Contributed By Jones Day
As the transparency requirements under the Clinical Trial Act would apply only to the marketing authorisation holder and its subsidiaries, the requirements would not apply to foreign companies or companies that do not sell products on the market in Japan.
The transparency requirements under trade association rules such as the above-mentioned Transparency Guideline only bind members of such trade associations. Accordingly, the transparency requirements under the self-regulatory rules will not apply to foreign companies and/or companies that do not yet have products on the market, unless such companies are members of trade associations with transparency requirements.
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