As reported in the BiopharmaLife blog, the European Medicines Agency (EMEA) has received word from a European manufacturer that it plans to submit an application for marketing authorization for a stem cell based product. This is a 1st in the EU!
Normally, EMEA is tipped off by client companies approximately 4-6 months before the formal application is filed. Thus, the formal filing should take place late in the year in 2010. As yet, the company's identity is a secret.
This may signal just the beginning of a series of filings. To prepare, the EMEA has been meeting with pharma companies, US and Japan regulatory officials and academic experts in stem cell treatments.
Regenerative medicine may be beginning to make its appearance on a commercial stage and to get itself in position for initial use in treatments of cancers and damaged tissues.
Posted by Bruce Lehr May 15th 2010.
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