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Regulatory convergence or divergence for Asian pharma

20 September 2018 Sophie Cairns

Asia is seeing increasing convergence between some of its major markets and the United States and Europe, according to the conclusions of the first panel discussion at The Pharma Market Access and Pricing Summit Asia that opened on the 19th. China, for example, has introduced priority review pathways, including for hepatitis C treatments and life-threatening, which have helped shorten the drug approval gap between China and major overseas markets.

Still, speakers tended to agree that for the foreseeable future, Asia would remain characterized more by its differences than similarities in regulatory approach. The faultline lies mainly between Asia's more mature markets - such as Japan, South Korea, Taiwan, Thailand - and the region's emerging markets, most of which are in Southeast Asia such as Vietnam and Indonesia.

Asia's markets are spread quite widely across the spectrum that ranges from a more innovative approach to a more conservative one, with regulatory agencies having to decide whether they lean more towards a focus on public health, or more towards speed of market access when it comes to evaluation timelines.

A key factor for the difference in regulatory approach is different perceptions of a treatment's value. During a second panel discussion on expanding access in emerging markets in Asia, Kathleen Yeoh, director of corporate affairs and market access for ASEAN at Eli Lilly, noted that regulators in Asia's pharmerging markets are familiar with quantity concept of cost, but less so with the concept of value in terms of how approving a treatment can lead to economic and health dividends. Given that the actual cost savings for a newly-approved drug can take a few years to kick in, and regardless of the forecasting models provided by drug makers, "in the end we end up discussing price" rather than the drug's value.

There are some signs of regulatory convergence in the Association of Southeast Asian Nations (ASEAN). One example is the ASEAN Common Technical Dossier (ACTD), a guideline on a common format for the preparation of Common Technical Dossier (CTD) applications to register medicines. However, for the time being regulatory divergence in Asia looks here to stay. As AstraZeneca's Singapore country president How Ti-Wei put it: "I don't see country-specific requirements going away any time soon."

Posted 20 September 2018 by Sophie Cairns, Senior Analyst, IHS Life Sciences

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