[PDF] Top 20 European Medicines Agency. Highlights 2008. Summary of the European Medicines Agency's annual report for 2008

... orphan-designated medicines demonstrate that their medicine offers a significant benefit over other available treatments, which is a necessary condition for receiving a marketing authorisation for an orphan ... See full document

... Initial evaluation covers activities relating to the processing of applications for medicinal products (orphans, non-orphans, biosimilars, generics, etc.) from pre-submission discussion with future applicants, through ... See full document

... The Agency coordinates the verification of com- pliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), good pharmacovigilance practice (GVP) ... See full document

... The Agency completed 2 urgent safety restriction (USR) procedures for centrally authorised products during 2004, introducing warnings into the marketing authorisation of the two medicinal ...The Agency ... See full document

... In 2005, the CVMP also reconsidered its previous opinion on the referral procedure for Micotil 300 (tilmicosin), initiated in 2004 to investigate concerns regarding user safety following an accidental human fatality ... See full document

... the Agency recommended the variation of three previously authorised mock-up pandemic-influenza vaccines to include the H1N1 virus strain, making them effectively available for use during an influenza ...the ... See full document

... to Medicines by Improving the Predictability of Drug Development and the Regulatory Approval ...1, 2008 Washington, DC. Workshop on Expediting Patients’ Access to Medicines March 30–31, 2009 Surrey, ... See full document

... authorised medicines, the Agency has progressed its collaboration with the European Network for Health Technology Assessment (EUnetHTA), a body representing the HTA bodies from across ...the ... See full document

... of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and the European Medicines ...The Agency receives safety reports ... See full document

... of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and the European Medicines ...The Agency receives safety reports ... See full document

... applications which additionally excludes applications for active pharmaceutical substances which had already been authorised in at least one EU/EEA country, independently of the indication for which they were authorised ... See full document

... Assessment Report in the DCP no longer prevents the issue of disagreement on the grounds of potential serious risk to public health from being referred to the ... See full document

... veterinary medicines for minor uses and minor species regarding quality, safety, including maximum residue limits (MRLs), and efficacy, while ensuring public ...develop medicines for ... See full document

... The Agency has continued its contribution to the promotion of research and development in ...the Agency made a successful start with the SME Office, which provides assistance to small and medium-sized ... See full document

... In collaboration with IFAH-Global, the EMEA hosted a Global Animal Health Conference on 15-16 November 2007. This conference brought together all major stakeholders in animal health, including industry, academia, ... See full document

... The objectives of the sampling and testing programme, derived from the legal requirements, are to supervise the quality of centrally authorised medicinal products placed on the market and to check compliance of these ... See full document

... If food-producing animals are treated with medicines, residues may remain in the food produced by or from them. To obtain a marketing authorisation for a veterinary medicinal product intended for use in a ... See full document

... other medicines containing rosiglitazone, the suspension of the anti-obesity medicine sibutramine, and investigations into the childhood vaccines Rotarix and Rotateq, following the detection of ... See full document

... the Agency devoted most attention in 2009 was the outbreak and rapid global spread of the H1N1 influenza ('swine flu') ...of European citizens – demonstrated to Europe and to the world that the ... See full document

... recommendation calls for the introduction of new innova- tive pricing & reimbursement arrangements. The results of our study indicated that the notion of the cost of therapy was a key consideration during the ... See full document