issues to be aware of such as regulation, pricing and reimbursement systems by providing all data about these steps in place in Europe, at the EU, and Member States level.

Nanomedical Ecosystem

Ecosystem of Nanomedicine

 

The translation of any new medical invention into a final product is a highly regulated and complex process. This section gives an overview of the broader nanomedicine ecosystem and issues to be aware of such as regulation, pricing and reimbursement systems by providing all data about these steps in place in Europe, at the EU, and Member States level.

 

To bring a new medical product or device on the market it has to go through a long and complex process involving many authorities at regional, national and international level. To successfully manage this process it is mandatory to study and understand the different parts of the process in detail. The following sections will provide information, links and downloads to serve as a guide about what is required in which order and who can help at the different steps of the process.

The process can be roughly devided into a market authorisation part - governed by regulation agencies such as the European Medicines Agency (EMA) or National Agencies -, a clinical trials part and, in continuation, the pricing and reimbursement systems mainly handled by national or regional authorities. To receive details about these three fields please follow the links below. The fourth link gives a first overview of some international regulations.

Find guidance, links and contacts to address these issues in the downloadable Compendium available here (PDF, 914 KB)


If you need additional information or help do not hesitate to contact us directly.

 

Ecosystem of Nanomedicine

EU Regulatory Process  >> International Regulatory Processes >> Clinical trials >>  Pricing and Reimbursement

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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