Contributed By Jones Day
Pharmaceutical advertising may refer to data on file or other clinical studies not included in the Summary of Product Characteristics (SmPC). However, references to data on file or clinical studies are limited in certain ways by law and by self-regulatory codes.
First, the general rules on advertising (such as prohibition of false or exaggerated advertisements and advertising that recommends unapproved drugs or off-label uses) under the PMD Act will apply.
Second, references to data on file or other clinical studies shall be subject to the specific regulations provided by the JPMA Drafting Guidelines. For example, statements shall only concern indications approved in Japan. In addition, the study must be published in a peer-reviewed journal.
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