How are cancer drugs licensed in the UK?
Cancer drugs, like other drugs, go through a process to make sure that they are safe, effective and that the benefits outweigh the possible side effects. This page tells you about the licensing process for cancer drugs used in the UK. There is information below on
- Who licenses drugs in the UK
- The European Medicines Agency (EMA)
- The Medicines and Healthcare products Regulatory Agency (MHRA)
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
Below there are explanations of what these two agencies do.
The European Medicines Agency (EMA) is responsible for assessing applications for drug licenses 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) 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. These include
- 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
A drug is usually licensed to treat a specific type of disease or cancer. If doctors feel that a particular drug may help a patient with a condition not included in the drug license 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 it may be assessed to see whether it should be widely available on the NHS. There is information about this on our page about what is NICE and what does it do?
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. You can tell the MHRA about any side effects or safety concerns by filling in a yellow card report on the MHRA website at www.mhra.gov.uk/Safetyinformation.
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