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Posted On: 08/19/2020 11:33:25 PM
Post# of 148905
Found this on the UK Gov site........
Fast track your marketing authorisation
Applications can be fast tracked if there is compelling evidence to show that the product would provide a major breakthrough in the treatment of certain conditions. There is no additional fee for fast-tracking applications.
The disease categories for which fast tracking of applications may be applicable are:
chronic, debilitating diseases for which available treatments are ineffective or otherwise inadequate
severe or life-threatening diseases for which available treatments are ineffective or otherwise inadequate
the emergence of a disease with wide-spread resistance to treatment with currently available treatments
the emergence of a new disease entity which has severe or life-threatening effects and for which currently available treatments are ineffective or inadequate
To get your application fast tracked you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk. The letter should include:
the disease category
a brief description of the major clinical properties of the product
evidence supporting the claimed benefits of the product for the proposed indication(s)
MHRA Corporate Executive Team will consider your request for a fast-tracked application and their decision will be communicated to you in confidence.
For more information about fast tracking your marketing authorisation email RIS.NA@mhra.gov.uk or call 020 3080 7400.
Applications can also be fast tracked if there is shortage of supply of essential medicines that has been verified by the Department of Health and Social Care (DHSC). If you want to fast track your application because of a shortage of supply we recommend you discuss this with DHSC by emailing DHSCmedicinesupplyteam@dhsc.gov.uk.
Fast track your marketing authorisation
Applications can be fast tracked if there is compelling evidence to show that the product would provide a major breakthrough in the treatment of certain conditions. There is no additional fee for fast-tracking applications.
The disease categories for which fast tracking of applications may be applicable are:
chronic, debilitating diseases for which available treatments are ineffective or otherwise inadequate
severe or life-threatening diseases for which available treatments are ineffective or otherwise inadequate
the emergence of a disease with wide-spread resistance to treatment with currently available treatments
the emergence of a new disease entity which has severe or life-threatening effects and for which currently available treatments are ineffective or inadequate
To get your application fast tracked you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk. The letter should include:
the disease category
a brief description of the major clinical properties of the product
evidence supporting the claimed benefits of the product for the proposed indication(s)
MHRA Corporate Executive Team will consider your request for a fast-tracked application and their decision will be communicated to you in confidence.
For more information about fast tracking your marketing authorisation email RIS.NA@mhra.gov.uk or call 020 3080 7400.
Applications can also be fast tracked if there is shortage of supply of essential medicines that has been verified by the Department of Health and Social Care (DHSC). If you want to fast track your application because of a shortage of supply we recommend you discuss this with DHSC by emailing DHSCmedicinesupplyteam@dhsc.gov.uk.
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