[PDF] Top 20 European Medicines Agency. Summary of the annual report of the European Medicines Agency 2005

... the Agency launched the ‘SME Office’, dedicated to addressing the particular needs of smaller companies, following the entry into force of the new SME Regulation 3 to implement provisions relating to incentives ... 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

... • The CVMP, with the support of its Working Party on Environmental Risk Assessment, continued to provide advice on the implementation of the requirements of the amended veterinary directive regarding environmental risk ... See full document

... paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical ... 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

... the European Union and partner countries include specific annexes relating to medicinal products and good manufacturing ...The Agency is responsible for implementation and operational aspects of these ... See full document

... The Agency's Committee on Herbal Medicinal Products (HMPC), with a view to promote an increasingly harmonised process for licensing and information on herbal substances across the EU, establishes Community herbal ... See full document

... the Agency, followed by an official from the Japanese authorities in November ...The European Medicines Agency appointed a staff member as a liaison officer to the FDA in July ...The ... 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 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 European patients die and some 11–19% of survivors suffer life-long consequences, including permanent brain damage, learning disabilities and hearing ... See full document

... September 2005, has added a new dimension to how the Board operates, and their experience and expertise has made an invaluable contribution to the Board’s ... See full document

... − Promoting access to vaccines against the major epizootic diseases of domestic livestock has remained a high priority for the Agency, in particular with respect to avian influenza and bluetongue. Bluetongue is an ... 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

... 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

... Under this procedure, there is a case-by-case decision on whether the handling of safety concerns for a medicine, both pre- and post-authorisation, requires additional scientific input. The CHMP can request the ... See full document

... The majority of positive CHMP opinions adopted in 2008 related to cancer medicines, followed by anti- infectives and medicines for the treatment of neurological and central-nervous-system conditions. One ... See full document

... the Agency, of applications concerning new indications for approved medicines; publication of the names of companies that have been assigned SME status by the Agency; extension of the policy on ... See full document

... medicines developed by pharmaceutical companies for use in the EU. The EMA was set up to ensure the best use of scientific resources across Europe. Experts participate in the work of the EMA as members of its ... See full document