The manufacturer then applies to the MHRA for what is known as a promising innovative medicine (PIM) designation. To be awarded a PIM for a new drug, the manufacturer needs to submit the results from all the research carried out so far on the drug to the MHRA. A PIM is an early signal that the drug may be a possible choice for EAMS, and might be able to help people who have no other treatment options.
2. EAMS scientific opinion
If the MHRA decides that doctors can prescribe the drug, the next stage is a scientific opinion. The manufacturer must have a PIM before they can apply for an EAMS scientific opinion. The scientific opinion describes the risks and benefits of the drug based on data gathered from the patients who will benefit from the medicine. The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved. A positive scientific opinion lasts for a year. The company can then apply to renew it.
3. Public assessment report (PAR)
Following a positive EAMS scientific opinion, the MHRA produces a public assessment report (PAR). This has information about
- How the product is used and how it works
- Summary of key clinical studies/trials (research)
- Which conditions it can be used to treat, such as a particular type and stage of cancer
- Who can give the medicine
- The reason for the positive EAMS decision by the MHRA
- Any uncertainties about the use of the medicine for this condition
- Possible benefits and side effects
- Information about any on-going studies/clinical trials
- How the MHRA will monitor and manage any risks
The PAR is used by the doctor and the patient to decide if the treatment will benefit the patient.
EAMS safety measures
Because the drugs in EAMS are all new drugs, doctors are still investigating how effective the drugs are and what side effects they cause. There may be some side effects that are not yet known about and haven’t been seen in the clinical trials conducted so far.
Doctors need to monitor side effects and how well the drug works while a drug is in EAMS. The manufacturer needs to provide regular updates to the MHRA as part of their agreement to supply the medicine. These updates are given every 3 months, at least.
1. Reporting side effects
To enable the manufacturer to provide these updates, you need to keep your doctor informed of any side effects and/or test results. If you have any serious side effects, you need to let your doctor, nurse or pharmacist know as soon as they happen. Your doctor needs to report all serious side effects to the manufacturer within 24 hours of them happening. All other side effects and test results need to be reported within 5 days.
2. Patient alert card
The patient alert card holds information about the drug you are taking and its known side effects. It also has the contact details for your doctor and specialist nurse. This should be carried with you at all times.
To get access to a drug that is in the EAMS, please talk to your doctor to see if the drug is suitable for your situation. If your doctor agrees that you might benefit from the EAMS drug, he/she will make an application to the Department of Health (DH) in your local area.
If you are not able to access an EAMS drug, it can be very disappointing. Please talk to your doctor about how you are feeling and why you are not able to have the drug. You could also talk to your doctor about taking part in a clinical trial for a new kidney cancer drug: please see our KCSN Clinical Trials Database for lists of kidney cancer clinical trials, and our Clinical Trials Hub for information about taking part in a clinical trial, including patient stories, videos and clinical trial regulations.
Please contact us for more information about EAMS.