Comments for China Bio Law

Comment on Globalization and the Export of Chinese Pharmaceutical Regulation by Elaine

Elaine — Wed, 22 Dec 2010 02:49:07 +0000

I am also looking into pharma regulatory affairs, and I got some good readings:

ICSR submission requirements in Asian countries
Pharma regulatory affairs and pharmacovigilance practices in Vietnam
Principles of Drug Management for Malaysia
Regulatory Requirements in Thailand

Here is the link: http://pharmaregulatoryaffairsasia.com/Event.aspx?id=432446

Comment on About the Author by Elaine

Elaine — Wed, 08 Dec 2010 07:56:00 +0000

Hey, Your blog is great! I am working on a pharma regulatory affairs project and I have been searching content on the website, that’s how I found your blog.

Will be interested in writing something about the regulatory affairs in China? For expample, how to shorten the approval time for new drugs?

Thanks,

Elaine

Comment on Globalization and the Export of Chinese Pharmaceutical Regulation by andrei

andrei — Fri, 26 Nov 2010 09:20:25 +0000

Thank you for bringing up India’s equally strong position as a pharmaceutical player, sometimes I get tunnel vision when it comes to China! I think it will be terribly interesting to see which of their pharma industries comes out on top. While India has a nice head start (here’s a 2008 report on this very topic, by the Kauffman Institute; it touches on the high levels of entrepreneurship in the Indian industry as well as the familiarity that Indian companies already have with FDA approvals), I think that one reason China gets so much attention is that people believe it has yet to hit its stride.

It may also be that effective regulation and enforcement are not necessarily the most important factors when it comes to China’s ability to define regulatory standards outside of their own borders. Given the cost-savings and potential for market development (mainly 1.3 billion potential purchasers), it may be enough that international companies focus their R&D and sales efforts in China, or other similar regions, because they see a better potential for profit there than back in their home markets. If China can accrue a critical mass of business to themselves, the worry is that there will be a regulatory race to the bottom as other jurisdictions lower their own standards to stay competitive. Of course, that’s all very theoretical and speculative, and whether or not that scenario could actually play out is anybody’s guess.

Thanks again for your comments, there’s so much more to say about everything you’ve brought up but I think I’ll have to save it for another post! An India/China comparison maybe?

Comment on Globalization and the Export of Chinese Pharmaceutical Regulation by MXT

MXT — Fri, 26 Nov 2010 04:12:42 +0000

great piece, I’m glad I came across this.
some comments:
while SFDA certainly has potential to define regulatory standards, I think there is still a fair way to go. For me, their biggest hurdle is developing a legal system that also has successful enforcement measures as well which will give laws on paper credibility and force. Having guidelines which no-one, least of all their own citizens don’t comply with will make it difficult for anyone to take them seriously.
Also, how about competition with India? While both it and China are developing countries compared to the US, I wonder if India doesn’t have a bit of an edge over China in the pharmaceutical arena. Its language for correspondence in this area is English; legal system is more in sync with western countries and its a big player in the TRIPS/generic medications regime. Its R&D I’m not so sure about, but its drug manufacturing sector is certainly going strong.
looking forward to your next piece on FDA and SFDA!

Thanks,
MXT

Comment on Norweigian in Beijing: Successful Brain Cancer Treatment? by MM

MM — Sat, 18 Sep 2010 22:42:23 +0000

Hello,

I was wondering if anyone has heard any more about this particular case or anyone else who is undertaking this treatment from Cellonis Tech. I am interested to find out for a loved one. I have tried to find out but cannot find anymore on the net. Please help.

Thanks
MM

Comment on Norweigian in Beijing: Successful Brain Cancer Treatment? by Dr. Jim Roberts

Dr. Jim Roberts — Sat, 18 Sep 2010 17:07:31 +0000

Hello,

Great post! I would like to know more about this. I am a doctor of alternative cancer treatments and I think this is a development in cancer treatments.

Jim Roberts

Comment on Lions and Tiger-substitutes and Bears, Oh My! by bioinformatics training

bioinformatics training — Sat, 18 Sep 2010 03:52:32 +0000

Yah that’s really true that a number of tiger farms were set up in order to harvest the tigers for trade, and after the ban they ended up becoming tiger parks, where the tigers put on shows for tourists

Comment on The Rose-Fingered Dawn of China Biotech by Bangalore Biotech

Bangalore Biotech — Thu, 27 May 2010 11:17:53 +0000

Nice article. Looking at the situation of Chinese biotech I can say that Indian Biotechnology Industry has developed rapidly in past few years.

Comment on Growing Pushback from China's Patent Laws by Growing Pushback from China's Patent Laws « China Bio Law | China Law | China's Law

Wed, 24 Mar 2010 13:38:50 +0000

[...] View original post here: Growing Pushback from China's Patent Laws « China Bio Law [...]

Comment on Norweigian in Beijing: Successful Brain Cancer Treatment? by andrei

andrei — Mon, 15 Mar 2010 19:43:03 +0000

Poggi,

There is nothing new about the particular case I wrote above, and I don’t know about any others who have undertaken this treatment with Cellonis, I will try and contact them about this.

-Andrei