Case Study: Challenges in Japan on Post-Marketing Surveillance – Observational Study and EPPV Programme

In a session that will be discussed in detail at the 3rd Annual Pharmacovigilance Asia 2012, Dr. Shinichi Nishiuma, Senior Medical Advisor & Lead physician of Global Patient Safety in Japan for Lilly Research Laboratories Japan, talks about the future challenges in Japan’s pharmacovigilance market with Bryan Camoens.

He also talks about the most common challenges faced when examining post-marketing surveillance systems in Japan, and poses the questions as to whether EPPV is actually working to minimize the risk of patients or just wasting resources.

B Camoens: In your opinion, what are some of the best practices and future challenges in Japan on post-marketing surveillance – observational study and EPPV Programme? 

S Nishiuma: I think the important point is the optimization of observational study and EPPV. As there is a tendency for planning of these things to fall into simple but non-scientific rationale, this needs to be improved and we need to consider what information we can obtain and provide HCPs with appropriate information when they treat patients.
B Camoens: When it comes to examining the post-marketing surveillance systems in Japan, what are some of the most common challenges faced?

S Nishiuma: Medical and scientific perspective vs. regulation and Japanese customs. There is a difficulty to set a comparator arm in observational study, and the sample size is usually bigger with PMDA instruction.

B Camoens: In your opinion, what are some of the challenges faced in the early phase post-marketing vigilance (EPPV) programme in Japan?

S Nishiuma:Optimization for resource is not working well. For example the intensity of EPPV could be lowered in the 2ndor 3rdindication of the compounds. However the companies do not raise the problem and PMDA tend to take a conservative approach to do the same thing. There is room to improve in terms of using resources optimally.

B Camoens: How do you go about evaluating the unique regulatory requirements in your country and could you please explain the backdrop for signal detection and risk management?

S Nishiuma: Basically there are some additional requirements in Japan regulation (eg. EPPV and observational study), so in this sense, it may be working better than other regions. One point to be improved is the approach of risk management was not systematic as it always starts with how we see the risk before having enough discussion on what the risk is. Now RMP guidance was officially notified by MHLW in April 2012 and I believe things will be improving.
B Camoens: In your opinion, how do you go about exploring approaches to shape EPPV to comply with local regulatory requirements?

S Nishiuma: Compliance with EPPV regulation is not the big issue. The bigger issue is that we need to validate whether EPPV is actually working in terms of pharmacovigilance activity leading to minimizing the risk of patients. In near future, we need to assess the effectiveness of EPPV.

B Camoens: Given the amount of investment in the sector, how will pharmacovigilance evolve over the next decade?

S Nishiuma: Evaluation of risk minimization activities will be of great importance considering the effectiveness of the activities in relation to resources we spend. We have to allocate resources appropriately to conduct effective PV and risk minimization activies.

Dr. Shinichi Nishiuma, will be talking about the risk management protocol selected to facilitate efficient project execution at the 3rd Annual Pharmacovigilance Asia 2012. Email to register for the congress or visit for the complete list of speakers and topics that will be discussed at the 3rd Annual Pharmacovigilance Asia 2012.

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