Global Regulatory Convergence — What If?

Earlier this year, a small group of industry leaders met at PDA headquarters in Bethesda to begin outlining approaches that might be helpful in moving the important topic of global regulatory convergence forward.

The decision to hold this framing session resulted from industry conversations that began at the Global Regulatory Convergence Roundtable held at PDA Week 2024. A link to a summary of the roundtable published in the PDA Letter can be found at the end of the article.

The roundtable focused on the importance of global regulatory convergence in speeding innovation to the patients who need it. Today, global regulatory submissions for new products (and for post-approval changes requiring a submission) require lengthy and repetitive submission, review, inspection (where required) and approval processes for each country or regional regulatory authority. The process to achieve full global approval today takes many, many years. The roundtable focused on discussing how to move this important topic forward and how to accelerate it to ensure patients with life-threatening conditions or who are at extreme risk of infections due to current and future pandemics and epidemics have the medicines they need.

Three points that came out of the roundtable resonated with the framing group:

• Industry needs to be speaking with one voice.
• Science must not be compromised as regulatory processes converge.
• The ultimate goal or target (which we all understand is a significant stretch) should be one submission, one inspection (if required), one assessment and one approval (globally accepted).

In mapping out the current, ongoing industry and regulatory activities related to convergence, a clear pattern emerged: A large number of overlapping work efforts are occurring in the same space by different agencies and organizations. With so many experts working on similar topics in so many different directions, the framing group concluded it is no wonder progress has been slow, delaying patient access to critical medications.

As the framing group meeting in Bethesda pondered this reality, a proverbial lightning strike occurred:

What if PDA took a radically different global approach? What if we were to break down regulatory convergence into specific deliverables or elements (a sort of master plan) and then ask the industry as well as regulators to support and endorse specific groups (one for each deliverable) with the task of delivering the regulatory convergence elements needed within a specific timeframe?

This would entail focusing all the effort and support behind each group and suspending support for competing projects. This is a radically different approach, but if the patient is at the center of what we (as industry and regulators) do, and if ensuring patients get the medicines, they need is the ultimate goal (especially those with life threatening conditions or at extreme risk of infections due to current and future pandemics and epidemics), isn’t a more radical approach appropriate?

So, what would this look like in general from a process standpoint? Good question.

Perhaps the first step would be to develop the full list of deliverables (elements) needed. This could be followed by identifying the proposed group or team best prepared to deliver the element within a reasonable timeframe.

For example, let us take the element of developing standardized global inspection reports. Could the International Coalition of Medicines Regulatory Authorities (ICMRA) with some additional representative or the Pharmaceutical Inspection Cooperation Scheme (PIC/S), that has already been working on this topic, be the right group to drive the delivery of this element? I know these might not seem like the logical groups to some, but could they be based on their expertise? How about the element of standardizing the final pieces of a global framework for regulatory submissions? Would the International Council for Harmonization (ICH) be the right candidate? And so on and so on.

Whatever the approach may eventually look like, the key point is that the industry must begin speaking with one voice on what it believes is needed regarding regulatory convergence. Then, in collaboration with the regulatory authorities, we can develop the elements (deliverables) needed and identify a proposed group that should be focused on delivering that element. Industry and the regulators share an important goal in ensuring patients have the medicines they need when they need them, and global regulatory convergence can help all of us meet this goal. The one nonnegotiable in all of this is that we must not lose our focus on the science in this convergence.

If you like this topic and want to contribute, join us at the PDA Week 2025 roundtable on Speeding Innovation Through Global Regulatory Convergence on 7 April 2025 in Palm Springs California.

For more information regarding the roundtable discussion at least year’s PDA Week, click here.