(AGENPARL) - Roma, 20 Giugno 2022(AGENPARL) – LONDON lun 20 giugno 2022
Overview
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.
Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made.
The opinion lasts for a year and can be renewed.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.
The scientific opinion will be provided after a 2-step evaluation process:
- the promising innovative medicine (PIM) designation
- the early access to medicines scientific opinion
See the number of applications made to the early access to medicines scheme for the promising innovative medicine (PIM) designation and the scientific opinion for more information.
Promising innovative medicine (PIM) designation
The PIM designation will give an indication that a product may be eligible for the EAMS 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.
See .
Scientific opinion
The scientific opinion describes the risks and benefits of the medicine 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.
View , including the pre-submission meeting.
Pre-submission meeting
If you want to apply for an EAMS scientific opinion from MHRA you must have a PIM designation. You should also attend a pre-submission meeting with MHRA to:
- ensure that your product is suitable for an EAMS scientific opinion application
- discuss the format of the data you need to submit to support the opinion
To apply for a pre-submission meeting fill out the and send it to <a
Apply for a scientific opinion
To apply for a scientific opinion you should include the following documents, which are part of the EAMS dossier:
- a completed
- a covering letter including the proposed submission slot and EAMS number
- summary of the pharmacovigilance system master file (PSMF)
- If the applicant does not have a marketing authorisation for the proposed EAMS medicinal product in the UK then please use the
- If there is an RMP approved for the product in an authorised indication in the UK that is relevant to the use through the EAMS there is the option to use the .
Please also refer to the guidance text in the EAMS RMP templates themselves for advice on use of the appropriate template.
Send your completed submission to <a
EAMS public assessment report (PAR)
Following a positive EAMS scientific opinion, MHRA will publish a public assessment report (PAR) and the EAMS treatment protocol on GOV.UK. 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, Day 1 and Day 45
You need to make your EAMS scientific opinion submission by one of the dates below:
| Submission date | Day 1 | Day 45 |
|---|---|---|
| 18 July 2022 | 25 July 2022 | 07 September 2022 |
| 15 August 2022 | 22 August 2022 | 05 October 2022 |
| 12 September 2022 | 19 September 2022 | 02 November 2022 |
| 10 October 2022 | 17 October 2022 | 30 November 2022 |
| 31 October 2022 | 07 November 2022 | 21 December 2022 |
| 13 December 2022 | 20 December 2022 | 02 February 2023 |
| 09 January 2023 | 16 January 2023 | 01 March 2023 |
| 06 February 2023 | 13 February 2023 | 29 March 2023 |
| 13 March 2023 | 20 March 2023 | 03 May 2023 |
| 10 April 2023 | 17 April 2023 | 31 May 2023 |
| 15 May 2023 | 22 May 2023 | 05 July 2023 |
| 12 June 2023 | 19 June 2023 | 02 August 2023 |
| 10 July 2023 | 17 July 2023 | 30 August 2023 |
| 14 August 2023 | 21 August 2023 | 04 October 2023 |
| 11 September 2023 | 18 September 2023 | 01 November 2023 |
| 09 October 2023 | 16 October 2023 | 29 November 2023 |
| 06 November 2023 | 13 November 2023 | 27 December 2023 |
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 3 months.
Use the and email it to <a to send periodic updates to MHRA.
The same template should also be used to renew your scientific opinion after a year.
Fees
The fee for the PIM designation is £3,624.
The fee for assessment of the scientific opinion for new chemical or biological medicinal products is £25,643 and the renewal fee (if applicable) is £12,821.
The fee for the assessment of the scientific opinion for new indications is £8,309 and the renewal fee (if applicable) is £4,154.
The fee is not refundable if your application is not successful.
Positive scientific opinions
View current scientific opinions, including public assessment reports and EAMS treatment protocols.
View expired scientific opinions.
EAMS applications: pending, refused, granted
View the number of EAMS applications pending, refused and granted.
EAMS task group and principles guidance
0https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375411/periodic_report-renewal_template.doc’>https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375411/periodic_report-renewal_template.doc
Fonte/Source: https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams
