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:
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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:
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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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European Medicines Agency launches consultation on pharmacovigilance changes to product information
The European Medicines Agency has launched a public consultation on the changes to the product information stemming from the new pharmacovigilance legislation. The legislation requires the addition of information to the summary of product characteristics, which is targeted at healthcare professionals, and to the package leaflet, which is targeted at patients and consumers. This information includes:
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European Medicines Agency encourages companies to use electronic application tools
The European Medicines Agency reminds pharmaceutical companies that electronic application formsExternal link icon are available for use. Applicants can use the online forms for all applications for human and veterinary medicines in the centralised procedure. The electronic forms offer a convenient alternative to the paper versions and include the same content with structured data fields implementing controlled terminology lists and catalogues.
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New pharmacovigilance legislation comes into operation
Better protection of public health through strengthened EU system for medicines safety
The European Medicines Agency welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.
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European Medicines Agency finalises update to diabetes guideline
The European Medicines Agency has updated its guidance for pharmaceutical companies developing medicines for the treatment or prevention of diabetes. The guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus, published today, updates the previous document from 2002. It gives guidance on the clinical studies required to support the authorisation of new medicines for treating or preventing diabetes.
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