It takes an average of ten years for a chemical compound to make the journey from the laboratory to reach the pharmacy shelf as a medicine.
This section provides links to information to help you find out more about the life cycle of medicines from their first scientific discovery through to licensing and ongoing monitoring.
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From laboratory to pharmacy shelf 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. This section gives a brief overview of a chemical compound’s journey to reach the pharmacy shelf as a medicine. Drug discovery Drug companies are continually searching for new compounds to develop into acceptably safe and effective medicines. This discovery phase takes several years and requires a wide range of skills and expertise. Pre-clinical research Before a promising compound can be safely tested on people, a great deal more detailed research must be done to answer vital questions about its chemical properties and ability to treat a particular disease or symptom – this is known as pre-clinical research. Clinical trials Clinical trials are the start of the process that ends with a medicine being licensed and used for treatment. They aim to find out if a drug works well in people, has an acceptable level of side effects and is at least as effective as existing treatments. |
Licensing (marketing authorisation) By law, before a medicine can be placed on the market, it must be given a marketing authorisation (product licence) by a medicines regulator. The UK regulator is the MHRA. The MHRA also inspects the factory where the medicine is to be made, to make sure that supplies will be of a uniformly and consistently high standard. Monitoring medicines after licensing Regulators and pharmaceutical companies work together to continuously monitor the safety and quality of medicines after they have been licensed, so that swift and appropriate action can be taken to protect patients, should the need arise. Changes in the use of a medicine The more widely a medicine is prescribed, the more becomes known about its effects, and a change in use may be required – for example an effective medicine could be used more widely or issues could restrict the use of a certain drug. The availability of medicines When licensing a new medicine, the regulators focus on quality, safety, and how well it works. They do not take into account the cost effectiveness or value for money of a medicine, or its impact on NHS budgets. To help them weigh up the health and financial pros and cons of a treatment, independent agencies in each of the UK countries recommend which treatments to use, based on what is known about how well they work and how much they cost to prescribe. |
