Pharmaceutical CompaniesWhat is reported:
There is no minimum threshold for reporting.
- R&D expenses such as joint research expenses, research commissioning expenses, clinical study expenses (expenses related to clinical research in and after Phase 1), post-marketing clinical study expenses, adverse drug reaction/infection case reporting expenses, post-marketing surveillance expenses and other expenses
- Payments related to academic research grants, including scholarship donations, general donations, donation to academic societies, etc., and expenses of co-sponsored conferences, etc.
- Honoraria, including lecture fees, manuscript writing fee/supervising fees and consulting/commissioning fees
- Payments related to provision of information, including expenses for meetings, lectures, educational sessions expenses as well as medical/pharmaceutical literature and other supplies
- Other payments
- Excluded payments:
- Payments made by overseas affiliates
- Payments made to recipients whose primary place of practice is outside of Japan
- Payments to patient organizations
Medical Device Companies
What is reported:
- Research and development expenses
- Academic research support expenses
- Manuscript writing fees, etc.
- Expenses related to information provision
- Other expenses
- This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
- Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
- Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
- “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
- The information does not take into consideration:
- Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
- Transparency related to patient organizations (unless the patient organization is considered an HCO)
- If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).
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