After the United Kingdom officially left the European Union at the end of 2020—the so-called Brexit event—its Medicines and Healthcare products Regulatory Agency (MHRA) was no longer a member of the European Medicines Agency (EMA) and needed to develop and assert an independent identity as the regulator of product registration and quality in the United Kingdom

At the FDA/Xavier PharmaLink conference held virtually in Spring 2021, MHRA Inspection Strategy and Innovation Deputy Unit Inspector David Churchward discussed his agency’s transformation into a “sovereign regulator,” including its shifting regulatory approaches, a new licensing pathway, and international collaboration.

[Related: Click here to access a report analyzing the UK MHRA 2019 GMP inspection deficiency findings by leading industry expert Barbara W. Unger.]

MHRA 2019 Special Report

MHRA Moving to Lifecycle Approach

Churchward explained that MHRA has been developing its own regulatory approach, as a sovereign regulator independent of EMA, and adapting to changes and trends.

“We are in the process of making four key shifts that will transition to a lifecycle regulatory approach” (Figure 1).

Figure 1 Four Key Shifts for MHRA
FIGURE 1 | Four Key Shifts for MHRA
  • “We will reposition from the traditional controller approach to a health systems enabler, while maintaining high standards of safety and independence and decision-making,” he said. While the agency will retain its power to take regulatory action where needed, Churchward emphasized that “2020 has shown the importance of regulators engaging with industry to bring innovative products quickly and safely to the market.”
  • “We will maintain our global voice through international collaboration and leadership, innovative regulation, new technologies, clinical trials, and setting clinical standards.”
  • “We will be responsive to patient needs and build on the huge capabilities of MHRA’s clinical practice research database. It takes real world data to help decision-making.”
  • “And the United Kingdom’s unique national health system structure and links with health economics assessment, via the National Institute for Health and Care Excellence, will position MHRA as a health system partner rather than just a black box decision-making organization.”

Three Pillars of Transformation

To enable the agency’s shift in regulatory approach, MHRA is focusing on three key pillars of transformation (Figure 2).

Figure 2 Three Pillars of Transformation
FIGURE 2 | MHRA – Three Pillars of Transformation

The agency will be inventing new regulatory processes that integrate with the health system to bring innovative products to market using a prioritized review and approval process aimed at enabling earlier patient access.

New, innovative products will be able to use adaptive authorizations and benefit from risk analyses using real-world data from the United Kingdom’s integrated healthcare system.

“We will use a strengthened evidence base built for greater access to source real-world data to simplify our regulatory processes and engage regulatory science, which continues to adapt to scientific developments,” Churchward emphasized.

Innovative Licensing and Access Pathway (ILAP)

A key new regulation coming forth from the UK will be the Innovative Licensing and Access Pathway, or ILAP. The aim of the new pathway is to enable the efficient and timely development of medicines and to reduce the time to market for those innovative medicines.

The ILAP “combines our broadly recognized regulatory strengths with efficiency and flexibility,” Churchward asserted. It is intended to provide a single integrated platform for collaborative work between MHRA, healthcare partners, and new medicine development.

A new medicine designation “Innovation Passport” will access a gateway to enable entry into the pathway. The passport will be awarded to innovative products submitted to the ILAP program based on innovation and patient need enabling ILAP to encompass a wide range of medicines and therapies, including advanced therapies, medicines for rare diseases, and repurposed medicines.

We will reposition from the traditional controller approach to a health systems enabler, while maintaining high standards of safety and independence and decision-making

A successful innovation passport designation allows regulatory partners to create a Target Development Profile, or TDP. “This gives MHRA a unique, product-specific road map towards patient access in the UK health care system,” the Deputy Unit Manager said.

The TDP includes access to tools that can be selected to design an efficient and what is called a “regulation- and access-ready development program.” Available tools include adaptive inspections, novel clinical trial design and dossier pre-assessment, and continuous risk/benefit assessment together with streamlined licensing procedures.

International Collaboration

MHRA has a long history of international collaboration and continues to expand in its new global position. It has been a party to many Mutual Recognition Agreements (MRAs) established through its previous membership in the European Union, and the agency has negotiated new MRAs with existing partners on the same terms as previously. In addition, a new MRA with the European Union was agreed as part of the Trade and Cooperation Agreement in 2020, which enables recognition of the GMP inspections performed by each party.

MHRA’s partnership and leadership in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the International Coalition of Medicines Regulatory Authorities (ICMRA) continue across a range of regulatory harmonization and innovative working groups. Additionally, MHRA intends to continue its participation in the International Conference on Harmonization (ICH) and the International Medical Device Regulators Forum (IMDRF)—the medical devices equivalent of ICH.

The agency is also participating in Project Orbis, which is an FDA-coordinated initiative with participation from Australia’s Therapeutic Goods Authority (TGA), Health Canada, Singapore’s Health Sciences Authority, Swissmedic, Brazil’s ANVISA, and MHRA, spearheaded by the FDA Oncology Center of Excellence (OCE).

Project Orbis provides a framework for concurrent submission and review of oncology products among international partners and line extensions in oncology. It provides a coordinated review and priority timetable for products that provide “meaningful improvement” over existing therapies.

The final addition to MHRA’s international collaboration is participation in the ACCESS Consortium with colleagues from Australia, Canada, Switzerland, and Singapore. This enables Web sharing in review of regulatory findings that enables a national marketing authorization to be granted by the participating members.

A Time of Change and Opportunity for MHRA

“This is a time of significant opportunity for industry and regulators to build on our experience from the last 12 months,” Churchward commented. “We have been able to act flexibly, focus on outcomes rather than being constrained by process, and more than ever used our networks to ensure patients continue to have access to safe medicines.”

…a new MRA with the European Union was agreed as part of the Trade and Cooperation Agreement in 2020, which enables recognition of the GMP inspections performed by each party

It has also been a time of change for the MHRA with new collaborations, regulation processes, and “most importantly” an agency focused on flexibility and creativity.

“And throughout all of this, we will be maintaining and enhancing our participation in global regulatory networks, offering leadership and support to international collaboration work for the benefits of patients out of industry,” the MHRA inspector maintained.

Onsite Inspections

Regarding whether the days of onsite inspections are numbered, Churchward commented, “I do not think so just yet. But like many areas of health, I think the pandemic has forced us to adapt to different ways of working. Some are effective. Some might be effective with a little more work. And others might not be in good effect.”

He believes that remote inspection promises the ability to react faster to emerging incidents, particularly international incidents, and that it will also enable MHRA to use highly specialized resources to inspect high-tech manufacturing processes, big data, and AI approaches. “Ultimately, this might actually enable better risk-based inspections,” he said.

For the future, Churchward sees a hybrid inspection approach, where refined tools for remote assessment enhance a reduced level of onsite presence. He maintains that the approach could also apply to industry and supply chain management.

Q&A Focuses on Post-Approval Changes

In the Q&A after Churchward’s presentation, a participant commented, “MHRA plays a leading role in helping transform how regulatory agencies handle post-approval changes which drive a lot of complexity and reduce industry’s ability to better serve patients with today’s complex and diverse regulatory schemes. Your thoughts?”

Churchward replied, “For many years, we have participated as a European agency within the ICH network. But we intend to continue to collaborate with ICH in our own right. We will be there contributing and, where appropriate, leading work, not just initiatives like ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.”

“Regarding Q12, there is work ongoing in terms of training and we are participating in an initiative through PIC/S to develop inspector training to facilitate Q12 implementation. That is partly a collaboration pilot between PIC/S and ICH.”

“Harmonization is key to be able to deliver things like Q12. The wider harmonization piece that we will be involved in will help to reduce some of the complexity and diversity in regulatory schemes, which ultimately will, I hope, move toward the aim of Q12, which is a more streamlined approach to post-approval changes.”

[Related: Click here to access a report analyzing the UK MHRA 2019 GMP inspection deficiency findings by leading industry expert Barbara W. Unger.]

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