EMA/FDA Documents

15/11/2016 EMA Orphan designation Neonatal encephalopathy
[https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1743]

14/11/2016 EMA Orphan designation Periventricular leukomalacia
[https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1744]

7/11/2016 EMA COMP Public summary of opinion on orphan designation Periventricular leukomalacia
[http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2016/11/WC500216104.pdf]

7/11/2016 EMA COMP Public summary of opinion on orphan designation Neonatal encephalopathy
[http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2016/11/WC500216120.pdf]

17/04/2015 EMA CAT Scientific recommendation on classification of advanced therapy medicinal products
[http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/03/WC500203714.pdf]