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.

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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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