EMA Publishes Annual Report

Print 19 May 2016
BioPharm International

The European Medicines Agency (EMA) published its 2015 annual report on May 17, 2016. The report provides information on the agency’s market authorization approvals for the year, gives an update on the agency’s projects, and features interviews with industry representatives on topics such as data requirements and immunotherapies.

According to an EMA press release, 2015 saw the recommendation of 93 drugs, which included 39 new active substances, for market approval. The agency also granted 177 orphan designations, provided 71 positive opinions on pediatric investigation plans, and recommended 31 advanced therapy classifications.

EMA’s objective to collect high quality data from manufacturers appears to be going well. The agency received 510 requests for scientific advice and protocol assistance and 30 applications for parallel scientific advice with health-technology-assessment (HTA) bodies. Approximately half of companies that received positive opinion on their drug had received scientific advice from the agency during the development phase.

Drug safety programs saw a boost in 2015. Product safety information was updated on many medications, and the EudraVigilance adverse drug reaction collection and management system saw more than 1.2 million reports on suspected side effects, with more than 48,000 reports originating from patients in the European Economic Area, which is a 30% increase from 2014. EMA suggests this increase shows that patients are increasingly making use of the opportunity to directly report on side effects they experience.

The annual report highlights EMA’s achievements in regards to projects and initiatives such as the launch of the PRIority MEdicines (PRIME) program, which supports development of treatments for unmet medical needs. EMA also gives an update on programs and legislation to fight antimicrobial resistance and other public health threats, as well as efforts to strengthen safety monitoring.

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