| Sarah Powell of Liquent argues that when it comes to regulatory information, integration and standardisation are critical
The formation of the EU created a system for inter-governmental co-operation among the member states. As of 1st January 2007, the EU consists of 27 member states and continues to grow. In addition to the EU member states, three European free trade agreement states (Iceland, Liechtenstein and Norway), make up the European Economic Area (EEA, see Figure 1). This intergovernmental co-operation provided opportunities to harmonise requirements for pharmaceutical registration and share of information between regulatory authorities.
The pharmaceutical industry began to see the benefits of intergovernmental co-operation with the formation of the European Medicines Evaluation Agency (EMEA) and introduction of the centralised and mutual recognition procedures in 1995. In 2004, the first part of the new EU pharmaceutical legislation, Title IV of Regulation (EC) 726/2004, was introduced, affecting the biggest change in the structure and roles of the EMEA since its creation. The new EU pharmaceutical legislation comprises (1):
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31st March 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
- Directive 2004/27/EC of the European Parliament and of the Council of 31st March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
- Directive 2004/24/EC of the European Parliament and the Council of 31st March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
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