Life cycle of a medicine
made by Balázs Vály
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Sometimes there will be changes in the use of a medicine, when it is shown to work well in different groups of patients or for different conditions.
Marketing authorization and monitoring
Pre-clinical and clinical stage
- The manufacturers then apply to the regulator for a marketing authorisation (licence) so that the medicine
can be put on the market.
- Once licensed, the effectiveness and safety of the medicine continue to be carefully tracked by the manufacturers, regulators, healthcare professionals, and the public. This monitoring may include further
research, which can be carried out many years after a licence has been granted.
- Promising compounds are then tested in the laboratory and in living tissue in pre-clinical research.
Thousands of compounds never go beyond tis stage.
- Those that do are then tested on gradually increasing numbers of people in phased clinical trials, a stage of development that usually takes around six years.
Who regulates medicines ?
Discovery stage
- The European regulator is the European Medicines Agency (EMEA)
- Whether it’s cough mixture or cancer drugs, all medicinal products have to be licensed-given a marketing authorisation-before they can be put on the market.
- A licence means that a medicine has been thoroughly tested and quality controlled, to make sure that it is acceptably safe and works as intended.
- when a compound is screened for its potential to be developed further and its make-up assessed in detail
- The development of any new medicine requires a great deal of skill
- and expertise and costs millions. Thousands of promising compounds
- never make it out of the laboratory. On average, only one in 5000 will
- end up as a prescription medicine.
Introduction stage
- A medicine starts life as a chemical substance or compound
- This stage of the cycle could be the most expensive for a company launching a new product
- For example at a medicine it takes over 12 years and on average costs over 1 billion euro to do all the research and development necessary before a new medicine is available for patients to use