In an effort to improve the Japan drug lag problem, the Japanese government plans to initiate several programs to simplify and optimize its drug clinical trial program. First, there are too many systems for clinical trials in Japan including the PMD Act, Clinical Trials Act, Safety of Regenerative Medicine Act, and requirements for gene therapies. The PMDA plans to make these clinical trial programs more consistent. In an effort to do this, one Japanese health ministry group has promoted the idea of centralized Institutional Review Boards (IRBs) as an alternative to individual IRBs.
Also in discussions are ways to amend the good clinical practice regulations including constructing a standardized patient consent form, updating clinical trial processes (such as protocol changes), best ways to organize decentralized clinical trials, etc. In addition, the MHLW is expanding ways to make post-market surveillance studies more efficient and no longer enforces a singular PMS regulation. For example, Japan should have more flexible PMS policies in cases where there are no safety issues due to ethnic differences, or when there is sufficient safety information already available for an additional indication.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------