EC, Europe is unique in being ICH’s only supranational Regulatory Member given that the same regulatory framework on pharmaceuticals is applicable across all the Member States of the European Union ('EU') and the European Economic Area ('EEA'). The European Commission is the executive of the EU. Its main responsibility is to propose legislation, ensure compliance with existing legislation, to develop policy in the European Union and to ensure the Union's external representation. In addition to EU legislation and policy on pharmaceuticals, there are technical and scientific requirements that complement the legislation and policy all of which, taken together, form this common regulatory framework to promote the functioning of the internal market, to allow free movement of pharmaceuticals across the whole EEA and to guarantee a high level of public health protection.

The European Medicines Agency ('EMA') is an Agency of the European Union responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU. In ICH, the EMA is providing the Commission with its technical and scientific support and is coordinating the scientific expertise put at its disposal by the EU Member States, notably through EMA's main scientific committee, the Committee for Medicinal Products for Human Use ('CHMP').

Owing to this common regulatory framework on pharmaceuticals that is applicable in all the Member States of the EU, the European Commission is a Founding Regulatory Member in ICH. For further information please click here.