EuropaBio Submission to the Public Consultation Paper On Certification Quality & Non-Clinical Data For SMEs

04.07.2008

EuropaBio Submission to the Public Consultation Paper On Certification Quality & Non-Clinical Data For SMEs

Re: PUBLIC CONSULTATION PAPER ON CERTIFICATION OF QUALITY & NONCLINICAL DATA FOR SMALL AND MEDIUM-SIZED ENTERPRISES

Dear Mr Rossignol,

Thank you very much for the opportunity to input into the above consultation. EuropaBio is the European Association for Bioindustries, solely and uniquely bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 84 corporate members operating worldwide, 8 associate members, 6 BioRegions and 25 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research. Its mission is to promote an innovative and dynamic biotechnology-based industry in Europe.

The biotech industry has developed more than 200 drugs and vaccines that have helped millions of people worldwide. It currently counts for approximately 20% of all marketed medicines, and represents 50% of all medicines in the pipeline. These figures are significantly higher again in the field of rare diseases - a field affecting some 25-30 million Europeans, where biotech therapies offer the best chance for addressing these diseases (for which 70-80% have a genetic component) and where diagnosis and treatment often come too late.