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) looks at applications for new drugs within the European Union (EU).
All new cancer drugs are looked at using a process called the centralised (or community) authorisation procedure. This procedure gives a marketing authorisation (licence) for all EU countries, 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) looks at a new drug when pharmaceutical companies want to license medicines outside of the EMA’s centralised authorisation procedure.
The MHRA also enforces European drug licensing regulations in the UK. And it ensures the safety and effectiveness of medicines in the UK.
The MHRA is responsible for:
- the approval of clinical trials carried out in the UK
- regularly inspecting laboratories and pharmaceutical companies
- sampling 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
After a drug is licensed
A drug is usually licensed to treat a specific type of illness 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'.
Once a drug is licensed, NICE might assess it to see whether it should be widely available on the NHS in England. The Scottish Medicines Consortium (SMC) decides if the new drug should be available on the NHS in Scotland.
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.