The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials. The paper applies to trials conducted outside of the EU and the European Economic Area that are submitted in marketing authorization applications to European regulatory authorities, with the aim of ensuring that all trials, no matter where they’re conducted, meet the required standards.

The framework provided in the paper applies to medicines for humans and enters into force on May 1, 2012.

According to a statement from the EMA, the increasing globalization of pharmaceutical R&D has created a significant challenge for regulators.

“...no matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting,” explains the EMA statement. “Yet regulators, healthcare professionals and patients worldwide all rely on the same trial data when making decisions on whether to allow a medicine on the market or not and on whether to use a medicine or not.”

The reflection paper addresses this challenge by outlining concrete steps for international cooperation in the regulation of clinical trials, with an emphasis on initiatives that will allow for a common approach to the oversight of trials. In addition, the paper will help assure regulators that ethical and GCP standards are applied to trials, both during development and the marketing authorization application phase.

Clinical trials that are conducted outside of the EU and submitted in marketing authorization applications to European regulatory authorities must meet the same ethical principles and standards that are required of trials performed within EU borders. To achieve this, the paper highlights the importance of independent local ethics committees in the oversight of clinical trials, as well as the necessity of obtaining trial participants’ consent.

The reflection paper follows an extensive public consultation, and has been endorsed by the EMA’s Committee for Medicinal Products for Human Use, the Coordination Group for Mutual Recognition and Decentralized Procedures – Human, the management board of the EMA and the Heads of EU Medicines Agencies.

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