New regulations on medical products and pharmaceuticals in Europe and the United States – An obstacle or an opportunity for chitosan?

Abstract of the oral presentation at 13th EUCHIS 31st May-3rd June 2017.

More than 2000 publications and 20 published clinical trials within the last 12 month show that chitosan and chitosan derivatives are still attractive for the medical industry. As producer of well defined and pure chitosans and chitosan derivatives for pharmaceutical applications, with more than one hundred different specification for chitosans on the market and around 300 production batches per year HMC is always on the pulse of the market and in contact with regulatories and pharmaceutical companies worldwide.

Following the PIP scandal about breast implants in Europe, the legal basis for medical products was extensively revised in the recent years. In April 2017 the new medical product regulations were adopted, which will also bring substantial changes in admission of chitosan-containing products for manufacturers. Those new regulations are binding legislative act for all EU countries. In addition, there are innovations in ISO standards and ICH guidelines regarding chitosan-based medical products and pharmaceuticals in Europe and the United States. The presentation will provide an overview of important changes for the pharmaceutical sector and effects on research, development and production of pharmaceuticals with chitosans.

Session 7, June 2nd;
13th International Conference of the European Chitin Sciety / 8th Symposium of the Iberoamerican Chitin Society,
Katja Richter, Heppe Medical Chitosan GmbH, Heinrich-Damerow-Str.1, 06120 Halle (Saale), Germany