There are three key clinical development regions in Asia, namely India, China, and South East Asia. Each of these regions
offers similar attractions and poses similar questions with respect to the placement of global clinical trials.
Photography: Comstock Illustration: Paul A. Belci
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The similarities between the regions are the attractions of rapid patient recruitment driven by large patient populations
with diseases of both the developed and developing world and fewer competitor trials as compared to North America and Europe.
In addition, there could be a substantial potential for cost savings as well as the opportunity to penetrate some of the fastest
growing pharmaceutical markets in the world.
Regulatory approvals process
Although regulatory approval timelines are longer in Asia as compared to North America, they are the most prolonged and uncertain
in China. In Singapore and Korea, regulatory processes are the most streamlined, quick, and predictable. Regulatory approval in China for clinical trial initiation may take up to nine months as the approvals dossier navigates its
path through six regulatory approval bodies, as shown in Table 1. The potential for delay at any one of these bodies contributes
to the unpredictability of the process. Factoring in this lengthy regulatory approval process is essential while planning
clinical trials in China. A thorough understanding of the local regulatory requirements is necessary to ensure that the dossiers
are correctly assembled to keep delays to a minimum.
Korea is positioned at the other end of the spectrum, with its regulatory processes streamlined such that the Korea Food and
Drug Administration (KFDA) is able to deliver approval for a clinical trial application within 30 working days. Furthermore,
the Institutional Review Board (IRB) approval process occurs in parallel.
Table 1. Six regulatory bodies in China must examine a clinical trial prior to granting approval.
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In Singapore, the average regulatory approval period is four weeks followed by an additional four to six weeks for site-level
IRB/ethics committee (EC) approval. In Hong Kong and Taiwan, parallel processing of regulatory and IRB/EC approval is possible
and takes on an average eight and ten weeks, respectively, to obtain both approvals. This is followed by a further two week
wait to obtain the license to import clinical trial supplies.
Over the past two years, the regulatory approvals process in India has become progressively more streamlined, with median
approval times reduced from 16 to 10 weeks. Approval from local ECs at the site level is processed in parallel. If biological
clinical trial samples need to be exported, then additional approval from the Directorate General of Foreign Trade is required,
a process that takes four to ten weeks. Because the Drugs Controller General of India (DCGI), driven by the increased volume
of international clinical trial applications, has become more experienced and better resourced, the uncertainty regarding
regulatory approval times has substantially diminished. This phenomenon will be notable in numerous emerging countries as
their nascent clinical development environments become more mature with time.
Evolving intellectual property protection legislation
ACTBITS
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The local pharmaceutical industry in Asia has historically been dominated by generic pharmaceutical companies. Not surprisingly,
therefore, innovative pharmaceutical sponsors have concerns about the protection of their intellectual property (IP) in these
countries. However, IP protection legislation in Asia is evolving as a result of international pressure as well as domestic
economic development.
