Drug development process

The full drug development process is a lengthy and complicated one taking ten to twelve years. The cost of developing a new drug is over €800 million, about 60% of which is spent on necessary rigorous clinical trials. New drugs are selected from a range of many thousands of substances with the potential to treat the targeted condition. For a variety of reasons, fewer than one or two compounds per ten thousand tested actually make it to the market and are authorised for use in patients.

The file below sets out the different phases in a linear fashion over time. In reality this is becoming a complex and iterative process rather than a simple linear path, and while all the steps outlined below must take place, the sequence and cycles may vary.