The role of pharmacoepidemiology in drug surveillance is becoming more important as there has been an increasing number of social issues concerning post-marketing drug safety in accordance with the increasing number of swift approvals of innovative new drugs with high potency and efficacy due to the progress of medical and pharmaceutical sciences.
The ICH E2E guideline for pharmacovigilance planning has been finalized as Step 4 and comprehensive risk management planning is being proposed in EU and US. Pharmacoepidemiology is thus an indispensable factor in safety surveillance.
On the other hand, guidelines for conducting observational studies to investigate the potential safety issues do not exist in Japan. The guidelines for post-marketing safety surveillance observational studies presented here were drafted by referring to various observational studies and guidelines used by foreign companies for post-marketing surveillance and by taking into consideration, the feasibility of implementation in Japan.
There are two parts in this report-the first part of the report describes goal, scope and principles such as standard matters, and the latter part illustrates the details of observational cohort study and nested case control study that are likely to be conducted by companies. Relevant groups will be requested to review the draft guideline to refine the contents for implementation and it is expected that pharmacoepidemiological studies would contribute to the post-marketing safety measures to be taken.