Helmut
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Vienna, Austria,
2016-09-28 22:55
(2737 d 16:46 ago)

Posting: # 16691
Views: 6,389
 

 1,000+ Chinese NDAs rejected due to fabricated or incomplete clinical data [BE/BA News]

Will it ever stop?

The China Food and Drug Administration (CFDA) has withdrawn 1,184 drug registration applications following a recent yearlong government investigation into clinical trials in the country.

http://www.outsourcing-pharma.com/Clinical-Development/Chinese-drug-applications-rejected-due-data-issues

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
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DavidManteigas
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Portugal,
2016-09-29 12:37
(2737 d 03:04 ago)

@ Helmut
Posting: # 16692
Views: 4,939
 

 It's all about the money

I can't understand how sponsors risk their business for 40 ou 50k€

I know that generics is a business of spend the less amount possible to win the most. But the difference in price of a bioequivalence study in China/India or Europe sometimes does not worth the risk of these things happen and ruin the entire image of the generics industry. At least in Portugal, even the medical comunity don't trust generics and generic companies. And this news just make things worst.
ElMaestro
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Denmark,
2016-10-01 00:58
(2735 d 14:43 ago)

@ DavidManteigas
Posting: # 16697
Views: 4,836
 

 It's all about the money

Hi David,

❝ I can't understand how sponsors risk their business for 40 ou 50k€


yes, that's right but there are many nuances.
People in Gx companies who solicit these trials are often in a terrible bind. They may get fired if they don't meet their annual goals, and that may involve a certain number of trials within a given and unrealistic budget. They do not necessarily have freedom to operate within what we would call reasonable limits. It is easy enough for you and I to say this is the recipe for failure but you try and explain that to a penguin who fiercely guards his spreadsheet and basically doesn't give a sh!t because he isn't a scientist and does not understand what quality is. he understands what money is. Like you say. All about money.

I could name several people who were forced into buying trials from subpar CROs and afterwards were sacked because the CROs were caught cheating. If you see a way to get rid of the Lean concept in the way it is currently being totally used and misused in the industry then there is a way forward. I have no idea myself. It has to involve a buy-in from top management, not from middle managers.

Finally, this isn't actually about just Generics. It is also about innovator meds.

Pass or fail!
ElMaestro
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