EU Commission Regulation on Clinical Trial proposal
The EU Commission has published today the draft legal proposal on the revision of the regulatory framework for clinical trials in Europe.
EBE Executive Director (acting) Mrs Titta Rosvall-Puplett comments on the EU Commission proposed new regulation:
“Small and medium-sized companies have, together with academic researchers, suffered more than larger companies from the ‘red tape’ associated with the current rules. Complicated submission procedures that differ between countries are difficult to manage for companies with little experience and limited resources. The proposed single portal for submissions, and the concept of insurance based on the risk level of the clinical study are much welcomed by EBE members. We hope that the European Parliament and Member States will take our needs into account when they discuss the proposals”, says Titta Rosvall-Puplett.
For more information, please contact:
Titta Rosvall-Puplett, EBE Executive Director
Tel: +32 2 626 25 61 – Email: email@example.com
About EBE: European Biopharmaceutical Enterprises (EBE) is the Trade Association that represents biopharmaceutical companies of all sizes operating in Europe. It was established in 2000 as a specialised group of EFPIA and is headquarted in Brussels. Membership of EBE is open to all companies using biotechnology to discover, develop and bring new medicinal products to the market.