How cancer medicines are licensed in the UK

Medicines go through a review process after they have been through clinical trials. This ensures they're safe and effective, and that the benefits outweigh possible side effects. The licence will confirm what condition a medicine should be used for and what dose is best.

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) are responsible for licensing medicines.

Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA reviews all new drugs in the UK. They look 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 and international regulations so that they protect public health

At the end of their review, the MHRA will decide whether to authorise the drug. Once a drug has authorisation, it is 'licensed' or 'approved'. All these terms mean the same thing. 

The MHRA works with other medicines regulators in certain countries around the world. 

If a medicine has been approved by another regulator, the MHRA can consider their review and how they made their decision. This makes the MHRA process faster. They may then approve a drug, or they can reject an application if they don’t think there is enough evidence.

In Northern Ireland, medicines are approved by a regulator called the European Medicines Agency (EMA). From January 2025, medicines will be approved by the MHRA.

How long does it take?

It can take many years for new medicines to go through the research, clinical trials and licensing process. Sometimes, doctors can access new drugs that haven’t been licensed yet through the Early Access to Medicines Scheme (EAMS).

The EAMS aims to give people with life threatening or severely debilitating conditions access to medicines. Doctors can use the scheme when no other treatment is available for these conditions.

After a drug is licensed

After getting a licence, other organisations also need to approve the drugs. Only then can doctors prescribe them.

These organisations decide which drugs work well and are cost effective to use. They are:

• The National Institute for Health and Care Excellence (NICE) in England
• The Scottish Medicines Consortium (SMC) in Scotland
• The All Wales Medicine Strategy Group (AWMSG) in Wales

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.

Off label prescribing

A drug is usually licensed to treat a specific: 

• type of illness or cancer
• age group
• dose

Sometimes a doctor might want to use a drug in a way that is 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'.