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December 02, 2015
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.
October 23, 2015
The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards
September 28, 2015
The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.
September 01, 2015
The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.
July 27, 2015
EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.
July 16, 2015
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.