Read the full article: Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business:
"“It’s not just for the U.S. FDA, also the China FDA is understaffed as well,” said Jonathan Chan, an analyst in Hong Kong with Decision Resources Group, citing the size of the industry and the large number of drug applications. “It’s quite overwhelming. With agencies being understaffed, quality control and standards will get compromised.”"
'via Blog this'
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Showing posts with label china. Show all posts
Showing posts with label china. Show all posts
Thursday, October 1, 2015
Monday, June 11, 2012
P.R. China - Good Manufacturing Practice for Drugs (2010 Revision) - In English - Free
Updated March 24, 2020
The link in the original post broke.
You might also be interested in:
Chinese and English Translation GMPs -
SFDA Good Manufacturing Practice for Drugs (2010 Revision) ( MOH Decree No. 79 )
- - - the original post follows below - - -
The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.
The document has 43 pages and is divided into 14 chapters with 313 paragraphs.
The link below takes you to the free English language version of the doucment.
State Food and Drug Administration, P.R.China (SFDA) - Ministry of Health (MOH) Decree No. 79 - Good Manufacturing Practice for Drugs (2010 Revision):
"Article 1: These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, are enacted to regulate the manufacturing and quality management of Drugs."
'via Blog this'
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The link in the original post broke.
You might also be interested in:
Chinese and English Translation GMPs -
SFDA Good Manufacturing Practice for Drugs (2010 Revision) ( MOH Decree No. 79 )
- - - the original post follows below - - -
The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.
The document has 43 pages and is divided into 14 chapters with 313 paragraphs.
The link below takes you to the free English language version of the doucment.
State Food and Drug Administration, P.R.China (SFDA) - Ministry of Health (MOH) Decree No. 79 - Good Manufacturing Practice for Drugs (2010 Revision):
"Article 1: These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, are enacted to regulate the manufacturing and quality management of Drugs."
'via Blog this'
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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Related articles
- FDA Compliance & Enforcement - Inspection of Cosmetics: An Overview (drughealth.blogspot.com)
- FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers (drughealth.blogspot.com)
Thursday, January 19, 2012
US counterfeit drug seizures up 200 per cent in 2011
Updated May 11, 2022
The original link broke.
You can still read about the same topic here:
--- the original post follows below ---
"China remained the primary source of counterfeit goods across all categories, representing 62 per cent of all seizures by value, with the value of pharmaceutical seizures from China increasing by more than $4.3m and the value of perfume seizures up $7m on the prior year.'via Blog this
Meanwhile, India and Pakistan both featured in the top 10 source countries in 2011, mainly due to seizures of counterfeit pharmaceuticals. Pharmaceutical seizures accounted for 86 per cent of the value of seizures from India and 85 per cent from Pakistan, said the CBP.
The top 10 source countries - in descending order - were: China; Hong Kong; India; Pakistan; Taiwan; Switzerland; Malaysia; South Korea; UK; and Mexico."
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Labels:
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Monday, November 15, 2010
Drugs and Supplements From China Still Largely Unregulated
Updated February 9, 2021
Links in the original post broke.
People also ask about:
- - - original post follows below - - -
I'm most concerned about, "One consequence of the lack of regulation has been a rising number of counterfeit drugs."
Related links:
GAO Report Blasts FDA for Failure to Implement 2008 Recommendations
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Labels:
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Saturday, December 20, 2008
And The Top 10 Food Stories Of 2008
. . . according to QSR Magazine's article, "The Top 10 Food Stories of 2008," include some concerning food safety items. If you're in the food chain supply, or are just interested as a consumer, here's the quick list of the stories . . .
- The rise in food prices around the world
- China's tainted milk scandal
- The salmonella outbreak in raw tomatoes
- Supermarket Chains Offer More Locally Grown Food
- New USDA Labeling Laws
- Big Food Companies Adopt Nutrient Standards
- Jalapeno Peppers Test Positive for Salmonella
- Paul Newman Dies
- NYC Restaurant Trans Fat Regulations
- New Levels of Alarm Associated With High Salt Intake
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