Drug development and regulation

Abstract 

Models of drug development are moving away from those traditionally represented by large multinational pharmaceutical companies. The reasons for this trend and the likely shape of the pharmaceutical industry of the future are discussed here. The principal targets of the approaches that have delivered the majority of the medicines available today are encompassed by the concept of a ‘receptor’. While this has been a fruitful approach for the past 50 years, the great majority of receptors have now been identified and targeted. Drug discovery is moving into a different phase which will involve a much greater range of potential targets. These new approaches bring their own challenges for drug developers. The impact of these changes on the traditional scheme of drug development is discussed. The UK and EU regulatory framework for the licensing of drugs has changed substantially in recent years. The key concepts and interplay of regulatory bodies and advisory committees is explained. The European Clinical Trials Directive (2001/20/EC) has been implemented in the UK and EU and has implications for every healthcare professional involved in clinical research. The practical impact for the practising physician is outlined.

Keywords: clinical trial, drug development, drug discovery, European Clinical Trials Directive, licensing authority