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:
The MHRA has stated its intention to explore the inclusion of other regulatory authorities to the IRF in the future.
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.
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 31st, 2023 when it then extends the list of countries whose assessments it will recognise.
The new IRF will offer numerous benefits for patients, companies and the MHRA.
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.
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.
April 13, 2023
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...
December 18, 2020
2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...
July 25, 2022
What is ILAP? What benefits does ILAP provide? How do you access it? With the dust of Brexit settling, the question on most people’s lips (well, those of us in the healthcare sector anyway!) was:...