eXTReMe Tracker
Gene Therapy Net RSS feed Follow Gene Therapy Net on Twitter LinkedIn - Gene Therapy Net discussion group Facebook - Gene Therapy Net

International Consortium

Related Links

New EU initiatives to optimize the interplay between the Pharma and the GMO framework

Posted on: 18 July 2018, source: European Commission
The EU's Regulation on advanced therapies, is designed to ensure the free movement of advanced therapy products within Europe, to facilitate access to the EU market, and to foster the competitiveness of European companies in the field, while guaranteeing the highest level of health protection for patients. A Good Practice document on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified has been developed by the national competent authorities and the Commission services.


Tekst}}

This document, which builds on possibilities under the existing legislation to facilitate the conduct of clinical trials with this type of medicinal products, has been endorsed by Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany Greece, Hungary, Italy, Luxembourg, Malta, Portugal, Romania, Spain, Sweden and Norway. Developers that intend to conduct a clinical trial in these countries can follow the approach laid down in this document.

Moreover, a common application has been endorsed by the competent authorities in Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Hungary, Italy, Luxembourg, Malta, Portugal, Romania, Spain and Norway.

Read full story ┬╗
Posted on: 18 July 2018, source: European Commission
The EU's Regulation on advanced therapies, is designed to ensure the free movement of advanced therapy products within Europe, to facilitate access to the EU market, and to foster the competitiveness of European companies in the field, while guaranteeing the highest level of health protection for patients. A Good Practice document on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified has been developed by the national competent authorities and the Commission services.
{fastsocialshare}

Register to read more ...