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April 02, 2016
The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.
April 01, 2016
The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.
March 07, 2016
The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.
March 02, 2016
The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.
February 29, 2016
The agency has revised its good pharmacovigilance practices guide on risk management systems.
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.