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July 10, 2014
The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.
July 01, 2014
European Medicines Agency clarifies advanced-therapy medicinal products classification.
June 12, 2014
EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.
June 06, 2014
Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.
June 04, 2014
EMA publishes revised guideline on the acceptability of names for drugs.
May 15, 2014
EMA opens registration for it's sixth annual workshop on pediatric drug research and development.
EMA and ECHA sign agreement to share information and work together on risk assessments.
May 02, 2014
The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.
April 30, 2014
The European Medicines Agency's Annual Report highlights drug approvals, projects, and initiatives for 2013.
April 14, 2014
EMA sends its results on Roche investigation of pharmacovigilance non-compliance to the European Commission.