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Japanese eccentric regulation in pharmaceutical industry1

I am currently in charge of planning post-marketing clinical trials to support product positioning. But, here in Japan, its regulation is really eccentric comparing with other countries. Publicly, drugmakers can't fund any specific study which is related to their marketed products and is initiated by physicians, following anti-trust act.
But in real practice in Japan, all drugmakers fund specific study under the name of unrestricted grant. To be legal company, any drugmakers can't publicly admit this fact that they are supporting specific studies.

After my new boss joined us, he changed our policy, to clear the compliance problem above. Extensively and differently interpreting sentences in anti-trust related act, he says we can publicly support specific study except for funding and drug supply. And he tries to implement new process which needs US-HQ approval to support specific study. This process brings our company catastrophe.
In his policy, there are two points to consider. One is whether his interpretation is really compliant with law, another is its difficulty to implement that policy practically.
As to 2nd point, I will clarify next time.

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what is US-HQ approval ?
In other way, it would be no sense follow with such a stupid boss!
Like this fullish company, someday they could be bankruped as some big finantial company in New York!

投稿: jacky | 2008年6月24日 (火) 13時14分

> Hi Jacky,

In my current company, its headquarter (HQ) is located in US.
In their SOP, US-HQ is supposed to approve any request to our support for clinical study.

投稿: 夢見るK | 2008年6月29日 (日) 18時17分

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