Position papers 2011


Background Paper on the Legislative Framework for Orphan Medicinal Products

The Biotechnology Industry Organisation (BIO Deutschland), the trade association of the German biotechnology sector, aims to provide information in this background paper on the legal status and ramifications of European and German regulations on medicinal products for rare diseases (also known as orphan medicinal products or orphan drugs).



Statement on the revision of the guideline for the approximation of legislation and administrative regulations of the Member States about applying good clinical practice when conducting clinical trials with medicinal products for human use

BIO Deutschland agrees with the appraisal of the European Commission. A one-time submission via a joint 'EU portal' would in fact be welcomed. Such a procedure would bring about a significant relief in the administrative sector, especially with multinational clinical trials, as well as greatly reduced costs for the sponsors.



Position paper to current legislation about development and registration of Advanced Therapy Medicinal Products (ATMP)

The development of new therapies (like tissue engineered products and somatic cell - or gene therapy medicinal products) is positively evaluated everywhere and cited as a good example for high tech place Germany. Already the application of cellular therapeutical products leads to an improvement of patients’ treatment with certain diseases which have not be treated appropriately so far. Promising new approaches are developing. The new legislation EG 1394/2007 about advanced therapy medicinal products (ATMP) entered into force as from December 30, 2008, determining specific rules for registration and surveillance of medicinal products for new therapies.