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European Commission invites feedback on experience with the paediatric regulation

The European Commission has launched a public consultation on the experience gained with the paediatric regulation. Until 28 November 2012 all interested citizens and public and private organizations are invited to send their contribution to this consultation to the European Commission. The consultation builds on the European Medicines Agency's 'Five-year Report to the European CommissionExternal link icon', which reflects on the experience acquired as a result of the application of the Paediatric Regulation.

European Medicines Agency seeking participants for website user-experience research

The European Medicines Agency is seeking volunteers from the pharmaceutical industry to help develop its strategy for the future development of its websites, particularly: regulatory-affairs or regulatory-intelligence staff responsible for either innovative or generic medicines (human or veterinary); pharmacovigilance professionals (human or veterinary); maximum-residue-limit applicants; clinical-trial sponsors.

Over 1000 SMEs now registered with European Medicines Agency SME office

For the first time since the launch of its SME initiative in December 2005, there are now more than 1000 micro, small and medium-sized enterprises (SMEs) registered with the European Medicines Agency. Companies registered as SMEs with the Agency have access to a number of incentives, including regulatory assistance from the SME office, and reduced fees for certain Agency procedures such as scientific advice and inspections. The Agency recognises the fact that SMEs are a major driver of innovation in the pharmaceutical industry.

European Medicines Agency seeks views on involvement of children and young people in Paediatric Committee

The European Medicines Agency has launched a public consultation on its concept paper on the involvement of children and young people at the Paediatric Committee. The paper describes the Agency's plans to develop a framework of interaction describing how the views of children and young people can be consulted as part of the Committee's work. This framework should:

European Medicines Agency starts consultation on inventory of needs for children's medicines

The European Medicines Agency has begun its first public consultation on its inventory of paediatric medicines. This inventory, which is being developed by the Agency's Paediatric Committee (PDCO), sets out areas where further research and development into medicines for children are needed. It aims to enable:

European Medicines Agency phasing out follow-up measures

The European Medicines Agency reminds marketing-authorisation holders that it is phasing out follow-up measures to marketing authorisations. In the context of an exercise on quality of opinions started together with the European Commission, the Agency and its Committee for Medicinal Products for Human Use (CHMP) have started to classify all post-authorisation measures for human medicines as one of the following:

Electronic application forms fully available for use

The European Medicines Agency is recommending that marketing-authorisation applicants and holders use electronic application formsExternal link icon, following the successful completion of the pilot phase. The electronic application forms allow pharmaceutical companies to apply for initial marketing authorisations, variations or renewals for human and veterinary medicines using interactive PDF forms. Their benefits include:

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