EMA

The European Union's extensive transatlantic links have reached a further level of maturity with the completion at the end of 2014 of exchanges between the European Medicines Agency and Health Canada.

It is not only the specific issue of clinical trials rules that hangs in the balance as Europe shifts from 2013 to 2014.

A new call for proposals is going to appear in December from the Innovative Medicines Initiative, the European Union partnership with the pharmaceutical industry.

The annual worldwide antibiotic awareness event--celebrated in Europe on November 15--generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers.

A new report from the European Union grades member states on their orphan drug incentives.

Orphan drug development may take a back seat to profit and loss concerns.

Pharma's finger of blame once again points outward, never inward.

The pharma industry won't be the only group rewarded for conducting new pediatric research.

The EU’s newest draft legislation contains GCP rules that somehow aren’t already law.

Dismay over the level of anti-pharma feeling in the EU is not just "crying wolf."

Editors: David Machin, Simon Day, Sylvan Green (John Wiley & Sons, Ltd, 2004), 428 pages, hardcover, ISBN: 0471987875, £150

To present the new scheme as a time-saver rather than a time-waster, the new guidance points out that the data required is a subset of the data required in any case for the request authorization.

The EU offers up market advantages in exchange for pediatric trials.

In many parts of the globe, intended and actual effects of GCP legislation often differ.

The passing of the EU Directive deadline next month is unlikely to quell the stormy debate over its far-reaching impact.

ACT Editorial Advisory Board members are experts in their field who volunteer to review and comment on manuscripts being considered for publication. EAB members also provide valuable feedback on special programs and projects as well as keep our editorial staff current on the state of the industry. ACT would like to welcome two new members to our Editorial Advisory Board, Scott Grisanti and Uwe Gudat, as well as introduce them to our readers.

With increasing authority, the EMEA is indeed living in interesting times.

Find out what the new EU framework entails; a think tank finds that too much health care energy is going into medicine.

It may be known as "the old continent," but Europe sure as hell comes up with plenty of new rules.

Europe has a new system for pharmacovigilance for human medicines up and running. It's a data-processing network and database management system for dealing with Individual Case Safety Reports (ICSRs) in 18 countries-Iceland, Norway and Lichtenstein, in addition to the 15 European Union member states.

Even as the EU implementation deadline looms, clear clinical trial definitions remain elusive.

European Research Commissioner Philippe Busquin tours Africa to bring attention to the plight of developing nations unable to afford modern medicines.