Good Manufacturing Practices in China
2022-03-10
China's State Food and Drug Administration prepares to strengthen the enforcement of good manufacturing practices.
After the State Drug Administration (SDA) was established in 1998, it took a firm hand in supervising China's pharmaceutical industry. SDA decided that all pharmaceutical manufacturers must meet GMP standards and obtain GMP certification before June 30, 2004. Since that time, guidances for the following products have been developed:
biological products and blood products (Dec. 31,1999);
powders for injection and infusion (Dec. 31, 2000);
injectables (Dec. 31, 2002);
all products (June 30, 2004).
SDA reissued the GMP regulations in 1999. China's Drug Administration Law states that all pharmaceutical manufacturers must observe GMPs beginning July 1, 2004. In April 2003, SDA was renamed the State Food and Drug Administration (SFDA). Although SFDA authorized provincial drug administrations to accelerate GMP examination in 2002, only approximately 3800 of the previous 6400 pharmaceutical manufacturers met GMP regulations as of July 1, 2005.
At the same time, China's government is strengthening GMP examinations. A GMP examination regulation effective Oct. 1, 2005 specifies that SFDA is responsible for establishing GMP examination standards and revision and the investigator database; examining injection, biological products, and radioactive products; and examining imported products for compliance with GMPs and international mutual recognition. The Provincial Drug Administration is only for local GMP examination for products other than injectables, biological products, and radioactive products.
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