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MHRA awarded the first PIM designation for a cell therapy product for the treatment of cancer on 8 September 2014.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
On 7 April 2014 the Early Access to Medicines Scheme was launched.
Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will provide a scientific opinion on the benefit/risk balance of the medicine, based on the data available at the time of the EAMS submission. The opinion lasts for a year and can be renewed.
MHRA has previously consulted on proposals for the scheme. Here is the government response to this consultation.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.
Please note that as the scheme was only launched on 7 April, MHRA may not initially be able to process applications for designation/opinion as quickly as we would like, dependent on the number of applications.
MHRA is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process:
- step I, the promising innovative medicine (PIM) designation
- step II, the early access to medicines scientific opinion.
Step I - Promising innovative medicine (PIM) designation
The PIM designation will give an indication that a product may be eligible for the Early Access to Medicines Scheme (based on early clinical data). The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.
Guidance on applying for a PIM designation is below:
To submit an application, please fill out the form below and send it to firstname.lastname@example.org
Step II - Early access to medicines scientific opinion
The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to MHRA by an applicant after sufficient data have been gathered from the patients who will benefit from the medicine. The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.
If you want to apply for an EAMS scientific opinion from MHRA you must have a PIM designation and attend a pre-submission meeting with the MHRA.
Guidance on applying for a scientific opinion, including the pre-submission meeting is below:
The aim of the pre-submission meeting is to ensure that your product is suitable for an EAMS scientific opinion application and to discuss the format of the data you need to submit to support the opinion. There is no separate fee for the pre-submission meeting.
To apply for a pre-submission meeting please fill out the form below and send it to email@example.com
Apply for an EAMS scientific opinion
Please read the guidance for applicants on the scheme to get more information about the documents you need to submit.
You need to include the following documents, which are part of the EAMS dossier, with your EAMS application submission:
- completed EAMS application form (505Kb)
- cover letter including the proposed timetable submission slot and EAMS number
- summary of the pharmacovigilance system master file (PSMF)
- a risk management plan (RMP) (551Kb)
Please send your completed submission to firstname.lastname@example.org
Following a positive EAMS scientific opinion, MHRA will publish a Public Assessment Report (PAR) and the EAMS treatment protocol on the MHRA website. The PAR will include:
- how the product is used and how it works
- summary of the key clinical studies
- the risks and benefits of the product
- the reason for the positive EAMS scientific opinion
- any uncertainties
- information about ongoing clinical studies
- measures in place to monitor and manage risk.
Dates for submission
You need to make your EAMS scientific opinion submission by one of the dates set out below. The document below gives more information about submission dates:
Submission dates (60Kb)
|Submission dates 2014||Submission dates 2015|
|5 May||5 January|
|2 June||2 February|
|30 June||2 March|
|4 August||30 March|
|1 September||4 May|
|29 September||1 June|
|27 October||29 June|
|1 December||3 August|
Periodic updates and renewals
Once you have received a positive EAMS scientific opinion you must provide MHRA with regular updates. The exact frequency of these updates will be agreed before the scientific opinion is issued but is likely to be every three months. Please use the template below to send periodic updates to MHRA.
The same template should also be used to renew your scientific opinion after a year. Completed forms should be sent to email@example.com
The fee for the PIM designation is £4,027.
The fee for assessment of the scientific opinion for new chemical or biological medicinal products is £29,000 and the renewal fee (if applicable) is £14,500.
The fee for the assessment of the scientific opinion for new indications is £9,232 and the renewal fee (if applicable) is £4,616.