Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business

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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.”"

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P.R. China - Good Manufacturing Practice for Drugs (2010 Revision) - In English - Free

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Updated March 24, 2020

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Chinese and English Translation GMPs - 
SFDA Good Manufacturing Practice for Drugs (2010 Revision) ( MOH Decree No. 79 )

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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."

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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)

US counterfeit drug seizures up 200 per cent in 2011

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Updated May 11, 2022

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US fake drug seizures up 200% - outsourcing-pharma.com

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SecuringPharma - US counterfeit drug seizures up 200 per cent in 2011:

"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.

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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Drugs and Supplements From China Still Largely Unregulated

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Updated February 9, 2021

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Safeguarding Pharmaceutical Supply Chains in a Global Economy - FDA.gov

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Probably not surprising, and certainly disappointing, as reported by this KansasCity.com news article, Drugs, supplements come to U.S. from China largely unregulated.

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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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 . . .

1. The rise in food prices around the world
2. China's tainted milk scandal
3. The salmonella outbreak in raw tomatoes
4. Supermarket Chains Offer More Locally Grown Food
5. New USDA Labeling Laws
6. Big Food Companies Adopt Nutrient Standards
7. Jalapeno Peppers Test Positive for Salmonella
8. Paul Newman Dies
9. NYC Restaurant Trans Fat Regulations
10. New Levels of Alarm Associated With High Salt Intake

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