In the interests of safety, and of all concerned in the use of medicines, pharmaceuticals, vaccines, and medical devices, the world of medical therapies is highly regulated.
Before a new therapy can be introduced onto the market it must undergo stringent clinical trials, as part of a controlled process of clinical development. Plans for the development, instructions on procedures, contingencies, results, observations, and conclusions must all be documented. In the pharmaceutical trade, such documents are often referred to simply as ‘regulatory documentation’.
Once a new medicine is approved, doctors, health practitioners and patients need to be made aware of it, when and how to use it, its benefits, precautions, and the known risks – in a range of documents loosely called ‘medical communications’.
The sponsors of new medicinal products are the ones formally responsible for producing all the stipulated documentation, but the task itself, called ‘medical writing’ falls to specialist ‘medical writers’.