Ocata Therapeutics Inc fka OCAT

[rocky301]

EU Orphan Designation,

Poster on Icell indicated the COMP meeting will NOT approve Orphan desig, rather the European Commission will. I did some digging and the following shows he is right. Thanks JHam for bringing it to light.

To benefit from the incentives, sponsors intending to develop an orphan medicine must submit an application to the Agency requesting 'orphan designation' for their medicine. The application is evaluated by the Agency's Committee for Orphan Medicinal Products (COMP), which provides its opinion on whether or not the medicine qualifies as an orphan medicine for the treatment, prevention or diagnosis of a rare disease. If the COMP issues a positive opinion, the European Commission may then grant the medicine orphan status.European Medicines Agency
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000034.jsp&murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac058002d4eb&jsenabled=false

5. If a medicinal product has already been granted orphan drug designation in the US or Japan, would this be automatically accepted for the EU?

No, the EU Regulation does not foresee recognition of orphan status granted in other regions. In addition, the criteria for orphan designation are not internationally harmonised. Orphan designation can only be granted in the EU, by the European Commission, once an application for designation has been reviewed by the Committee for Orphan Medicinal Products, in accordance with the procedure laid down in Article 5, Regulation (EC) 141/2000 of 16 December 1999.
http://www.ema.europa.eu/docs/en_GB/...C500003967.pdf

(COMP Positive opinion received 8-9 March 2011)
Human embryonic stem-cell-derived retinal pigment epithelial cells for treatment of Stargardt’s disease; TMC Pharma Services Ltd.
http://www.ema.europa.eu/docs/en_GB/...C500102965.pdf