Making Global Regulatory Harmonization a Reality

By Nicole Taylor Smith, Vice President, Global Head, Regulatory Science & Policy, Philips

Making Global Regulatory Harmonization a Reality

As we prepare for the 2024 MedTech conference, I find myself reflecting on the inspiration I took from last year’s event. The passion and commitment of everyone I met on the event floor left me more energized than ever. It was clear how proud our industry is to be part of delivering life-saving care solutions to patients.

Looking back, we’ve made significant progress, particularly in advancing global regulatory harmonization. While there’s still work to be done, we’ve come a long way. I’m excited about how these strides will continue to better serve patients around the world by making care more accessible and efficient. Last year’s discussions underscored the importance of patient safety, quality assurance, and market access—all key drivers of regulatory harmonization.  

As I look ahead to MedTech 2024, I’m particularly excited about the session on Regulator Perspectives, where regulatory leaders will discuss the critical need for harmonization and the opportunities available through global frameworks using recognition and reliance. Today, manufacturers face multiple, often conflicting regulatory processes to introduce new products across different countries. This slows the delivery of life-saving technologies and creates risks that patients in certain markets may not get access to these critical products. However, during the COVID-19 pandemic, we saw unprecedented cooperation and faster approvals—proving what’s possible when urgency and trust align.

At the upcoming session, we’ll hear regulator updates from Canada, the United States, Brazil, Japan, and the United Kingdom on each countries’ efforts toward harmonization. We’ll also hear an update from the recent International Medical Device Regulators Forum (IMDRF) and the important efforts the organization is taking to promote global best practices and harmonization across jurisdictions. IMDRF is making measurable strides toward global frameworks and shared pathways, building upon current platforms already utilizing reliance and recognition.

Keeping global patient access as our north star, I’m confident we can continue to progress towards a single submission and even review in the future!  These efforts will ensure accelerated access to life-saving technologies, improve patient outcomes, and ultimately enhance lives globally.

By Nicole Taylor Smith, Vice President, Global Head, Regulatory Science & Policy, Philips

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