Reference standards: 18 are on the market, 24 have undergone batch changes, and 4 have been discontinued.
Release Date:
2020-09-28
On September 27, the National Institute for Food and Drug Control of China released the latest update on the supply of national pharmaceutical reference standards (Issue No. 10, 2020), which includes information on 18 new varieties slated for market launch, the anticipated launch dates for 24 varieties undergoing batch replacement, the remaining shelf life of 24 varieties set to expire, and a list of 4 discontinued varieties.
The National Institute for the Control of Pharmaceutical and Biological Products will no longer conduct quality monitoring on reference standards whose validity period has expired, as well as on non–latest batches of reference standards for which no validity period is specified (generally referring to older batches not listed in the National Catalogue of Pharmaceutical Reference Standards). Users who continue to use such materials are responsible for verifying their certified values and suitability. In cases where information on the same batch of a product is published at different times, the most recent announcement shall prevail; if discontinuation information for a product is released within its validity period, the discontinuation notice shall take precedence. 
The latest update on the supply of National Pharmaceutical Reference Standards for Issue No. 10 of 2020 is hereby released, including information on 18 new varieties slated for market launch, the anticipated launch dates for 24 varieties undergoing batch replacement, the remaining shelf life of 24 varieties nearing expiration, and a list of 4 discontinued varieties. Detailed information can be found in Tables 1, 2, 3, and 4.
Our institute will no longer conduct quality monitoring on reference materials whose shelf life has expired or on non–latest batches of reference materials for which no specific shelf life is specified (generally referring to older batches not listed in the National Catalogue of Pharmaceutical Reference Materials). Users who continue to use such materials are responsible for verifying their certified values and suitability. In cases where information on the same batch of a product is published at different times, the most recent announcement shall prevail; if discontinuation information for a product is released within its valid usage period, the discontinuation information shall take precedence.
China National Institute for Food and Drug Control
Standard Reference Material and Standardization Management Center
September 27, 2020
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