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February 17, 2016
UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.
February 09, 2016
The agency prepares a plan to implement new packaging safety features.
February 01, 2016
The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.
December 10, 2015
EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.
December 02, 2015
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
November 30, 2015
The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.
November 16, 2015
The new executive director of the European Medicines Agency begins appointment.
November 06, 2015
The European agency presents guidelines for conducting post-authorization efficacy studies.
November 02, 2015
The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.