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The European Union (EU) legal framework for pharmaceuticals is based on the principle that the placing of a medicine on the market is subject to the granting of a marketing authorisation by the competent authorities, aimed at ensuring a high level of protection of public health.

Clinical Pharmacology joins basic and clinical knowledge on the pharmacological properties of drugs, and uses clinical, experimental and epidemiological methods and techniques to decide on the best use of medicines. Because of that, the professional profile of clinical pharmacologists is especially suitable to develop a professional career in a regulatory setting, and in fact many clinical pharmacologists are key players in regulatory decision-making.

The European Medicines Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. Most of the EMA’s scientific evaluation work is carried out by its scientific committees, which are made up of members from European countries, as well as representatives of patient, consumer and healthcare-professional organisations. Many clinical pharmacologists are members or experts to these Committees.

The EACPT recognises and promotes the strategic relevance of the regulatory role of the speciality, and thus supports the networking of clinical pharmacologists with a professional interest in drug regulation in different areas: