Clinical Trials - June 13, 2014
EMA presents new policy on clinical trial data
The European Medicines Agency has agreed on policy on publication of clinical trial data with more user-friendly amendments. This will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic […]
Drug Development Pharma - April 9, 2014
EMA introduces new fee incentives for SMEs
The European Medicines Agency has introduced new fee incentives to support micro, small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use.
Clinical Trials - March 21, 2014
EMA launches adaptive licensing pilot project
The European Medicines Agency (EMA) is now inviting companies to participate in its adaptive licensing pilot project. Any company who is interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases, states the agency in a press release. The adaptive licensing approach, sometimes called staggered approval […]
Drug Development Pharma - February 5, 2014
SMEs drive behind innovative medicine
Over 40% of innovative medicines recommended for marketing authorisation in the European Union between 2010 and 2012 originated from small or medium-sized enterprises, says EMA. According to an article published recently in Nature Reviews Drug Discovery, authored by staff members of the European Medicines. Agency (EMA), small or medium-sized enterprises (SMEs), academia, public bodies and […]
Drug Development Pharma - January 9, 2014
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies. Studies […]
Drug Development Pharma - November 8, 2013
EMA seeks information on AstraZeneca’s Brilinta
The European Medicines Agency has contacted AstraZeneca asking the company to provide more information about a U.S. probe into a clinical trial of the company’s new blood thinner Brilinta (ticagrelor), reports Reuters. On November 7 EMA said that it contacted AstraZeneca earlier after the U.S. Department of Justice probe was disclosed by the company on October […]
