7 regulatory changes in life sciences and what you should do to prepare
In our recent blog we talked about the importance of resilience for life science organisations and some of the key challenges that the industry is currently facing. Among the current economic pressures, talent shortages and increased need for cybersecurity, upcoming changes to industry regulations is one challenge you can start to prepare for now.
This blog breaks down 7 regulatory changes in life sciences for 2023 and what action you should be taking to be resilient in a changing regulatory environment.
What’s behind the recent regulatory changes in life sciences?
Change is an inevitable part of life, and in recent years the industry has dealt with and risen to the challenges of this successfully. As the world moves forward from the Covid-19 pandemic and we see more and more innovations in technology, these already resilient organizations are well positioned to adapt. But can the same be said of the regulatory landscape that underpins all the activities within life sciences?
As the industry continues to innovate, this has highlighted that existing regulations need to evolve to continue to be fit for purpose in today’s world. Changes to the way clinical trials are conducted is one major example, in addition to MedTech and the increasingly important role technology is playing in all aspects of the industry.
What regulations are changing for life sciences in the coming year?
We’ve gathered together seven regulatory changes that are currently ongoing, or that you should be aware of, to help you prepare in advance, including:
- EU MDR
- EU pharmaceutical reform
- EU Clinical Trials Regulation
- ISO 15189
- ICH Q9 (R1)
1. EU Medical Devices Regulation (EU MDR)
This regulation became applicable in May 2021 and there is a transitional period in place which allows medical device manufacturers time to transition from IVDR to the newer regulation. This transition period is set to end in 2024 but the European Parliament and council have released an extension to this transition period. Here are the key points to note:
- The new deadline for high risk in vitro diagnostic devices is the 26th May 2026
- Lower risk devices have until the 26th May 2027 to transition
- The 26th May 2028 applies to specific elements of devices used in healthcare
- Manufacturers must have a quality management system implemented by the 26th May 2024 to start the transition process
This change will ease the pressures that regulatory bodies are facing in being able to work through applications in time, ensuring that we don’t see shortages of medical devices in the market, protecting patient needs.
2. EU pharmaceutical reform
A proposal for a revised EU pharmaceutical package was published in April 2023 which looks at reforming the general pharmaceutical legislation. This strategy focuses on ensuring the affordability and accessibility of medicines for patients, innovation and development, environmental sustainability and antimicrobial resistance (AMR).
This is a much-needed change, with the last revision having taken place in 2000, ensuring that the pharmaceutical regulatory environment is suitable for today’s needs. Some key points to note down are:
- This reform will replace the general pharmaceutical legislation and the legislation on medicines for rare diseases and children
- The proposal still needs to be approved by the EU parliament so there is no date in place yet and the details could change
- This is expected to be a positive change, addressing the outdated aspects of the current legislation which came to light during the Covid-19 crisis
Taking proactive steps to prepare for change, such as auditing your current quality process and ensuring regulatory data is correct and up to date is a good place to start to be ready to adapt to these changes.
3. Clinical Trials Regulation
The EU Clinical Trials Regulation entered into application in January 2022 in place of the older Clinical Trials Directive (EC). This new regulation makes it more straightforward to conduct clinical trials across different nationalities. Companies now just submit one application, making the whole approval process simpler and quicker to get started. Here are the key points to note:
- There is a three-year transitional period from the Clinical Trials Directive to the CTR. From 31st January 2025 clinical trial activity must comply with the CTR
- From January 2023, any new applications should be submitted under the CTR
- The Clinical Trials Information System is now in place for sponsors to submit applications
The European Commission (EC) Decision Reliance Procedure came into place after Brexit. This is relevant for UK companies applying for marketing authorisation from the MHRA. This procedure has been extended until the 31st December 2023. The MHRA are working on a new framework for international regulations which is expected to come into place at the beginning of 2024.
- UK organisations seeking marketing authorisation from the MHRA can apply through the ECDRP until 31st December 2023
- Be prepared for a new regulation to replace this procedure next year which is expected to be a more streamlined process
The Food and Drug Omnibus Reform Act (FDORA), contained within the Consolidated Appropriations Act, was passed in December 2022. This relates to the FDA’s drug approval process, notably allowing them to accelerate approvals for medicines that meet the conditions. These must be for the purpose of treating serious conditions where there is no comparable product currently on the market.
The main difference with FDORA is that certain criteria must be met to make sure that if a drug is getting accelerated approval that it’s safe enough to be out on the market. Some of the provisions of the act include factors such as diversity in clinical trials, bioresearch monitoring inspections, pre-approval communication and an inclusion of devices under HCEI communications. Here are some key details:
- Currently, this regulation applies to any non- US based manufacturers who import any medicines or medical devices into the US
- Companies must register and operate according to FDORA with immediate effect
6. ISO 15189
The latest version of ISO 15189 was released in December 2022. It brings the medical devices standard up to date, having last been revised in 2012. More of a refinement rather than a big overhaul, the main change places the emphasis on the patient, rather than processes. Contingency planning, data control and finding opportunities with risk management are also touched on.
7. ICH Q9 (R1)
This ICH guidance on quality risk management was revised and updated for 18th January 2023. It offers a longer document with four new subsections: formality, risk-based decision making, subjectivity and integrating quality risk management (QRM) into regulatory and industry operations. These additions give clearer and more focused guidance for organizations, helping them to implement, and get the best use out of, their QRM.
Be resilient to change with a good quality management system
One common factor in preparing for these regulatory changes is having a quality management system in place. Even if you already have one, this is a good time to audit and see if there’s anything you’re missing, or areas you could improve on. Regulators will want to see good record keeping, evidence of procedures being followed and that your data is being kept secure.
Quality management software centralizes all these activities, ensuring you have all information stored securely and that it's accessible whenever you need it. Streamline your processes, evidence compliance and keep striving for excellence.
What does the future hold for Life Sciences in 2023?
Read our guide on the latest trends for the industry and how to maintain quality as things change.Get the free guide