Asia-Pacific is well-known as a culturally sensitive region, presenting opportunities but no shortage of pitfalls in the world of clinical development. Of the top challenges in global clinical trials disrupting all regions, including delays in patient recruitment, global language challenges, and most urgently, increased regulatory guidelines, perhaps none are as complicated to navigate as in APAC countries.
In two recent executive roundtables hosted by language industry expert Slator, key decision makers gathered in Singapore and Japan to respond to updates in global regulatory compliance for clinical trials. Among the senior clinical trial professionals at the Singapore roundtable was Maija Burtmanis, Regional Compliance Director at Shire; the Japan meetup was led by Haig Oghigian, Attorney & Senior Counsel at Squire Patton Boggs.
Both forums hashed out compelling discussions on compliance, vendor management, mitigating legal and compliance risks, and PMDA activities—all in the context of rapidly changing legal environments in both countries. Here are the most important takeaways clinical operations and regulatory professionals will need to know from each:
Updates on the Clinical Research Act
Published in April 2017, the new Clinical Research Act is still fresh in everyone’s minds—especially drug makers’, who may be impacted the most in light of regulatory compliance for clinical trials in Japan. Unlike the U.S. and Europe, Japan only loosely controlled pre-market trials and the use of clinical data. Under the new Act’s provisions, drug makers will need to conduct “Designated Clinical Research” under Good Clinical Practice (GCP) standards.
Fortunately, the aim is to make GCP rules not stricter, but more reasonable. For example, monitoring the development of drugs or medical devices will follow a risk-based approach and utilize quality management systems.
Chinese health sector developments
“From a legal perspective, if there is one thing we must be concerned about, it is how to get the interpretation of the language right,” said Burtmanis, who has worked as a senior lawyer and compliance professional in Russia, India, and most of Asia-Pacific. Her main concern, as raised in the Singapore discussion, was that only four APAC countries speak English as a first language, making interpretation of data and regulatory compliance crucial.
Recent developments in China regulations, including the government’s move to subsidize and encourage big pharma to invest in domestic R&D initiatives, appear to be good news for tech, life sciences, and automation sectors. However, global (and even local) firms operating in China may struggle to keep up with international standards.
Change cycles in Japan pharma
According to Oghigian, change has unfolded rapidly in Japan over the last few decades. Since the 1950s, when big pharma companies were in their early days and only needed business acumen to survive, core competencies in the industry have evolved to experience working with regulators, getting high prices for products, and the ability to shift or refocus resources. Finally, in today’s era of “execution,” the central differentiator is ability to change.
Regulatory fluctuations certainly aren’t set to slow down soon, so the next task atop many companies’ minds is adapting quickly—and finding language industry partners to help along the way. Conducting clinical trials across several locations often requires the partnership of third-party contract research organizations (CROs). Now, says Burtmanis, seems the best time to select providers with the most experience to achieve robust systems for success.