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EMA’s 2012 Annual Report Highlights A Year Of Change And Industry Growth
Highlighting the main trends seen in the activities of the European Medicines Agency, its 2012 annual report summarises some key topics of current interest including gene-therapy and drug regulation.
Released last week, the EMA’s 2012 annual report focuses on how in the last year its attention has been on the use of best evidence in drug regulation, the approval of the first gene-therapy medicinal product and antimicrobial resistance.
From the EMA Executive Director Professor Guido Rasi’s perspective 2012 was characterised by great changes for the EMA set against a backdrop of continuing austerity and increased public scrutiny: “It was a year of change in terms of handling conflicts of interests, in order to tighten the policies in place, and in terms of openness and transparency – two major priorities of the Agency”.
The annual report outlines that the number of initial marketing-authorisation applications (MAAs) received for human medicines had not changed from 2011, at a total of 96 lodged in 2012. In addition it highlights how the Committee for Medicinal Products for Human Use (CHMP), the committee responsible for communicating EMA’s opinions on any queries about human medicines, confirmed nearly 60 positive opinions for the approval of new medicines, which included a positive opinion for Europe’s first gene therapy.
It was noted that there has been a growth in the complexity of the new medicine applications received in 2012. Last year there was an increase by over one third in the number of MAAs for medicines with orphan designation compared with 2011, with 19 applications being processed during 2012.
The EMA welcomes this rise and its significance- that more R&D is going into the rarer syndromes and diseases: “This trend increases the availability of medicines for rare diseases and demonstrates the importance of the orphan-medicines policy”. This is supported by subsequent growth in orphan designations, with 107 designations were granted in 2011 and 148 in 2012, The EMA are anticipating that they will receive more than 150 orphan designation in 2013. “Of note, 72 per cent of the medicines that received a positive opinion for orphan designation concerned medical conditions affecting children”.
Sir Kent Woods, Chair of the Management Board, observes that following market authorisation the EMA’s understanding of the benefit-risk profile of medicines continues to be refined by information gathered in larger and more diverse populations of patients than can be included in clinical trials. “That expansion of knowledge is a joint enterprise of clinicians, industry, patients, academia and regulators”.
The full report can be accessed by clicking here.
Real World Data Europe
Demonstrate the true effectiveness of your drugs to satisfy payers, HTAs and improve patient outcomes