International Recognition Framework (IRF): Are You Ready?

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new international recognition framework (IRF) for medicines and devices. The IRF will be in place from January 1st, 2024, enabling the MHRA to consider decisions made by other regulatory authorities when assessing marketing authorisation applications.

The new framework is part of the MHRA's commitment to ensuring that patients in the UK have timely access to safe and effective medicines. Additionally, it will help to reduce the regulatory burden on companies that are developing and marketing new medicines.

The MHRA has initially nominated seven international regulatory counterparts to participate in the IRF. These are:

• Australian Therapeutic Goods Administration (TGA)
• Health Canada
• Medicines and Healthcare products Regulatory Agency (MHRA)
• Swissmedic
• United States Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• Japanese Pharmaceutical and Medical Devices Agency (PMDA)

The MHRA has stated its intention to explore the inclusion of other regulatory authorities to the IRF in the future.

Inside the International Recognition Framework: Exploring Key Components

The MHRA will assess marketing authorisation applications (MAAs) against the same standards as it does now. However, if a decision has already been made by one of the nominated regulatory authorities, the MHRA may decide to rely on that decision. This will help to speed up the assessment process and reduce the need for duplication of work.

• Initially the framework will be used for medicines and medical devices, with the potential for future extensions to other products.
• The MHRA will only recognize decisions made by regulators that meet its own high standards. It also it reserves the right to refuse recognition of a decision if it believes that the product does not meet the UK's safety, efficacy, and quality standards.
• The IRF will employ a risk-based approach. The MHRA will assess the risk of each medicine and determine whether to rely on the decision of another regulatory authority.
• The IRF will be voluntary. Pharmaceutical companies will not be required to use the recognition framework.
• The framework will be reviewed on a regular basis to ensure that it is meeting its objectives.

The new framework is a significant development for the MHRA and for the UK pharmaceutical industry and will help to ensure that patients in the UK have timely access to safe and effective medicines, while also reducing the regulatory burden on companies.

This is not a totally new initiative though. Currently, MHRA have a European Commission Decision Reliance Procedure (ECDRP) whereby MAA's can be submitted to MHRA once the Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received for the EU MAA. MHRA rely on the decision taken by the European Commission, rather than fully reviewing the "Great Britain" MAA (GB MAA). This ECDRP procedure is expected to continue until December 31^st, 2023 when it then extends the list of countries whose assessments it will recognise.

Benefits of the new IRF

The new IRF will offer numerous benefits for patients, companies and the MHRA.

• Benefits for patients: The new framework will facilitate timely access to safe and effective medicines for patients in the UK by expediting the evaluation of marketing authorisation applications, reducing the time it takes for new medicines to reach them.
• Benefits for companies: The new framework will help to alleviate the regulatory burden on companies that are developing and marketing new medicines. This is because companies will only need to submit a single marketing authorisation application to the MHRA, even for seeking approval in multiple countries. This will save companies time and money.
• Benefits for the MHRA: The new framework will enhance the efficiency of the MHRA by enabling the sharing of assessment activities with other regulatory authorities. This will help to ensure that the MHRA can continue to provide a high level of service to patients and companies.

Industry Reactions to IRF

The IRF has been warmly welcomed by industry groups, who commend its potential to accelerate the availability of new medicines in the UK. According to the Association of the British Pharmaceutical Industry (ABPI), the IRF is seen as "a positive step" that "will help to ensure that patients in the UK have access to the latest medicines as quickly as possible."

However, some critics have raised concerns about the IRF. They argue that it could lead to a "race to the bottom" in terms of safety and quality standards. They also worry that the IRF could give too much power to large multinational pharmaceutical companies.

The MHRA has stated its commitment to addressing these concerns. For example, the MHRA will require regulatory authorities that are part of the IRF to meet certain standards of safety and quality. The MHRA will also have the power to refuse to recognize decisions made by regulatory authorities that do not meet these standards.

Next Steps for IRF

The MHRA is expected to provide further details about the framework in the coming months. This initiative is anticipated to build upon the existing ECDRP introduced after Brexit, which allows for the recognition of EMA applications with a positive CHMP opinion. ProPharma have significant expertise with supporting submissions via the ECDRP route and are excited to expand expertise to support future submissions via this new international framework. ProPharma have found the ECDRP review to be efficient and quick with MHRA and can provide guidance and advice to Companies considering ECDRP or IRF as to what the requirements are (certain documents need to be prepared for the GB MAA) as well as how to mitigate the frequent comments/questions received from MHRA and the timelines that the MHRA have been working to.

In conclusion, the MHRA's new IRF represents a significant development that has the potential to expedite the availability of new medicines in the UK. However, it is crucial to closely monitor the system to prevent any compromise in safety and quality standards.

ProPharma is primed to support clients by providing strategic guidance and procedural expertise to ensure clients can benefit from this initiative on its implementation. Contact ProPharma today to learn how our strategic guidance and procedural expertise can support your company in effectively navigating the new MHRA IRF, ensuring a seamless implementation while upholding safety and quality standards.