Drugs go through a process to make sure they’re safe, effective and that the benefits outweigh possible side effects.
In the UK, drugs are licensed through the:
- European Medicines Agency (EMA) for a Europe wide licence, under laws set by the European Commission
- Medicines and Healthcare products Regulatory Agency (MHRA) for a UK licence
The European Medicines Agency (EMA)
The European Medicines Agency (EMA) is responsible for assessing applications for drug licences within the European Union (EU).
New cancer drugs in the EU are licensed through the EMA, using a process called the centralised (or community) authorisation procedure.
This procedure is compulsory for new cancer drugs and gives a marketing authorisation (licence) for all EU member states, plus Iceland, Liechtenstein and Norway.
Once a drug has EU marketing authorisation, it is ‘licensed’, ‘registered’ or ‘approved’. All these terms mean the same thing.
The Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) is the responsible authority when drug manufacturing companies (pharmaceutical companies) want to license medicines outside of the EMA’s centralised procedure.
The MHRA also enforces European drug licensing regulations in the UK. It has several areas of responsibility to ensure the safety and effectiveness of medicines in the UK.
- regular inspections of laboratories and pharmaceutical companies
- routine sampling of medicines to ensure they meet quality standards
- collecting and reviewing evidence about drug side effects from patients and health care workers
- gathering information about fake medicines
- looking at trends in healthcare
After a drug is licensed
A drug is usually licensed to treat a specific type of disease or cancer.
Sometimes a doctor might feel that a particular drug could help a patient with a condition not included in the drug licence. In this case they can prescribe that drug for the patient. But the doctor has to take full responsibility for the outcome. This is called 'off label prescribing'.
Many clinical trials for cancer use medicines 'off label' in this way. The trials want to find out whether drugs licensed for a particular type of cancer could help to treat other types of cancer.
Once a drug is licensed, NICE might assess it to see whether it should be widely available on the NHS.
After licensing, the MHRA continues to collect information about how well the drug works and about the side effects. So they continue to monitor the safety and effectiveness of the drug.