The patient was a 69-year-old man brought to the emergency room with severe chest pain. A contrast chest CT scan revealed a hematoma around the ascending aorta and a notch in the aortic wall, suggesting an intimal tear. An emergency operation was performed via standard median sternotomy under deep hypothermic circulatory arrest. Upon operation, there was a 2.0 cm intimal tear just above the right coronary leaflet, which was extended near the right coronary artery orifice. There was no specific evidence of aortic aneurysm or dissection, therefore a spontaneous rupture of the ascending aorta was diagnosed. The pathological finding was cystic medial necrosis Grade 2. His postoperative course was unremarkable and he was discharged 12 days after surgery.

Objective: To propose the best pharmacovigilance plan in Japan by comparing post marketing safety studies in Japan and the U.S.
Method: Among all of the newly approved medicines in Japan in 2010, 12 marketed products in the U. S. are selected. First, to examine the U. S. system, post-marketing safety concerns over those drugs at the time of approval in the U. S. were collected as well as its postmarketing requirements (PMR) which are studies or clinical trials that sponsors are required to conduct under one or more statutes of regulations. Then, the same drugsʼ safety issues discussed as special cautions listed during the approval process in Japan and the corresponding postmarketing safety studies were reviewed.
Result: Both countries have many safety concerns in common, however, in Japan, ongoing studies are only conventional studies, such as post-marketing surveillance studies or all-cases studies, while the U. S. conducts studies to meet each individual requirement need. Ideal post-marketing safety study designs proposed by the task force, seemed beyond sponsors capabilities, particularly with regard to conduct studies with control group, and require involvement of academia external research organizations, or establishment of the national registry system for cancer and other major diseases.
Conclusion: In Japan, Risk Management Plan (RMP) will soon be implemented in 2013, and that is expected to secure patientsʼ safety by the scientific pharmacovigilance plan with the international standard. It is an urgent task to discuss what plan is feasible in Japan and how to make the corporation of industry-government-academia a reality. (Jpn J Pharmacoepidemiol 2012; 17 (1): 55-66)