Are you planning to go for approval in the UK? Here is what you need to know

Firstly, the already existing centrally authorised product marketing authorisations (MAs) have been converted into Great Britain (England, Wales, and Scotland) MAs. Existing centrally authorised products remain valid in Northern Ireland.

The assessment time has been reduced from 210 days to a 150-days assessment procedure for national MA applications containing new active substances. This new accelerated assessment route for MAs does what it says, within 150 days after submission of the application, the MHRA is expected to evaluate and reach an opinion.

The rolling review is a new route for MA applications, where data is submitted and reviewed as it becomes available (typically in the order of non-clinical, CMC and clinical data) instead of waiting for the completed data package. The assessment cycle for each submitted module will be completed within 60 days. The final phase is split into two stages, with a clock stop (where required) after 60 days and a decision being reached by day 100.

The Innovative Licencing and Access Pathway (ILAP) is the accelerated strategy in the UK toolbox. The gateway for the ILAP includes the Innovation Passport, which is awarded to pioneering products of new chemical entities, biological medicines, new indications, and repurposed drugs. During the first year of operation, the MHRA received 71 applications and rewarded 41 innovation passports.

The pathway allows entry very early in the development, based on non-clinical data. To speed up the process, ILAP offers companies a rolling review.

Applying for ILAP at an early stage provides opportunities for enhanced input both from MHRA and HTA bodies. The permanent partners in the ILAP are The All Wales Therapeutics and Toxicology Centre, the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC). This early interaction ensures that optimal data is generated for regulatory approval and to support favourable reimbursement outcomes.

The UK has also joined two, somewhat overlapping, international regulatory alliances to expedite the approval of new drugs. The Access Consortium and Project Orbis are both coalitions of 'like-minded' regulatory authorities, aiming not only to speed up the assessment and review process but also to limit the burden of duplicate work for the agencies.  

Project Orbis is an initiative of the FDA Oncology Center of Excellence (OCE) and provides a framework for concurrent submission and review of oncology products.

Involved regulatory authorities besides the UK as of Jan 2021

• Food and Drug Administration, US
• Therapeutic Goods Administration, Australia
• Health Canada, Canada
• Health Sciences Authority, Singapore
• Swissmedic, Switzerland
• ANVISA, Brazil

Three major factors allow national decisions to be expedited through Project Orbis: the initial FDA review, access to the same data and the opportunities to interact directly with the review team.

While FDA serves as the primary coordinator for application selection and review, each participating country remains fully independent on their final regulatory decision. The first result of Project Orbis was the MHRA's approval of a label extension for osimertinib, a post-surgery treatment for lung cancer. The approval was granted in May 2021, four months after joining the initiative.

As part of the work sharing process in Access Consortium, the participating agencies divide and review different parts of the dossier. A joint review may be considered for a new chemical or biological entity application, or a new indication application that is submitted to two or more of the participating agencies:

• Therapeutic Goods Administration, Australia
• Health Canada, Canada
• Health Sciences Authority, Singapore
• Swissmedic, Switzerland
• Medicines and Healthcare products Regulatory Agency, United Kingdom

The work-sharing process is normally completed by the end of the evaluation phase as the process enters the national steps.  National laws and frameworks affecting regulatory decisions relate to product labelling, package material and subsequently reimbursement issues. Even though the review is shared, each regulator makes an independent decision regarding the approval of the new medicine.

Concurrently with the withdrawal from the EU, NICE introduced a new, refreshed strategy for 2021-2025. The strategy aims to speed up the existing evaluation pathway of new medicines. By being more proactive and working closely with the MHRA and other partners, NICE aspire to advance access for new and emerging products, including ATMPs. 

This tight collaboration is the unique feature of the ILAP. To have both the regulator and the HTA bodies jointly granting the Innovation Passport designation, sets the stage right from the beginning. The MHRA and NICE are working together to advice companies to make sure the submission can underpin how the new product can improve patients’ condition and quality of life. Incorporating this process in the regulatory pathway removes the additional assessment by HTA and payers, shortening the timelines further.  

From a regulatory perspective, the UK has put a well-balanced new system in place where flexibility and engagement are the major elements for shortening the time to get new medicines to the patients.