FDANews
FDAnews Drug Daily Bulletin

EU Regulators Analyze Origins of EMA-Approved Drugs

Feb. 3, 2014

Although most new medicines receiving marketing authorization in the EU come from large and medium-sized pharmaceutical companies, smaller firms and other institutions are an important source of innovation, a new report written by five European Medicines Agency officials says.

The paper, published in Nature Reviews Drug Discovery Friday, identifies all medicines containing a new active substance recommended for marketing authorization by the Committee for Medicinal Products for Human Use between 2010 and 2012 and notes their origins.

Significant findings were:

  • 49 percent of the drugs came from large or medium-sized pharmaceutical companies;
  • 27 percent came from small drugmakers, even though such organizations only account for 13 percent of marketing authorization holders;
  • 17 percent came from universities, public bodies and public-private partnerships;
  • Private-private collaborations accounted for seven percent; and
  • 19 percent of applications for marketing authorization were for orphan drugs and 61 percent of orphan drugs came from SMEs.

Forty-five percent of drugmakers were North American, the paper says, while 37 percent are European and 8 percent are from Japan, China, Israel and Australia. The EU already has a program to support SMEs, the paper says, recommending new incentives for engagement with academics. — Lena Freund

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.