All new medical treatments, drugs and devices need to be vigorously tested to ensure they are safe and effective for treating medical conditions and diseases in humans. Treatments are tested both in the laboratory and in the clinic. Laboratory tests are done to ensure they are safe for human use. They are then tested in the clinic in medical research studies involving people; they are called clinical trials.
Pharmaceutical companies use the data collected during laboratory testing and clinical trials to form a product license application. This application is submitted to the regulatory authority in each individual country to obtain a license to market and sell the drug. In general, it can take 10-15 years to complete the tests on new medicines and for the medicine to get to the market place.