Decentralised procedure [DP]

Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths - the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.

Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations and directives. The European Medicines Agency (EMA) coordinates the development of new and revised EU scientific guidelines in working groups/parties.

The medicines development process' ultimate goal is an approval for marketing the new medicinal product – a Marketing Authorisation. This should be an integral part of all steps throughout the life-cycle of the medicinal product. A Marketing Authorisation Application contains information on quality, and non-clinical and clinical studies.

To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or negative opinion. This is to ascertain that the research is conducted in compliance with European regulations, directives and guidelines defined by the International Conference on Harmonisation. This is an international quality standard that describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.