NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.
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MHRA. My medicine: From laboratory to pharmacy shelf. 26th September 2008
The Medicines and Healthcare Regulatory Agency (MHRA) has launched a new web resource about medicines. It aims to help consumers find out more about the life cycle of medicines, from their first scientific discovery through to licensing and ongoing monitoring.
The web resource explains, in several sections:
- how and why medicines are developed
- how the process is regulated and monitored
- how potential problems can be reported, and
- why not all medicines are widely available in the NHS.
Each section covers a different stage in the life cycle of a medicine, with links to other relevant articles and useful websites where further information is available.
- From laboratory to pharmacy shelf considers which bodies are responsible for regulating medicines, why regulation is needed, and the stages involved in the development of a medicine.
- The drug discovery section looks at why certain medicines are developed and others are not, where they come from and what factors govern further development.
- The importance of pre-clinical research, showing whether the compound has the potential to act like a medicine or not, is highlighted.
- The clinical trials section asks why trials are needed, who takes part and what’s involved? The different types and phases of trials are considered, together with a brief discussion on how quality safeguards are put in place to protect trial participants.
- The licensing (marketing authorisation) section explains howthe regulator weighs up the pros and cons of the medicine and considers whether it is acceptably safe to be marketed.
- The next section looks at monitoring medicines after licensing and the different ways in which problems with medicines, such as side effects, are flagged up.
- The changes in the use of a medicine which can occur once more becomes known about its effects are then outlined.
- In the final section, the agencies responsible for the availability of medicines and the procedures they follow are considered briefly.
There is also a useful glossary of MHRA terms.
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