gms | German Medical Science

Development costs of medicinal products are continuously increasing and have reached heights of one to two billion dollars for medicines containing new active substances and this is partly due to the high attrition rates in development programs. In order to mitigate this trend of ever increasing expenses, which is also reflected in dramatic rises in health care expenditures, regulatory bodies are offering scientific advice to pharmaceutical developers, based on the idea that an early discussion and agreement on various design aspects may aid in success rates of medicinal product development.

The European Medicines Agency (EMA), through its scientific Committee for Medicinal Products for Human Use (CHMP) and the Committee for Orphan Medicinal Products (COMP), has established a specific working party, the Scientific Advice Working Party (SAWP), which is in charge of providing scientific advice on a centralised European level, in accordance with the European pharmaceutical regulation as laid down in Council Regulation (EC) 726/2004.

The current composition of the SAWP and steps of the scientific advice procedure will be presented together with an overview of various situations in which scientific advice may be particularly recommendable and of several types of procedures that exist apart from the regular standard process. Examples of useful and less useful questions, dos and don’ts will be given and specific challenges and benefits will be addressed.

Finally, principal aspects of EMA scientific advice will be contrasted with scientific advice made available by individual national regulatory agencies.