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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 Research Analyst, Life Sciences
