My medicine: From laboratory to pharmacy shelf

The pages set out to explain:

• How and why medicines are developed
• How the process is regulated and monitored
• How potential problems can be reported and what you can do to help
• Why not all medicines are widely available in the NHS.

Each one covers a different stage in the life cycle of a medicine, with links to other relevant articles in the series and useful websites where you can obtain further information.

You may also find this glossary of terms helpful:

Glossary of MHRA terms

An overview of each of the pages is available below. Each page is also available in pdf format, should you prefer this format - these documents are available in the 'Featured publications' section at the right of this page and on each of the individual pages. The entire section is also available in pdf format.

Your feedback
We would be very grateful for your feedback on this section so that we can further develop it to meet your needs. Please could you send any comments or suggestions to: webusability@mhra.gsi.gov.uk

 From laboratory to pharmacy shelf

Who regulates medicines?
Which bodies are responsible and why regulation is needed.

What does acceptably safe mean?
The balance between the advantages and disadvantages of a medicine.

The life cycle of a medicine
The stages in development from start to finish.

Who decides which medicines can be prescribed?
Why not every medicine is widely available.

 Drug discovery

Ideas for drug development
Why are certain medicines developed?

The search for a new compound
Where do these come from?

Weeding out unsuitable compounds
What factors govern further development?

 Pre-clinical research

What the research can tell us
Why is this type of research important?

Why are animals still used?
The science behind living tissue research.

 Clinical trials

Why are trials needed?
What’s involved?

Who takes part?
Do you have to be ill first?

Trial phases
Why are different stages needed?

The different types of trial
What purpose do these serve?

Quality safeguards
Who protects patients?

 Licensing (marketing authorisation)

Why is licensing important?
What does the process aim to achieve?

Weighing up the pros and cons of a medicine
What does the regulator need to know?

“Off label” or “unlicensed prescribing”
When is this used, and why?

The role of the European regulator
Where does this fit in?

 Monitoring medicines after licensing

Who is involved?
The different routes for flagging up problems.

What action is taken?
How is the alarm raised?

New medicines “on probation”
How the Black Triangle Symbol works.

Using research to check on safety
The General Practice Research Database.

What to do about side effects associated with a medicine
Reporting problems

Tackling fake (counterfeit) medicines
How can you help to stamp out this growing problem?

 Changes in the use of a medicine

What changes can be made?
When is access restricted or opened up?

Switching the legal status of a medicine
How will this affect you?

Withdrawing a medicine
What happens?

Reporting side effects and symptoms
Using the Yellow Card Scheme to make a difference.

 The availability of medicines

Which agencies are responsible?
The different UK bodies involved.

Which treatments are reviewed?
What’s the agenda?

The principles involved
How is it done?

Putting the recommendations into practice
How the NHS responds.

Special cases
Using medicines not licensed in the UK.