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DRUG REGULATORY AFFAIRS INTERNATIONAL
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A System of Equivalent Member States, a Coordinating Agency and a Centralized Institution
The regulatory system for supervision of pharmaceutical manufacturers and GMP inspection in the European Union is one of the most advanced in the world. Due to the globalization of pharmaceutical manufacture, it also affects industry, regulators and patients outside the European Union. This system, however, is often poorly understood beyond the EU borders.
What follows is an explanation of the EU system in order to increase awareness and facilitate cooperation on GMP between European Union regulators and those outside the European Union.
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The European Union
The European Union includes 28 Member States located in Europe, which are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and United Kingdom. The EU total population is about 500 million people.
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