At the AAPS annual meeting in New Orleans, Toshiyoshi Tominaga, PhD, of Japan’s Pharmaceutical and Medical Device Agency spoke about recent efforts of his agency to further global regulatory harmonization. In particular, he discussed efforts to coordinate and collaborate with close neighbors South Korea and China.
China-Korea-Japan Tripartite Relationship
Since 2008, the three nations’ regulators have been meeting regarding greater coordination, establishing a working group on the matter in Beijing in 2009. In Seoul in September of 2010, the group met to discuss two key issues: how “ethnic factors” play a role in clinical trials and drug development in the three countries; and how better information exchange regarding clinical trials can be established.
Regarding the “ethnic factor” research, the three countries are all considered principal researchers, and are conducting studies (focusing primarily on pharmacokinetic patient data) of how certain drug molecules impact ethnic Chinese, Japanese, and Koreans, and whether differences and similarities in patient response might be better understood and documented. The goal of the tripartite research is to compare data with each other, as well as to compare it with data being gathered on clinical patients around the world.
PMDA and the World
Tominaga then discussed PMDA more widespread harmonization activities, with the Asian Pacific Economic Consortium (APEC) countries (which include Canada and the U.S.). A recent meeting in Seoul included discussions of: clinical trial study design, operational aspects of collaboration, the Korea-China-Japan ethnic factor research, as well as several case studies on oncology trials and regulation.
After this meeting, Tominaga said, Japan proposed to MRCT the “implementation of ICH E5 guideline and promoting harmonization on Regulatory Procedures on MRCT in order to facilitate MRCT and acceptance of foreign clinical data for drug review.”
Finally, based upon similar programs held by CDER and CBER in the U.S., the PMDA will this month (late November) host several days of training seminars for international regulatory authorities. “This is our first attempt to do something like this,” Tominaga noted, and representatives of seven other countries have committed to sending trainees. On the docket will be an overview of Japan’s regulatory process, and meetings on various scientific and technical aspects of drug review.
Finally, Tominaga shared several insights regarding the challenges of international regulatory collaboration:
- International regulatory activities (meetings, training sessions, etc.) are costly, he said, and their benefits difficult to quantify. Collaborating regulators must set clear goals for their work together, and take a long-term view. For example, Tominaga said, “Ten years from now, we hope that Japan will have one of the three strongest regulatory authorities in the world . . . if I take this view, my travels and work now can be justified.”
- International harmonization includes two components: the harmonization of advanced technology; and global implementation of harmonized guidance. Today, he noted, if technologies and guidance are not agreed upon and used globally, “there is not much to gain. Harmonization beyond the ICH participating countries is important.”
- Bilateral cooperation, and win-win situations, are indispensable, he said. “How can we convince, for example, China and Korea that these gains are theirs as well? So we work hard to discuss the gains for all parties in bilateral cooperation.”