Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as a critical requirement to the ethical conduct of research involving human subjects.
A key statement underpinning the Clinical Trial Directive is as follows: “The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.”
Note: 1. Directives are translated into National Law in each Member State in the EU 2. Various application routes exist (centralized, mutual recognition, decentralized and national) for Marketing Authorizations. Standards are co-ordinated via the European Medicines (Evaluation) Agency. 3. There are also Regulations issued which bring about legislation immediately. Regulations also approve the use of EU funds for central organizations such as the European Medicines Agency (EMEA)