Stakeholders discuss potential IMDRF reliance playbook, guidance

WASHINGTON – While regulators around the world are using reliance to get products to market sooner and more efficiently, some stakeholders say the International Medical Device Regulators Forum (IMDRF) should consider developing a playbook to help them navigate the different regulatory regimes and bring more clarity.

On Monday, IMDRF kicked off its 25^th Management Committee meeting, hosted by the US Food and Drug Administration (FDA), with a focus on regulatory reliance. Regulators from around the world discussed how they have used reliance as a mechanism to review products that other advanced regulators have already evaluated to get those products into their own markets faster.

During a panel discussion about using reliance with regulators from different jurisdictions, Tammy Steuerwald, global head of regulatory policy at Roche Diagnostics, proposed that IMDRF should develop a playbook or guidance on the issue.

"I have had multiple regulators bring up, 'How do we operationalize reliance?’” said Steuerwald. “I'm hearing more and more about how do they operationalize reliance, not should they implement reliance.

“Perhaps IMDRF could take some lead on a guidance or a playbook that would help people adopt the right reliance for their jurisdiction," she added.

Several panelists discussed what they would like to see in such a document.

Tracey Duffy, first assistant secretary at the Medical Devices and Product Quality Division of the Australian Therapeutic Goods Administration (TGA), noted that IMDRF already has a working group that is developing ways for sponsors to submit their applications in a consistent way so that they would not have to worry about submitting their applications differently for different regulators. If a reliance playbook is ever developed, she said that would likely be part of it.

Duffy also noted that later in the week, attendees will hear from FDA and Health Canada, who have been piloting an electronic version of their medical device submission form. Ultimately, she said lessons from that pilot may be added to a potential playbook.

Woei Jiuang Wong, assistant group director at Singapore’s Health Science Authority (HSA), said that IMDRF has a working group developing good review practices, and their work should also be included in a potential playbook to help ensure review harmonization across regulatory regimes.

Maria Luz Pombo-Castro, unit chief for Quality and Regulations of Medicines and Health Technologies (IMT/QR) at the Pan American Health Organization (PAHO), said she is interested in addressing good regulatory practices for publishing regulatory decisions by more advanced regulators. In particular, she wants to know the minimal amount of information stakeholders should be required to submit by advanced regulators when deciding on a product that is already on the market in other regions.

After the panel discussion, Steuerwald told Focus that many jurisdictions want to know how to implement reliance, especially considering that there are different types of reliance, such as unilateral and mutual reliance. On top of that, she noted that people want to know the difference between regulatory reliance and recognition.

Steuerwald said a playbook or guidance should help stakeholders understand the basic requirements they need to meet for reliance, how different jurisdictions apply reliance, and what the different models of reliance look like. She noted that IMDRF should consider working with the World Health Organization (WHO) on the issue since they already have a good reliance document and a global model regulatory framework that already outlines that.

"It's just kind of like a how-to document, taking into consideration the uniqueness of each jurisdiction's starting point,” said Steuerwald. “We'll see what happens. I'll keep my fingers crossed."

Earlier in the day, Diane Würzburger, an executive regulatory affairs officer at GE Healthcare, noted that WHO in Annex 10 of the WHO Technical Report Series defines reliance as an action where one regulatory authority relies on another regulatory authority or trusted institution in its regulatory decision-making. However, she added that it was imperative the regulatory authority maintains its independence, responsibility, and accountability for its decisions even when it relies on another institution.

“We’ve heard there is some confusion out there, different interpretations of what reliance is or is not, who can consider this approach, when can it be used,” said Würzburger. “Perhaps that’s an opportunity for the [IMDRF] management committee and for all of us here to consider as we go through today and look at the opportunities to move forward.”

Stakeholders discuss potential IMDRF reliance playbook, guidance

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