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Regulatory News | 17 May 2016 | By Michael Mezher
The European Medicines Agency (EMA) on Tuesday released its Annual Report 2015 touting its performance and key achievements for the year.
According to Sir Kent Woods, former chair of the EMA Management Board, 2015 was a year of transition for the agency. In November 2014, EMA Executive Director Guido Rasi's appointment was annulled, leaving the agency without a head until November of the following year when Rasi was re-appointed.
Despite the disruption to EMA's leadership, Kent says the agency was still able to deliver on its work programs and is "well placed" to meet the goals established in its first five-year plan co-developed with the Heads of Medicines Agencies (HMA).
"I am confident that this joint effort sets the European medicines regulatory network on the right course for the coming five years to keep pace with a rapidly changing environment," Rasi says.
In 2015, EMA recommended a total of 93 new drugs and biologics for human use, 39 of which were for new active substances, a 13% increase from the previous year.
Nearly one-fifth of the new active substances EMA recommended in 2015 benefited from one of EMA's pathways to get products to market more quickly. In 2015, EMA says it recommended five products with accelerated assessment, three products for conditional marketing authorization and three products for approval under exceptional circumstances.
However, in contrast to EMA, the US Food and Drug Administration (FDA) approves a far greater rate of products via expedited pathways. In 2015, more than half (53%) of new drugs approved by FDA were given a six-month priority review.
In 2015, EMA granted 177 orphan designations, down slightly from the record 196 it granted in 2014. Additionally, the agency granted 31 advanced therapy designations and issued 71 positive opinions for pediatric investigation plans in 2015.
According to EMA, its scientific advice was instrumental to the development of many of these products. The agency says that roughly half of the products it recommended for approval received scientific advice, with 85% of all new active substances receiving scientific advice.
Overall, EMA says it received 510 requests for either scientific advice or protocol assistance from companies. While this number is down from the 551 the agency received in 2014, a greater proportion of the requests was for scientific advice than in previous years. Additionally, interest it EMA's pilot for parallel scientific and health technology assessment (HTA) advice was three times higher in 2015 than in 2014, with 30 requests for parallel advice compared to only 11 the previous year.
In recent years, Rasi says, "EMA has encouraged medicine developers to seek advice early in the development of a medicine when changes can be made more easily and at a lower cost compared to later stages."
Rasi says that this has been successful for EMA, as the agency is seeing a continued trend toward companies requesting advice early in the drug development process, with 46% of all requests for scientific advice pertaining to questions in early phases of clinical development (Phase I and Phase II).
EMA says it also saw the highest number of requests for scientific advice and protocol assistance from small- and medium-sized companies in 2015, which accounted for 160 of the 510 of the requests the agency received.
Tags: Guido Rasi, Sir Kent Woods, New active substances, Scientific Advice