Fast tracking of marketing authorisation applications

The criteria and procedures are as follows:

1. Fast tracking of marketing authorisation applications: Major therapeutic breakthrough
The MHRA is prepared to consider fast tracking applications when there are compelling reasons for believing that the product would provide a major breakthrough in the treatment of patients for certain conditions.

Disease categories for which fast tracking of applications may be applicable:

• 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 in a disease with wide-spread resistance to treatment with currently available therapeutic agents:
• The emergence of a new disease entity which has severe or life-threatening effects and for which currently available treatments are ineffective or otherwise inadequate:

If you wish to apply for fast tracking of an application, please write to The Director, Licensing Division, Medicines and Healthcare products Regulatory Agency, Room 11-206, Market Towers.

Your letter should indicate and justify which of the disease categories listed above applies.  A brief description of the major clinical properties of the product together with evidence supporting its claimed benefits in the proposed indication(s) should accompany your letter.  This information should normally be contained in no more than three pages.

Your request will be considered by the MHRA Executive Board and its decision will be communicated to you in confidence.  No extra fee is payable.

2. Fast tracking of marketing authorisation applications: In the event of a shortfall of medicines
The MHRA has instituted a procedure to fast track marketing authorisation applications and importation of unlicensed medicines in the event of a shortage of supply of essential products.

Fast tracking would be considered where there was a scarcity (actual or high probability) of essential medicines, where there was a lack of suitable alternative suppliers or alternative treatments, and in circumstances that had the potential to impact adversely on public health. Implementing these procedures would be expected to minimise any negative impact on public health due to shortage.

For both the above situations, a decision to fast track an application would mean that the assessment of the application is commenced out of turn, ahead of its order in the sequence of submitted applications.

Please note that a decision either to agree or to refuse a request for fast tracking will have no implication for the determination of the application in any respect other than the date of the commencement of its assessment.

You should also note that in the event that a request for fast tracking is agreed to, the documentation accompanying the formal marketing authorisation application should be consistent with legal requirements and guidelines relating to applications for marketing authorisations.

Please contact the MHRA Regulatory Information Service on 0207 084 3400 for request on fast tracking of new drugs and abridged products or by e-mail to RIS.NA@mhra.gsi.gov.uk for further information.

The MHRA can agree to fast tracking applications on the ground of a shortage of supply of essential medicines following discussion with Department of Health to verify that there is a supply problem of the medicine(s) concerned. It is advisable for companies to have early discussions with our DH colleagues regarding supply problems to facilitate our consideration of your request for fast tracking. Please contact Isabelle Izzard at Department of Health on 0207 972 2913 or by e-mail to isabelle.izzard@dh.gsi.gov.uk.

For consideration of fast tracking of importation of unlicensed medicinal products due to shortage of supply, please contact Graham Matthews at the MHRA on 0207 084 2715 or by e-mail to  graham.matthews@mhra.gsi.gov.uk.

The above guidance applies to fast tracking of new marketing authorisation applications. Existing procedures for urgent variation applications related to critical care products or supply issues continue to apply and details and contact can be found at the Variations to licences: Sentinel Special Measures Project section.