It’s complicated!

An estimated 43% of the world’s innovative treatment pipeline originates in the Asia Pacific (APAC) region.

While not all sponsors plan to market treatments beyond the country of origin, many do. Those sponsors with global ambitions must decide which regulatory route offers the most strategic advantages and which market, particularly between the EU and US.

Each route has relative merits and challenges depending on the treatment in development and its commercial goals. In this article we outline some common challenges APAC sponsors are likely to encounter when seeking EMA or FDA authorisation.

While all cross border trading is challenging, drug developers face even more complexity in this highly regulated sector. Following regulatory best practices can mitigate delays or refusals.

Collaboration with the right partner overcomes knowledge gaps and other barriers to set APAC sponsors on a course for global success.

To avoid potential submissions issues, we strongly advise early engagement with the EMA through their scientific advisory service.

Designing a study aligned with EMA expectations from the outset will be more efficient and cost effective than retrospectively adapting a clinical trial after it starts or ends.

EMA regulatory concerns about APAC originating trials frequently include limited representativeness of European populations and use of comparators that are not aligned with EU licensed standards of care.

Reviewers may also question heterogeneity in race, inclusion criteria and diagnostic approaches. Additional challenges include premature termination of efficacy studies, particularly in oncology, and potential ethnic differences in treatment response.

Some APAC regulatory agencies, notably Japan’s PMDA, align more closely with the FDA than others. For biotechs in those countries, this makes their FDA submissions more straightforward.

However, others may have to adjust trial designs to comply with FDA expectations, including dosing, endpoints and relevant participant demographics. Differences in ICH alignment between some APAC countries and the FDA may also require additional planning.

Policy changes and trade tariffs may make it more difficult for biotechs in certain APAC countries to pursue FDA authorisation, and these changes are more likely to affect China.

The Trump administration has designated China as a “hostile” territory and banned the transport of cells from American trial participants to Chinese labs.

Continued uncertainty and the potential impact of the reduced FDA headcount are also factors to consider.

One of the most effective ways to avoid barriers to global authorisation is to design trials that anticipate multi regional approval from the outset.

Resources such as ICH E5 and ICH E17 provide sponsors with frameworks to follow, which emphasise early planning for population representativeness and regional applicability.

A CRO with deep regulatory and clinical expertise will identify gaps, advise on global trial design and ensure that APAC generated data meets global regulators’ expectations.

ICON has helped APAC sponsors achieve their goals and gain FDA and EMA authorisation.

With expertise across a range of therapeutic areas, we have supported Orphan Drug and Fast Track Breakthrough designations and authorisations of innovative treatments across multiple therapeutic areas through both FDA and EMA routes.

Before choosing a regulatory route, APAC biotechs with global ambitions should read ICON’s latest whitepaper at www.iconplc.com/APAC-ambition.