Japan stem cell laws (fast track)

[James7]

Just starting this thread so we can collect/share information and discuss the details of the new Japanese 'fast-track' stem cell laws.

The Japan Times:
http://www.japantimes.co.jp/news/201.../#.U9_TEaNZhCO

Wall Street Journal (press release):
http://online.wsj.com/article/PR-CO-...24-900716.html

Nature magazine (5th paragraph):
http://www.nature.com/news/seven-day...r-2013-1.14242

Japan has passed two regenerative medicine laws on 20th November 2013.

One law speeds the approval of stem cell treatments by no longer requiring candidate therapies to pass the rigorous (and enormously expensive) phase 3 clinical trials to prove efficacy.
Another law requires physicians to report the clinical use of unapproved stem-cell therapies to the Japanese health ministry.

'The new regulations will be implemented within a year.' (says Nature Magazine).

So I gather from this, that companies need to just prove safety and complete their phase 2.
They can then market their commercial product.
And I expect the efficacy of the treatment, will then determine the product's commercial success.

Safety of course is the most important factor, so I'm pleased about that.
Seems that proof of efficacy is not required, as far as I can tell from these articles?

Since the laws have already been passed, to be honest I'm not sure what the 'implemented in a year' means exactly, unless they are refering to when the first stem cell companies happen to be processed under this new law?
From looking at past clinical trials, it always seems to be the enormously expensive phase 3 that in the past have just halted companies in their tracks before.

When reading about these new laws, as long as they complete phase 2 and prove safety, it seems certain that Replicel and Histogen will come to market and be available.
So I guess we might all be booking some tickets to Asia in the near future?

So let's discuss this, and if you have any more info/details on this, that's great too! add it all below