The European Commission DG Enterprise and Industry has just closed a 3-month public consultation on the “Future of pharmaceuticals in Europe” in order to make Europe a hub for safe and innovative medicines.  EBE participated in the consultation on behalf of the European biopharmaceutical industry sector and made specific recommendations for improving the regulatory framework.

Brussels, 23 April 2007

EFPIA & EBE ask MEPs to make a swift adoption of the Advanced Therapies Regulation possible by supporting the new-cross party package

This will allow a first reading adoption of this urgently needed Regulation

Comments on the EMEA/CHMP/BMWP/246511/2005
Concept Paper on Guideline on Immunogenicity Assessment
of Therapeutic Proteins (EMEA/CHMP/BMWP/246511/2005)

EBE and EuropaBio members welcome the EMEA initiative in developing a Concept Paper for the release of a Guideline on Immunogenicity Assessment of Therapeutic Proteins.

Comments on the EMEA/CHMP/BMWP/9437/2006
Concept Paper on Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process - Non-Clinical and Clinical Issues

Comments on the framework for scientific advice & protocol assistance (EMEA/267187/2005)

In September 2005 the EMEA launched a set of questions and answers describing an improved procedure for Scientific Advice and Protocol Assistance for public consultation.

EBE Comments to the EMEA draft Operational Procedure on handling "consultation with target patient groups" on Package Leaflet for Centrally Authorised products for human use (EMEA/277378/2005)

EBE Comments on the EMEA Guideline on Clinical Trials in Small Populations (CHMP/EWP/83561/2005)

In March 2005 the EMEA Committee for Medicinal Products for Human Use (CHMP) issued a Guideline on Clinical Trials in Small Populations.

EBE, the Emerging Biopharmaceutical Enterprises representing more than 65 biopharmaceutical companies in Europe welcomes the EMEA’s initiative to consult interested parties in the creation of guidance to facilitate clinical trials for which there are few patients available.