Regulatory update: Fall 2021

Clinical Trials BC Chronicle Spring 2023 – by Jean Smart, regulatory affairs & quality officer, Clinical Trials BC

Words such as Modernization, Consolidation, and Renovation dazzle the headlines in our highly regulated clinical trial environment this Fall.  Change is most definitely the new norm. Agility is out, while Adopting and Adapting to change is now in. With our own local exciting local news on the formation of Michael Smith Health Research BC, this edition brings you very exciting news from the International Council for Harmonization (ICH) and at the national level, an update on Health Canada’s Regulatory Modernization Initiative.

 

ICH Clinical Trials Renovation

On October 6, 2021, Clinical Trials BC was delighted to share The International Council for Harmonisation (ICH) news that the revised version of the primary efficacy document known as ‘General Considerations in Clinical Trials’ was approved.

 

“The modernization of ICH is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The E8(R1) revision has incorporated the most current concepts achieving fit for purpose data quality as one of the essential considerations for all clinical trials”. – ICH

 

ICH E8(R1) General Considerations in Clinical Trials is referred to as the foundational document for Clinical Trials globally. It identifies a basic set of critical-to quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of the trial results. We have the guidance that we need to adopt to reach the levels of study design, management and conduct close to the data and study participants. Taking these concepts into practice is the adaptive next step. There are significant educational and orientation implications for clinical trial research teams in BC who should have documented training on the new elements.

 

Clinical Trials BC is poised and ready to bring research teams in BC up to date with education on E8(R1) topics including: Critical to Quality Factors, Quality by Design, General Considerations in Clinical Trials update and overview, Quality Management Systems, quality-related Risk Management, and Patient Participation & Engagement in Clinical Trials.

 

Clinical Trials BC is poised and ready to bring research teams in BC up to date with education on E8(R1) topics including: Critical to Quality Factors, Quality by Design, General Considerations in Clinical Trials update and overview, Quality Management Systems, quality-related Risk Management, and Patient Participation & Engagement in Clinical Trials.

 

Health Canada Regulatory Modernization

There is more change at the national level. Health Canada is proposing to modernize our aging regulatory framework for clinical trials related to human drugs, medical devices, non-prescription drugs, and natural health products. This is part of a larger regulatory project which includes several regulatory modernization commitments including the advanced therapeutic products (ATPs) navigation and pathways. Health Canada describes the focus of regulatory modernization in ways to increase flexibility and risk-based oversight to:

• better address the evolving clinical trial environment
• ensure continued protection for participant safety
• attract clinical trials to Canada
• be an effective model in the Canadian context

The contributions from all stakeholders across the country will be used to better inform Health Canada’s decision-making with respect to outstanding proposed regulatory, policy, and program considerations for each of the product lines. A summary report of the input can now be found on the Health Canada website What we heard: Agile regulations for advanced therapeutic products and clinical trials – Canada.ca.

If you would like to Catch up on this exciting Health Canada initiative, read the consultation paper Clinical Trials Modernization: Consultation Paper – Canada.ca

 

Next Steps

There are many more changes on the horizon! The ICH Expert Working Group is moving along in the development of what will be a set of annexes for the E6 guideline. Each annex will address in more detail a particular area to which E6 could be applied and provide a more detailed workup of the CTQ factors that should be considered. The draft of the new ICH E6 Overarching Principles guideline is available. These initiatives all make up the modernization package for clinical trials at the international level.

Incorporating the international changes and renovating the national clinical trials regulatory content and pathways will be progressive for Health Canada over the next five years.

Clinical Trials BC will strive to have the BC research community well prepared to adopt and ready to adapt!