Pharmacovigilance in Asia: Will China One Day Take the Lead?

Bryan Camoens

Jean Christophe Delumeau, Head of Pharmacovigilance Asia-Pacific for Bayer Healthcare Global R&D Centre, speaks exclusively to Bryan Camoens from Pharma IQ, on the evolution of Pharmacovigilance over the next decade.

Pharma IQ:  What are the unique risks and challenges to pharmacovigilance and drug safety faced by pharmaceutical companies in Asia?

J Delumeau: There is a lack in the harmonisation of safety reporting requirements across countries. No possibility of electronic submission of adverse events except in Japan. In China, Korea, Japan and to some extent Indonesia request AE of submissions must be in local languages, except for domestic cases to some extent. There is an increasing amount of AE cases.

Pharma IQ : Asia lacks a harmonised regulatory system for pharmacovigilance and drug safety. ASEAN has taken the first step to build an integrated pharmaceutical sector. What about the rest of Asia? How long do you think it will take and what challenges do you foresee in creating an EMEA equivalent in Asia?

J Delumeau:  The process is driven by the Pmda, the SFDA and the KFDA, for about one year, the Pmda seems really to be willing to move ahead toward increasing harmonisation and reciprocal acceptance of data. However, the SFDA is mainly focused on huge challenges in China rather than giving priority to harmonisation. I tend to foresee that harmonisation will slowly improve but I do not believe that the PMDA, the SFDA, the KFDA will build a common agency comparable to the EMEA within the upcoming 5 years. On the other hand, I view as a possibility that ASEAN countries already accepting submission of AE in local language may collaborate increasingly with support from the WHO.

Pharma IQ: The requirements for safety database systems and electronic submission of ADE/ADR reports in Asia are diverse. What steps can pharmaceutical companies and regulatory authorities take to create a comprehensive pharmacovigilance system to serve the safety of Asian patients?

J Delumeau:  Japan has an E2B compatible system already but it is very Japan-specific. Despite proposals from Oracle and WHO to support the acquisition/development of an E2B-compatible system, it seems that China will replace their current system by another non-E2B compatible one. There may be a chance to convince the KFDA to move toward E2B compatibility which is the key for electronic submission and safety data exchange across countries. One can expect the WHO to become more active in proposing the E2B compatible Vigiflow system to the health authorities of developing countries. ORACLE is also in the process of proposing Oracle-AERS to health authorities of the most developed countries.

Pharma IQ: In your view, what is the fundamental difference between pharmacodiligence or pharmacovigilance?

J Delumeau: I never use the term Pharmacodiligence. In my view, and has the mission to become further diligent in detecting safety signals and even increasingly proactive by improving risk mitigation.

Pharma IQ:  What are the challenges to safety data collection and signal detection systems, considering the complex ethnicity of Asian population? What can be done to improve the situation?

J Delumeau: In my opinion, signal detection should be done not only in the overall population, but also with regards to ethnicity, particularly in the East Asian group (i.e. Chinese Korean and Japanese who, ethnically result from the admixture of the same three ethnic groups).

As well, it would make sense to look at the "Austronesian" and "Austro-asiatic" ethnic groups which result from the admixture of a population originating from the south of China with a variety of ethnic groups who settled earlier. In most of those countries however, the collection of safety data and the participation into GPV trials is still on the learning curve.

Pharma IQ : What can be done to combat drug counterfeiting and to minimise the impact of substandard Pharmaceuticals on drug safety and pharmacovigilance in Asia?

J Delumeau: From a PV point of view, the key is to detect very early any cluster of unexpected adverse drug reaction and to inquire immediately. Regulation and repression is also key but this it is the responsibilities of the authorities of the countries.

Pharma IQ: How do you see pharmacovigilance evolving over the next decade? By the year 2020 what new initiatives will we begin to in Asian Pharmacovigilance?

J Delumeau:  Overall, harmonisation across countries should improve but China may remain a specific case until able to take the lead in the region. The overall picture in East Asia is likely to be driven by the level of success and implications of the Health reform in China. Reciprocal acceptance of clinical trial data between China, Korea and Japan should continue to improve East-Asian specific clinical trials may me increasingly requested.

Direct reporting of safety information from patients and HCP to HA should further develop so that an increasing amount of safety data will not be handled by the pharma industry. The pharmaceutical industry should expect to have to deal with an increasing amount of suspected of signals found in safety databases belonging to health authorities or independent institutions.

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