MHRA guidance on operational information sharing for relevant regulatory applications

The UK MHRA has developed a process to share operational information with health system partners across the UK. This applies to medicines applications submitted via National and International Recognition regulatory routes.

For the purposes of operational information sharing, what is the definition of operational information and what information will the MHRA share with health share partners ?

Operational information is defined as administrative information about an application.

The MHRA will share the following operational information:

  • Application details:
    • Applicant,
    • product name (where available),
    • active substance / INN,
    • route of administration and
    • the proposed indication.
  • Application processes:
    • submission date,
    • regulatory route,
    • reference regulator for International Recognition route, and
    • whether the application is for a new MA or a variation for extension of indication.
  • Estimated timelines:
    • the estimated potential MA approval date, and
    • the actual MA grant date, should the medicine be authorised.
What is the purpose of the operational information sharing?

The aim of information sharing with health system partners is to enable the most efficient access of medical products to patients, minimising delays in patient access to newly authorised treatments.

  • In particular, the sharing of this information will facilitate the planning and scheduling of health technology evaluation by Health Technology Assessment (“HTA”) bodies across the United Kingdom to support the publication of timely guidance.
  • It will also enable National Health Service (“NHS”) services across the four UK nations to schedule in any preparatory activities, necessary to proactively manage access arrangements related to the commissioning of new medicines and services for patients.
For which application routes and application types will the MHRA share operational information?

MHRA will provide this information for medicines going through the National route, including

  • Orbis
  • Access consortium
  • GB (non-reliance) products, and
  • through the International Recognition route.

It will provide this information for:

  • a new active substance Marketing Authorisation application or
  • a variation application to extend an indication.

Shared information may be updated over time if it remains within the scope of the above three categories.

Where changes are made to the operational information shared, consent to share this additional information will be sought from the proposed MAH.

What does operational information sharing mean for Marketing Authorisation applicants submitting relevant regulatory applications to the MHRA?

Marketing Authorisation (“MA”) Applicants submitting relevant regulatory applications will be asked to provide consent to share operational information to support timely patient access to medicines.

Where consent from the proposed Marketing Authorisation Holder (“MAH”) has been obtained, operational information for applications for an initial MA or a variation for extension of indication will be shared with health system partners to enable them to plan and execute their operational processes more efficiently.

Is there a start date for operational information sharing?

Operational information sharing became effective on 1 January 2024.

For a proposed Marketing Authorisation Holder, who specifically is responsible for providing consent and how will consent be provided for operation information sharing?

Consent to share operational information for the purposes of operational information sharing must be provided by, or on behalf of, an authorised signatory who is able to provide the assurances required on behalf of the proposed Marketing Authorisation Holder (MAH).

MA Applicants can now consent to operational information about individual applications being shared with health system partners across the UK as part of the online MA application process on MHRA’s Human Medicines Portal.

Can MA applicants provide consent to share operational information following the submission of a relevant regulatory application instead of at the time of submission of a relevant regulatory application?

Yes they can.

MA Applicants who do not consent to share operational information at the point of application submittal may provide consent at a later date contacting partnerships@mhra.gov.uk However, please note that it may not be possible to retrospectively provide consent for all applications undergoing MHRA assessment at this time.

About the operational information sharing once consent has been obtained

Where consent from the proposed MAH has been obtained, information will be shared with health system partners who have made appropriate commitments as to the use and storage of the information.

The commitments include that the information shared will not be used for any other purpose, and will not be used to inform evaluation or procurement / reimbursement decisions made by health system partners.

  • MHRA will share operational information with health system partners on the basis that it is to be treated by them as confidential.
  • The information will be provided to health system partners on the basis that it will only be shared with the necessary staff within the health system partner’s organisations for the stated purpose, including by transfer of the information to the partner’s information systems.
  • All information will be retained by MHRA in accordance with MHRA’s information management processes and policies.
Does consent to share operational information affect any other processes undertaken by the MHRA as part of its regular activities or duties?

No it doesn’t.

Who are the health system partners that the information will be shared with once consent has been obtained?

The following health system partners, from across the United Kingdom, are expected to commit to the underpinning Operational Information Sharing arrangement to access the operational information shared:

  • The National Institute for Health and Care Excellence (NICE)
  • National Health Service England (NHSE)
  • All Wales Therapeutics and Toxicology Centre (AWTTC)
  • NHS Wales Shared Services Partnership (NWSSP) hosted by Velindre NHS Trust
  • Scottish Medicines Consortium (SMC) as part of Healthcare Improvement Scotland (HIS)
  • NHS National Services Scotland (NHS NSS)
  • Scottish Government
  • Welsh Government

Operational information will only be shared with health system partners following their commitment to the underpinning Operational Information Sharing arrangement.

What happens if an applicant does not consent to operational information sharing?

Those who do not consent to share operational information with health system partners may continue to submit applications for licenses and current applications will be unaffected. However, providing partners with an earlier indication of the likely MA timeline will help to mitigate potential delays in patient access.

Is there the scope to withdraw already given consent for operational information sharing for a particular relevant regulatory application ?

Yes there is.

MA Applicants can withdraw consent to share operational information related to a specific application at any time by contacting partnerships@mhra.gov.uk

  • Once notification of consent withdrawal has been received for an application, MHRA will stop sharing the operational information with immediate effect.
  • Any information shared prior to notification of consent withdrawal will remain subject to confidentiality arrangements with health system partners who have committed to the underpinning Operational Information Sharing arrangement.

Source: MHRA