Presenting at this year’s Outsourcing Clinical Trials East Asia 2017 in Seoul, Novotech CRO Chief Executive Officer Dr John Moller presented an overview on the opportunities and challenges of conducting multi regional clinical (MRCTs) trials in Asia.
During his presentation, Dr Moller reviewed the breadth of regulatory changes which took place throughout Asia in 2017; and discussed the progress with implementation of International Council for Harmonisation’s E17 Guidelines (ICH E17) on ‘General principle on planning and design of Multi-Regional Clinical Trials’, which will enhance both sponsors and CROs’ ability to undertake MRCTs in Asia.
“In Asia, we are seeing the dual effects of cooperation to enhance regulatory harmonisation with some regulatory competition as governments see the benefits of clinical trials to their economies and health sectors. They are working hard to reduce many previous barriers to entry; such as reducing regulatory hurdles, decreasing clinical trial approval and start up timelines, and increasing levels of government support. In 2017, we have seen:
- China’s FDA significantly restructure many aspects of its regulatory framework with the changes outlined in Circular 53 now being implemented.
- Malaysia prioritise its clinical trial industry as part of its Economic Transformation Program and launch its first Phase I Clinical Trial Guidelines.
- South Korea now cover the standard of care of patients participating in clinical trials.”
- “While other countries within Asia have worked to streamlined their regulatory approval processes:
- India has greatly simplified its regulatory approval process in a bid to revitalise its clinical trial industry.
- Singapore has moved to a risk-based Clinical Trial Authorisation and Notification system, reducing the review of applications from 30 working days to just 5.
- Taiwan has reduced its timelines for First In Human (FIH) trials.
“Asia as a region is greatly increasing its international role and level of competitiveness as a clinical trial destination on a global scale. In the past year, we have seen the number of Asian countries involved in the International Council for Harmonisation increase, with both China and Singapore becoming ICH members,” said Novotech Chief Executive Officer Dr John Moller, “But despite these positive efforts, it is important sponsors appreciate regulatory regimes are heterogeneous. Institutional Review Board approvals, regulatory, import licensing and contract negotiations are undertaken simultaneously in some countries and sequentially in others. This is where working with a regional CRO can make all the difference to the success of a clinical trial. With their country-specific experience and strong relationships with local KOLs and institutions, they will guide you through each country’s unique and changing regulatory environment, ensuring time is not wasted.”
With 13 offices in 11 countries throughout in the Asia Pacific, Novotech actively works with each country’s regulatory authorities and key clinical trial centres to improve approval processes and timelines. Novotech is committed in providing our clients with access to the untapped benefits available in the Asia Pacific region.
As the leading Asia Pacific CRO, Novotech continues to grow in the region with the:
- Launch of a site monitoring (SMO) business to support clinical trial activity in South Korea and Taiwan
- Signing of two MOUs with leading clinical trial networks in South Korea
- Launch of a central labs service in Australia
For more information about the untapped clinical trial benefits available in Australia and Asia,
Download a free copies of the Frost & Sullivan white papers, ‘Asia: Preferred Destination for Clinical Trials’ or ‘Australia: Preferred Destination for Early Stage Research’
Or feel free to contact us.
About Novotech - www.novotech-cro.com
Headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I - IV clinical trials in the Asia Pacific region.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence included running clinical trials in all key regional markets. Novotech also has worldwide reach through the company's network of strategic partners.
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