Generic and hybrid applications 60% higher than estimates

Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines — 60% higher than the agency’s forecast. The statistics come from the EMA’s 2009 annual report, which provides a detailed overview of the EMA’s activities during the year.

Despite the increase of generic and hybrid products, however, the overall number of marketing authorizations received by the EMA dropped to 96 — a decrease of 7% compared with 2008. Excluding multiple applications, there were 63 applications by active substance; this time a 16% decrease compared with 2008. Considering the unprecedented generics applications, the statistics highlight a marked drop in innovative medicines.

Although the report and its statistics paint a bleak image for innovator pharmaceutical manufacturers, it’s a different story for the EMA, which has had a very successful year. According to the report, the EMA adopted 125 opinions in 2009 for marketing authorization applications for human medicines — the highest number ever adopted in one year. Assessment times were also considerably lower than in previous years, which the EMA attributed to the high number of generic applications.

The EMA also saw a “substantial” increase in many of its core activities in 2009, including scientific advice requests, orphan designations, variations and safety-related activities, and also made progress on other initiatives, such as the European medicines network — a partnership between the EMA, the EC and more than 40 European medicines regulatory authorities.

H1N1 helps unite global regulators

One of the most intensive events for the EMA in 2009, which saw the agency devoting significant resources to, was the H1N1 influenza pandemic. However, the EMA also believes that it handled the situation well. Chair of the EMA Management Board, Pat O’Mahony, described the EMA’s response to the pandemic as “probably the most striking illustration of the effectiveness of the Agency”. He explained that the EMA’s preplanning enabled a rapid response once the pandemic was declared, as well as the “intensive concentrated scrutiny of product applications leading to the approval of pandemic vaccines”.

O’Mahony also added that the incident demonstrates the importance of inter-agency and international collaborations. According to the report, the pandemic resulted in “unprecedented levels of international cooperation”, with the EMA having regular exchanges with regulators in Australia, Canada, Japan and the US, as well as experts from the World Health Organization.

“The influenza pandemic was by definition a global challenge,” said the report. “The fact that everybody was faced with very similar challenges brought regulators worldwide closer together.”

www.ema.europa.eu