EMA Mid-Year Report: Fewer New Non-Orphan Drugs, More GMP Inspections

Regulatory NewsRegulatory News | 08 October 2015 |  By 

The European Medicines Agency's (EMA) mid-year report, detailing the agency's activities through 30 June 2015, reveals that the agency met or was ahead of most metrics covered, despite a decline in the number of new non-orphan drugs and a sharp rise in the number of GMP inspections conducted.

Rating System

EMA uses a four-colored "traffic light" system to rate its workload and performance against its forecast goals. Depending on the result for each indicator, the agency has either maintained or revised its forecast figure to match its expectations for the remainder of the year.

In the system, a blue circle indicates a result of more than 10% above the agency's forecast, green indicates a result within 10% of the forecast, orange indicates a result was off by 10-25% and red indicates results were off by more than 25%.

While these indicators can give a general sense of the EMA's workload and performance, the agency cautions that the system does not paint the whole picture.


In the first half of 2015 EMA saw an increase in the number of requests for scientific and protocol assistance from 2014.

The agency also saw a slight decrease in the number of applications for orphan designation, 120, down from 138 for the same period in 2014.

EMA says it met most of its performance goals for its pre-authorization activities and completing 100% of its scientific procedures within their allotted timeframes. However, the agency notes it received a smaller-than-expected increase in requests for scientific advice and saw fewer applications receiving orphan designation than expected.

Initial Evaluations

For initial evaluations in the first half of 2015, EMA saw an increase from the same period in 2014 in all areas except for new non-orphan medicinal products. The agency was initially expecting to receive 48 applications for new non-orphan medicinal products; however, by the end of June the agency had only received 14, prompting it to revise its forecast to 40.

The agency also met its target of evaluating all applications within their legal timeframes, and met its goal of reviewing new drugs and biosimilars in 205 on average.

Inspections and Compliance

For inspections and compliance, EMA beat or came within striking distance of most of its targets.

While EMA was right on target for good laboratory practice (GLP) and good clinical practice (GCP) inspections, the agency noted a 67% increase in the number of good manufacturing practice (GMP) inspections it carried out over the same period in 2014. Additionally, the agency was on target for all its performance metrics related to inspections and compliance, meeting or besting its goals in each area.

Press and Media

For 2015, EMA has introduced new workload indicators for its involvement with the media and press:

  • requests for interviews and comments by media representatives
  • number of press releases and news items published
  • number of reports, brochures and leaflets produced

EMA missed its expected workload for both the number of requests for interviews and comments by media representatives and the number of press releases/news items. In both cases the agency revised its forecast down, by 33% and 25% respectively.

EMA Mid-Year Report 2015



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