Over 40 years, Post-maketing surveillance (PMS) studies have been conducted as a legal obligation in Japan. Though the contribution of these studies to the better use of the drug has been acknowledged, there are criticisms that these PMS studies have been stereotyped and need to be improved. The ICH-E2E guideline entitled as "Pharmcovigilance Planning", agreed in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been implemented in the concerned countries. The legislation of the guideline in Japan in 2005 seems to have urged drug companies and regulatory agency to review the current PMS practices in contrast with the today's highest scientific standard. We investigated the theoretical and practical aspects of pharmacoepidemiology required when the drug company evaluates safety specification prior to developing the pharmacovigilance plan and designs a PMS study along the lines stipulated in the ICH-E2E guideline. To meet this end, we evaluated the profiles of the drug, summarized "Important identified risks", "Important potential risks" and "Important missing information" to be identified and examined the pharmacovigilance plan suggested by the regulatory agency and that proposed and implemented by the drug company. We examined those aspects for 6 new products selected from 168 drugs newly approved during the period between January 2004 and October 2006. In 5 of 6 cases, we judged that the use of a comparator group would have been appropriate to asses the association between the drug and adverse events of interest. In addition, in one half (3) of 6 cases, it would have been preferable to use the database for the patient registration and/or other types of databases. The issues of relevant legislation and the infrastructure and funding for the investigations needed to develop a desirable study design and conduct a good pharmacoepidemiology study are however beyond a single company's capacity and should be set as a national strategy. The issues of post-marketing safety in the nation is becoming more and more important as the data in the countries outside Japan are being used more often for the processes of marketing authorization application of a new drug and its approval. It is urgent to secure the practice of pharmacoepidemiology to achieve the effective post-approval pharmacovigilance studies.

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For the purpose of pharmacists to be able to be more involved clinically, the pharmacy education system in Japan was revised in April 2006 and the term length of pharmacy education was extended from 4 years to 6 years.
The Japanese Society for Pharmacoepidemiology is deeply concerned about the new curriculum which will be adopted for the 6-year course, especially the handling of pharmacoepidemiology education. Two questionnaire surveys were sent to the dean of all schools of pharmacy to inquire whether they lecture pharmacoepidemiology and, if not, what study in pharmaceutical sciences would be most closely related to pharmacoepidemiology. The surveys were conducted just before and just after the introduction of the new system, in October 2005 and July 2007. The recovery of the first and second survey were 90% and 76%, respectively.
In the first survey only 17 universities (31%) had lectures on pharmacoepidemiology but in the second survey 31 universities (57%) did, and in 55% of these 31 universities the lecture was required. The result indicates that the understanding of professors of pharmacy school regarding the lecture have been gradually promoted and they feel that pharmacoepidemiology is going to be considered to be one of the essential lectures in pharmacy education in Japan. However, many responders indicated that pharmacoepidemiology was still an immature field of study and there are few appropriate textbooks and no teaching experts, and therefore, the society should take these matters into reconsideration.

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During the post-approval period, hypotheses about potentially new adverse drug reactions (ADR) have traditionally emerged from passive surveillance systems that collect large volumes of spontaneous case reports of suspected adverse drug reactions. With signal detection by traditional (or conventional, or manual) methods, quantitative (or statistical, or automated) methods for spontaneous reporting system (SRS) databases were introduced in the late 1990’s in order to detect serious ADR as early as possible. Most quantitative methods rely on comparisons of relative reporting frequencies, also known as disproportionality analyses. In FY 2009, the Pharmaceuticals and Medical Device Agency (PMDA) plans to introduce the quantitative methods (data mining method) used on Japanese SRS database. This paper introduces the recent situation on signal detection and signal management of adverse drug reactions.

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Since the reexamination system of new drugs has been in place for about thirty years, it is necessary to reconsider its management. The time from the reexamination application of new drugs until issuance of the results takes several years recently. General drugs are applied during the reexamination application and are approved before reconfirmation of the efficacy and safety of new drugs. Therefore, the reexamination system is not effectively operated. Although the informations for proper use collected from post-marketing investigations and clinical trials, and spontaneous adverse reaction reports of new drugs, etc. during the reexamination period are utilized for its safety measures, the plan for effective use is not systematically managed. We propose an improved plan for a future reexamination system. Further, we propose the introduction of a risk management plan in Japan; the current one of which lags behind EU and US.

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As the number of electronically submitted health insurance claims increases, so does the potential for the effective use of such valuable health data to improve quality health care. The Ministry of Health, Labor & Welfare (MHLW), thanks to the IT reform initiative in 2006 calling for creation of a national database (NDB) and its effective use for epidemiological studies, is developing NDB containing health insurance claims data as well as health checks and guidance data individually linked by encryption techniques. Procurement of the software (system development) and the hardware will be completed by the end of FY2008, and gradual collection of data will start in FY2009. In the first phase (FY2009-10), the analysis of the evaluation of Health Care Cost Containment Plans (HCCCP) will be the top priority and the economic evaluation of health checks and guidance may pose methodological challenges. In the second phase (FY2011-), after a full on-line submission of health insurance claims, MHLW will start to publish the findings of the analysis. Although the governing law limits the purpose of NDB to "development, implementation and evaluation of HCCCP", a report by the committee studying the use of health insurance claims data for the improvement of quality health care called for wider use of NDB for public interests in February 2008. Also, JSPE submitted a statement to the Minister in late 2007 calling for the use of NDB for pharmacoepidemiological purposes. For the opinions and demands of JSPE to materialize, continued support and effort from the members is greatly appreciated.

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The drug use-results survey, as well as the spontaneous reporting system, is an important measure to collect the post-marketing safety and effectiveness information of drugs;many drugs have already been evaluated.
The data collected through the drug use-results surveys is submitted to the authorities as part of the application documents for drug reevaluation, but has seldom been used for pharmacoepidemiological research despite its potential for such use.
We propose the authority to make full use of the drug use-results survey data for pharmacoepidemiological research by developing a database of the collected data after standardization of the survey items such as adverse events, and disease-specific background information of patients.

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