Guidance

Guidance note on new assessment routes

New routes for assessment including an accelerated procedure and rolling review

The MHRA has introduced changes to national licensing procedures, including procedures to prioritise access to new medicines that will benefit patients, an accelerated assessment procedure and new routes of evaluation for novel products and biotechnological products.

Pre-submission scientific advice meetings with the MHRA assessment teams at suitable times during the development cycle are encouraged. At the meeting the company may present their intentions, a short summary of the dossier and raise any special issues such as requests for consideration for conditional marketing authorisation (CMA) or marketing authorisation (MA) under exceptional circumstances. Pre-submission meetings offer opportunity to enhance joined up work with the HTA evaluation process.

The services of the MHRA Innovation Office are also available to provide access to world-class expertise within the MHRA regulatory centre, as well as from the Clinical Practice Research Datalink (CPRD) and the National Institute of Biological Standards and Control (NIBSC).

The MHRA Innovation Office is open to all innovation queries - particularly those that challenge the current regulatory framework.

Prioritising Access to New Medicines

The MHRA is working with partner organisations in the UK to develop approaches to reduce the time to patient access for new medicines and technologies that will benefit patients. The key features of the approach will include a new medicine designation that links to the development of a roadmap to patient access in the UK healthcare system.

The roadmap will provide a clear pathway for product development, offering a toolkit of support options and providing a platform for sustained multi-stakeholder interactions. The toolkit is intended to drive efficiencies in the development programme by supporting data generation and advising on evidence requirements.

An integrated pathway will pull together expertise from across the MHRA and partners in the wider healthcare system such as NICE, with multiple entry points available to developers. Further detailed information will be published by December.

Accelerated Assessment Procedure

See information on this procedure in our guidance on 150-day assessment for national applications for medicines.

Guidance on the Rolling Review route

The Rolling Review is a new route for marketing authorisation applications, intended to enhance development of novel medicines. It does this by offering on-going regulatory input and feedback enabling the applicants to ‘get it right first time’ and ensuring that applications can be approved as efficiently as possible. Fees applicable will be published in due course.

Eligibility

Applications for any new active substances including biological products that wish to obtain a marketing authorisation in Great Britain based on submission of a ‘full dossier’ to the MHRA are eligible for a rolling review. Similar biological applications (biosimilar products) are also eligible for rolling review.

Process and sequence

The process is a phased, modular, iterative approach to evaluation of marketing authorisation applications. The quality, non-clinical and clinical modules may be submitted separately or in combination depending on the individual circumstances as data becomes available. It is expected that each module will be near completion to avoid multiple iterations of assessment of the same module.

Each assessment phase will progress independently, and any questions raised will offer the applicant the opportunity and time for a comprehensive update of the modules prior to final submission.

The final phase will involve submission of a complete application including updated versions of the modules evaluated previously.

Compliance with GB paediatric requirements are expected to be addressed prior to the final phase. The final assessment is expected to be a single phase with the decision on approval of the marketing authorisation. The Risk Management Plans (RMP) will also be part of the final evaluation.

Enhanced regulatory interaction and advice will be available during the rolling review process supporting the development process and reducing the risk of delay at the final stage.

Expert input

Consultation with expert advisory groups is anticipated at each stage and with CHM and therapy areas experts prior to grant of the MA. The MHRA will publish further information on the details of the scheme in due course.

Recognition of a European Commission licensing decision for products approved in the community marketing authorisation procedure and recognition of marketing authorisation approval decisions taken by European Union Member States in decentralised and mutual recognition procedures.

For two years from 1 January 2021, Great Britain will adopt decisions taken by the European Commission on the approval of new marketing authorisations in the community marketing authorisation procedure .

Applications should include all information provided to EMA during the licensing procedure and should be accompanied by all iterations of the CHMP assessment report including the final CHMP opinion. A declaration of conformity of the Great Britain application with the dossier approved by the European Commission.

Marketing authorisation applications should be submitted to the MHRA following receipt of the CHMP opinion and will be determined following confirmation of notification of the EC decision.

All UK national requirements apply.

The UK will also have the power to take into account marketing authorisation decisions of EU Member States when considering applications for marketing authorisations for products that have been approved in decentralised or mutual recognition procedures.

Applications should include all information submitted to the reference Member State and accompanied by all iterations of the RMS assessment report, including the RMS end of procedure notification. A declaration of conformity of the UK application with the dossier approved in the RMS should be provided.

The application should be submitted to the MHRA following receipt of the RMS end of procedure notification.

All UK national requirements apply.

Applications will be reviewed for compliance with UK specific requirements.

Guidance on supply of medicines from Northern Ireland to Great Britain under Unfettered Access will be provided in due course

Fees applicable to GB marketing authorisations taking account of an EU decision will be published in due course.

Applications should be submitted through the MHRA portal. See guidance on how to make submissions to the MHRA through the portal.

Contact us

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Published 31 December 2020