European Medicines Agency--more transparency needed.

摘要

On May 10, 2010, the European Medicines Agency (EMA, formerly EMEA) published a draft recommendation from the European Ombudsman Nikiforos Diamandouros who called on EMA to reconsider its refusal to give access to documents relating to isotretinoin, which is used to treat severe acne. EMA protects and promotes Europe's public health through assessment and supervision of medicines, which is mainly the collation and dissemination of information about adverse reactions to medicines throughout the European Union (EU). EMA receives information on suspected adverse reactions to drugs from competent authorities in EU member states, as well as from drug companies themselves.