The pharmaceutical sector is extensively regulated by the European Union in the dual interest of protecting public health while completing the single market for pharmaceuticals.
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The European Union aims at completing the single market in pharmaceuticals and fostering a stable and predictable environment for pharmaceutical innovation. The main responsibilities of the European Union are:
to support pharmaceutical innovation in the EU;
to facilitate the market access of new medicines; and
to meet the health needs of European citizens.
International cooperation
Main tasks of the EU:
to promote international harmonisation within the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH), and the International Conference on Harmonisation of technical requirements for registration of veterinary medicinal products (VICH);
to negotiate and apply mutual recognition agreements with third countries;
to establish bilateral dialogues with third countries, including cooperation between regulators through confidentiality arrangements; and
to cooperate with European and international organisations to address issues related to medicinal products.
Source: European Commission
