[PDF] Top 20 European Medicines Agency. Annual report of the European Medicines Agency 2007

... Initial evaluation covers activities relating to the processing of applications for medicinal products (orphan, non-orphan, similar biological (biosimilar), generic, etc.) from pre-submission discussion with future ... 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

... the Agency currently stands and making preparations for the future. A report on the evaluation of the Agency, carried out by Ernst & Young, was published at the beginning of the ...The ... See full document

... Expediting Patients’ Access to Medicines by Improving the Predictability of Drug Development and the Regulatory Approval Process. Workshop on Predictable Outcomes September 30–October 1, 2008 Washington, DC. ... 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

... the European Medicines Agency, and the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks ...The report recommended that surveillance activities be ... See full document

... a report on the evaluation of the European Medicines Agency and the European medicines network as a ...the European Commission. The report shows that the ... See full document

... The Agency issues plasma master file (PMF) and vaccine antigen master file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community ...The Agency PMF/VAMF ... See full document

... of medicines move increasingly beyond the traditional spheres of Europe and North America, regulators are becoming more keenly aware of the need for international cooperation on ensuring that safe and ethical ... See full document

... The guide will provide comprehensive information on risks to the unborn child due to in utero exposure to valproate, the details of the PPP and the required actions in case of pregnancy or intention to become pregnant. ... 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

... 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

... 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

... The EMEA PAT team continued to meet to review the implications of PAT with a view to ensuring that the European regulatory framework and the authorities are prepared to conduct thorough and effective evaluations ... 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

... 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

... introduction of new procedures and creation of a new scientific committee dedicated to implementing the EU’s Paediatric Regulation, which came into force on 26 January 2007. With the foundation of this new ... See full document

... veterinary medicines, the Agency is responsible for all medicinal products derived from biotechnology or intended primarily for use as performance enhancers to promote growth of or to increase yield from ... See full document

... human medicines intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative disorders and for all designated orphan medicines intended for the treatment of rare ...veterinary ... 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