Tuesday, October 7, 2014
The EMA has decided to publish clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA management board unanimously adopted the new policy Oct. 2. It will apply to clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken. The policy will enter into force in January 2015.
Micro, small and medium-sized enterprises (SMEs) are a motor of innovation in the European Union (E.U.). Between 2010 and 2012, more than one in four new innovative medicines recommended for marketing authorization in the E.U. originated from SMEs, as shown in an analysis published by the EMA in January.
Cancer Core Europe—a consortium to address the cancer care/research continuum challenge, has launched. Its members are Gustave Roussy Cancer Campus Grand Paris; Cambridge Cancer Center, based in the U.K.; Karolinska Institute, of Stockholm, Sweden; the Netherlands Cancer Institute; Vall d’Hebron Institute of Oncology (VHIO), of Barcelona, Spain; and the German Cancer Research Center (DKFZ) and its National Center for Tumor Diseases (NCT).