EMA – TEDDY – European Network of Excellence for Paediatric Clinical Research

Publication: Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen

The Article “Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen” has been published on-line in Orphanet Journal of Rare Diseases 2017. The publication reports the results obtained by EuOrphan database analysis aimed to evaluate the status of orphan drugs

August 7th, 2017|

Brexit: European Medicines Agency (EMA) has to leave the UK

As a consequence of the withdrawal from the European Union (EU), UK will become a third country by March 2019 at the latest. The European Medicines Agency (EMA) is, therefore, working to relocate its Agency from London to one of the other 27 Member States and to ensure a proper functioning of the single market

August 7th, 2017|

EMA: Information guide for healthcare professionals on biosimilar medicines now available!

On May 5th, 2017, the European Medicines Agency (EMA) and the European Commission have published the first information guide for healthcare professionals on biosimilar medicines. This drug category refers to biological medicines highly similar in terms of safety, quality and efficacy to a biological medicine (the “reference medicine”) that has already been authorized. Biological medicines

August 7th, 2017|

EMA 2016 annual report published

The European Medicines Agency’s (EMA) published the 2016 annual report describing its work and impact in the area of medicines and health during last year. The report highlights the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real

August 7th, 2017|

Save the date – Second paediatric strategy forum, London, 13-14 November, 2017

The Second paediatric strategy forum, Medicinal Product Development for Mature B cell Malignancies in Children, jointly organised by ACCELERATE and the European Medicines Agency (EMA), will be held in London at the EMA premises on 13 and 14 November, 2017. The event will focus on mature B cell malignancies (lymphoma and leukaemia) in children and is aimed

June 14th, 2017|