Resources for Federal Financial Institutions Examination Council (FFIEC)

The Effect of Quality Management on Compliance with European Union GMP Standards

www.mastercontrol.com

How crucial is Europe to the global pharmaceutical market? First consider that Europe, North America, and Japan comprise 80 percent of the world's pharmaceutical market. Take that statistic in conjunction with the estimation from Report Buyer, a renowned market research firm, that the Western European market alone is expected to grow to $245.3 billion by 2012.

The engine that drives the European pharmaceutical market machine is, without question, the European Union (EU). With 27 member states, the EU represents the bulk of the European market. The 10 individual European markets that joined the EU in 2004 continue to show strong growth and contribute to the EU pharmaceutical market's overall strength. Pharmaceutical companies searching for further success in Europe or those wanting to capitalize on these strong growth trends by entering the European market for the first time must efficiently and cost-effectively obtain and maintain marketing authorization (MA).

While individual member states may have different regulation criteria for the sale of medicines in their jurisdictions, they all adhere to the quality management principles set forth in the European Union's Good Manufacturing Practice (GMP) standards. Marketing authorization and subsequent success in the EU pharmaceutical market is therefore contingent upon the effectiveness of a company's quality management systems.

View the Resource

Share or bookmarklet this web page at: