11. Marketing and Post-Marketing Safety Surveillance

The marketing process involves sharing the information about the new medicine with doctors, other health care professionals and patient organisations so that they become aware of the effects of the new medicine, and doctors may prescribe it in cases where they and their patients have evaluated its benefits.

However, the development process does not stop there. There is still a need to collect and analyse the information about the safety of the medicine when it is used in ‘real‑life’ (called pharmacovigilance). This is because:

• In clinical trials (which are designed to give clear answers), patients ideally only have the illness being studied and are not taking any other medicines.
• In real-life, a large number of patients take the new medicine. They may have several other illnesses and take a variety of other medicines.
• Real-life data from large numbers of users also help to discover very rare side effects, which are hard to detect in the highly controlled setting of a clinical trial.

Both the clinical trials and real-life data are necessary to fully understand the real benefit-risk relationship.