Tag Archives: European Union
By Guest Blogger | Published: September 24, 2014
What can be gleaned about the direction that health policy will take for the next five years under the new European Commission, scheduled to take office at the beginning of November? Peter O’ Donnell address this question in his new Applied Clinical Trials column here.
By Jill Wechsler | Published: September 24, 2014
Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
By Guest Blogger | Published: August 12, 2014
The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, […]
By Reflector | Published: July 18, 2014
It’s difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start. With a new European Parliament installed, a new European Commission president appointed and a new Commission on the way, and guarded optimism that the worst of the […]
By Guest Blogger | Published: July 17, 2014
By Philip Ward, Applied Clinical Trials. The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.