EMA
EMA under fire for blocking data access
June 8, 2010Research and Development, Sales and Marketing Acomplia, Alli, EMA, Xenical, data
The European ombudsman has called for the European Medicines Agency to grant access to clinical study reports and trial protocols …
EMA eyes stem cell research breakthrough
May 18, 2010Research and Development EMA, Stem cells, stem cell
European regulators are readying themselves to deal with the region’s first marketing authorisation application for a stem cell product. The …
EMA readies paediatric trials network
May 14, 2010Research and Development EMA, EMEA, paediatric, paediatric trials
The European Medicines Agency is about to press the start button on its long-planned network for clinical studies in children. …
EMA transparency criticised
May 11, 2010Sales and Marketing EMA, Roaccutane, patient information
The European Medicines Agency (EMA) has been given a rap over the knuckles by the European Ombudsman for a perceived …
EMA appoints Alexis Nolte head of quality
May 7, 2010Manufacturing and Production EMA, appointment, manufacturing and production
The European Medicines Agency has appointed Alexis Nolte to head up its Quality of Medicines Sector. He was previously principal …
CHMP in brief: Hospira’s Nivestim approved
March 22, 2010Research and Development EMA
A round-up of decisions from the Committee for Medicinal Products for Human Use (CHMP), including its recommendation for a chewable version …
Single orphan document will simplify process for industry
March 1, 2010Research and Development EMA, FDA, Orphan
The FDA and European Medicines Agency are to simplify the regulatory process for orphan medicines by agreeing to accept a …
Digital Pharma: New EMA website previewed
February 3, 2010Research and Development, Sales and Marketing EMA, branding, digital pharma
The European Medicines Agency is preparing to overhaul its website to make it easier for users to get information. This …
Transatlantic conversations
January 11, 2010Research and Development EMA, FDA
The Pharmafocus interview: Murray Lumpkin, FDA Deputy Commissioner for International ProgramsCollaborations between the world’s leading medicines regulators have increased markedly …
EMA: Aligning regulation with the lifecycle of medicines
November 30, 2009Research and Development EMA, EMEA, Thomas Lönngren, regulatory affairs
The European Agency for the Evaluation of Medicinal Products was set up in 1995 in London’s Docklands, an isolated eastern …
Lonngren lashes out at late warning
November 1, 2004EMA, EMEA, Lonngren, Vioxx
Thomas Lonngren, the head of Europe’s medicines regulator the EMEA has spoken out about Merck’s withdrawal of Vioxx, saying the …
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