EUROPEAN UNION DECISION-MAKING

The Council of the European Union subsequently adopted the Regulation on 18 December 2006, formally completing the decision-making process. 

The Council of Ministers. The Council is the main decision-making body of the European Union. The ministers of the member states meet within the Council, and depending on the issue on the agenda, each country will be represented by the minister responsible for that subject (foreign affairs, finance, social affairs, transport, agriculture, etc.). The presidency of the Council is held for six months by each member state on a rotational basis. 

J. Peterson and E. Bomberg, Decision-Making in the European Union, Macmillan, London, UK, 1999. 

B. Ballantine, Enhancing the Role of Science in the Decision-Making of the European Union, The European Policy Centre, Brussels, Belgium, 2005, p.3. 

Six parties to ICH represent the regulatory bodies and research-based industry in the three regions, Europe, Japan, and the United States, where the vast majority of new medicines are currently developed. These Six Parties are directly involved in the decision making process and were selected as they represent the regulatory bodies and the research-based industry in the European Union, Japan, and the United States. However, the Conference, its preparations, and follow-up activities are conducted in an open and transparent manner and the presence of observers from other regulatory authorities and WHO is welcomed as a means of ensuring that the benefits of progress towards harmonization can be utilized worldwide. The Six Parties are as follows ... 

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