5 Strategies for APAC Drug Submissions: Korea, China, Japan

Korea, China, and Japan are no strangers to clinical trials in Asia. They have large patient populations and sophisticated regulatory systems and infrastructure, and each has worked to adopt the CTD or eCTD for submissions. That said, they also require the most content to be presented in-language to local regulators. So how do you manage up to five million words of critical content translation across 330 files and submit on time?

In July, TransPerfect presented at Bio Asia-Taiwan’s One-on-One Partnering” event, where the hot topic facing Taiwan’s booming biotech industry was “How can we get our drugs registered in China quickly?” Leading the conversation was Alicja Borek (Senior Director, Asia), Wei Du (Director, China Strategy), and Silas Chen (Account Management, Taiwan). TransPerfect presented our five-point plan to enable smoother submissions:  

1. Stakeholder Alignment: Regulatory, medical writers, CMC, nonclinical, R&D, and project management are among the stakeholder groups involved in generating content for CTDs. Schedule a kick-off meeting with your language services provider to establish key project milestones, identify internal and external stakeholder groups, set up department-level workflows, and determine which tasks can be outsourced. Planning ahead allows your team to remain nimble and focus on responding to the authorities and reduces the risk of entering a critical submission path.
2. Process and Milestone Management: Whether you are submitting a traditional CTD or working with an XML-backboned eCTD platform, a workflow management system is essential. TransPerfect can integrate into your content management system to help your team push and pull content directly from the source and send it out for processing, review, translation, etc. Each stakeholder group can have its own unique workflow and processes pre-programmed into TransPerfect’s translation management system, GlobalLink. This reduces the team’s project management, and all key indicators are visible within the platform. Tasks, milestone dates, groups, reviewers, and glossaries are all connected into one system.
3. Modules Sequencing: With Module 2 containing summaries of Modules 3–5, following a module sequencing approach in project setup helps you optimize your translation memory and cut down your turnaround time. While medical writers draft the relevant Module 2 summaries, work can be done on Modules 3–5 that can later be reused when Module 2 is ready.
4. Make Your R&D Work for You: Was the study performed in-house or outsourced to a CRO partner? Which language services provider did the CRO use for R&D? Answers to these questions can further reduce your timeline by giving you more content to leverage. Establishing a translation memory sequencing approach unlocks all of your R&D work on the compound/molecule and puts it to work for you to shorten your timelines. No need to pay the same bill twice.
5. Optimize Review: Lessen the burden for your medical writers and internal teams who validate content by optimizing the review process. Having a review platform as part of your workflow management system allows glossaries, style guides, and formatting templates to be linked into one view. Reviewers can hide repeat content and not rely on human memory for consistency.

Through TransPerfect Life Sciences’ Regulatory and Clinical Practice groups, we simplify the process for you. From drafting a project submission plan to designing department-level workflows to handling millions of pages of translation to Module 2 medical writing support to producing the entire dossier—We Know How. Contact lifesci@transperfect.com to learn more about how our five-point plan has helped to submit over 30 dossiers in 2019 alone in these critical Asian markets.