Clinica INSIDE CHINA: Will Green Channel truly signal speedier entry?

Screen Shot 2013-10-18 at 11.30.07 AMThis month sees the launch of China’s fast-track approval process for innovative devices.  Michael Alper discusses the implications for foreign companies

March 2014: Inside China – Will Green Channel truly signal speedier entry?

As part of the government efforts to encourage innovation in the medical device space, the CFDA recently enacted a “Green Channel” policy that allows for an expedited registration process for “innovative” medical devices.  This policy was originally proposed in 2013 with the intention of only being applicable to Chinese companies with domestically made products.  However, with pressure from the international community including foreign governments, AdvaMed and other associations, the policy was modified to also be open to foreign manufacturers.  This policy officially went into effect on March 1, 2014 and there has been a lot of discussion in the media and in the medical device community about the applicability of this policy and how to take advantage of it.

One common concern that I have seen published in the foreign media is related to a line in the policy which states as a requirement that the product’s operational rational or working mechanism “is domestically initiated in China,” which would seem to mean that at least part of the product’s R&D would need to be developed in China and in line with the original intent of the policy.  However, the original text “为国内首创” could also be read as “is innovative to China” meaning that such a product has not been sold in China before.  As other parts of the policy include specific references to “foreign applicants” including usage of local representatives or representative offices to support submissions, and does not differentiate requirements for foreign applicants, I believe that the second meaning is valid.  This is also based on consulting with native speakers on my team who are of the same opinion.  Thus from a purely textual perspective, the policy seems to give equal footing to both domestic and imported products with both having requirements related to local patent filing.

Prior to this policy, there has been a “Green Channel” policy for drugs in effect first enacted in 2009 and then modified in 2013 whose intention was to encourage domestic innovation.  The policy itself did not specifically mention domestic applicants versus foreign applicants and theoretically could be applied to both.  However, I have heard from friends in pharma that MNCs are having difficulties even getting their locally developed locally manufactured subsidiaries’ products accepted under this policy.

Thus based on the pharma example I do have concerns about how the new medical device policy will be executed.  However, though the new medical device policy like the pharma policy was originally devised with the intention of promoting domestic innovation, the fact that it specifically mentions foreign applicants means that the CFDA should allow at least some imported products to be approved under this policy.  In fact much of the supporting documentation that is required to prove that the product is “innovative” such as academic papers “that sufficiently explain the product’s value in terms of clinical application” will be easier to provide for imported products because at the time of application submission the products would have likely already been used in a clinical setting whereas domestic products would not likely have had such an opportunity.

However, when there is subjectivity in the reviewing process such as what it means for a product to have “safety or efficacy to be fundamentally improved as compared to similar products” so as “to have significant clinical value” I would think that the CFDA would be much stricter in its interpretation when it comes to imported products and much more lenient when it comes to domestic products so as to be consistent with the original intention of the policy: domestic innovation.

As for how much time will be saved with this policy, it is still not clear.  The policy has many references to giving priority to products that are deemed innovative but this is only after an evaluation that is supposed to be completed within “40 working days.”  Furthermore, the policy specifically states that clinical trial requirements (ie. whether or not a trial is required, the size of the trial, etc.) will be the same whether or not a product qualifies for the expedited channel.  Thus for a product that requires a clinical trial, the amount of time that can be saved as a percentage of total time is quite small since a trial can often take up to two years.

As the policy has just been initiated, even the reviewers are unclear about how this policy will be handled.  Until a few products have gone through this process it will be difficult to determine how this process will be handled for a particular product and the amount of time that can be saved.  However, as the CFDA will give priority and resources to this channel, it might mean that resources will be taken away from other channels, which might in effect slow down the normal registration path.  Either way, I believe that the new process for innovative devices will be faster than the standard process.  Since every day a product is not approved is a day of lost sales, I do believe it is worthwhile for all companies with innovative products to try utilizing this process.

On March 31, 2014, posted in: News by

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