Contributed By Jones Day
In Japan, advertisements for medicines do not require prior authorisation from, nor notification to, any regulator.
There are no laws or regulations currently in effect that require companies to make particular arrangements for ensuring compliance with the pharmaceutical advertising rules – or to adopt certain procedures or hire specific personnel. However, the new Detailing Guidelines require that companies establish internal systems to ensure appropriate conduct with respect to promotion activities. This includes establishing an independent department responsible for monitoring promotional materials and promotion activities, as well as a supervisory review board to advise the monitoring department.
Currently, the JPMA Promotion Code requires that JPMA member companies establish internal systems to comply with relevant laws, regulations and industry self-regulations, appoint a promotional material officer and establish an in-house oversight system so that only reviewed promotional materials and advertisements are used. The promotional material officer must have a deep enough understanding of medical and pharmaceutical practice and must have an appropriate educational background; he or she shall be responsible for the management of advertising and promotional materials such as product information brochures. A senior management officer may become a management representative if qualified professionals in the medical advisory division can support and advise the officer.
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