Drugs go through a review process. This ensures they're safe, effective, and that the benefits outweigh possible side effects.
In the UK, two agencies license drugs. They are the:
- European Medicines Agency (EMA) for a Europe-wide licence, under the European Commission laws
- Medicines and Healthcare Products Regulatory Agency (MHRA) for a UK licence
The European Medicines Agency (EMA)
The EMA looks at applications for new drugs within the European Union (EU).
They look at all new cancer drugs. They use a process called the centralised (or community) authorisation procedure. This procedure gives a drug marketing authorisation (a licence). It includes 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 EMA also check on the safety of medicines for as long as doctors prescribe them. And they provide information on drugs to healthcare professionals and patients.
The Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA looks at new drugs 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 looks at:
- the safety and quality standards of medicines, medical equipment and blood products
- the safety of the supply chain for medicines, medical equipment and blood products
- promoting international standards to ensure biological medicines are effective and safe
- educating the public and healthcare professionals about the risks and benefits of medicines, medical equipment and blood products
- supporting research and development that benefit public health
- influencing UK, EU and international regulations so that they protect public health
After a drug is licensed
A drug is usually licensed to treat a specific type of illness or cancer.
Sometimes a doctor might want to use a drug for a condition not included in the drug's licence. This happens when they think it might help a patient for a specific reason. 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 available on the NHS in England. The Scottish Medicines Consortium (SMC) decides on new drugs for NHS Scotland.
After licensing, the MHRA continues to collect information. This information is about how well the drug works and about the side effects. So they continue to check the safety and effectiveness of the drug.