Table 3 R&D payments subject to disclosure under in the JPMA Transparency Guidelines and the ABPI Code
JPMA Transparency Guidelines (2018) | ABPI Code (2019, 2021) | ||
|---|---|---|---|
Research activities | Reported information | Research activities | Reported information |
Clinical trials, post-marketing clinical trials, adverse drug reaction/infection case reports, and post-marketing surveillance conducted under GCP/GVP/GPSP ordinances | Organisational-level recipients, number of contracts, value of payments (JTG2018, Chapter 5, 3, Publication Subject, A, Research and development expenses, etc) | Clinical trials defined consistent with Directive 2001/20/EC [125] | Total value of all R&D payments per company, without naming recipients or distinguishing organisational and individual recipients |
Specific clinical research conducted under the Clinical Trials Act [73] | Organisational-level recipients, organisations conducting research, research Identification number recorded in the Japan Registry of Clinical Trials, the name and affiliation of the principal investigator of the research institution, the name of the contract research organization number of contracts, value of funding (JTG2018, Chapter 5, 3, Publication Subject, A, Research and development expenses, etc) | ||
Research carried out under the Ethical Guidelines for Medical and Health Research involving Human Subjects issued by Ministry of Health, Labour and Welfare [126] | Name of facility to which funds are provided, number of contracts, value of funding (JTG2018, Chapter 5, 3, Publication Subject, A, Research and development expenses, etc) | Prospective non-interventional studies | |
Non-clinical research, for example basic research, pharmaceutical research | Name of facility receiving funding (JTG2018, Chapter 5, 3, Publication Subject, A, Research and development expenses, etc) | Non-clinical (laboratory) studies following the OECD Principles of Good Laboratory Practice [127] | |
Other costs | Costs associated with meetings that are not paid to medical institutions, etc. (e.g., venue fees, food and beverage costs, and travel expenses; costs of tests, etc. not paid to medical institutions) (JTG2018, Chapter 5, 3, Publication Subject, A, Research and development expenses, etc) | No equivalent ABPI payment category | - |