THE EUROPEAN Medicines Agency (EMA) has advised pharma companies on updating the information held by regulators on their authorised medicines. EMA said that from June 16 to December 31 this year, marketing-authorisation holders must refile information on their medicines using a new data submission format, bring information up to date and check information against updated reporting requirements. *http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&mid=WC0b01ac058079126c 6141 – BIG PHARMA BEING CHALLENGED IN INNOVATION BY SMALLER PLAYERS – EMA
February 1st, 2014
MORE than 40% of innovative medicines recommended for marketing authorisation in the European Union (EU) between 2010 and 2012 came from small or medium-sized enterprises (SMEs), academics, public bodies and public-private partnerships, according to European Medicines Agency (EMA) officials. Writing a paper for the Nature Reviews Drug Discovery academic journal, they found that 27% of approved medicines during these years came from SMEs. They indicated that some of these smaller businesses were prolific, given SMEs account for only 13% of EU ...
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