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Recently, the General Administration of Food and Drug Administration no. 164 of 2015 issued YBB00032005-2015 "sodium calcium glass infusion bottle" and other 130 items of direct contact with the packaging materials and containers of drugs (hereinafter referred to as "pharmaceutical packages") national standards. The new standards will come into effect on 1 December 2015.
In accordance with the provisions of the Drug Administration Law of the People's Republic of China and its implementing regulations and the requirements of the 12th Five-Year Plan for National Drug Safety on "raising the standards for packaging materials for 139 directly-contact medicines", the General Administration of Food and Drug Administration revised and improved the existing standards for 139 pharmaceutical packages, consolidated and improved some of them, resulting in 130 national standards for pharmaceutical packages. The new standards have been greatly improved in terminology and quality control such as testing methods and testing limits, which are of positive significance for further promoting the construction of china's standard system for pharmaceutical packages, improving the quality of medicinal packages and medicines, promoting the development of the pharmaceutical package industry, and ensuring the safety and effectiveness of public drug use.
in order to facilitate public inquiry and use, strengthen the publicity of information, the release of 130 standard text of pharmaceutical packages has been all in the General Administration website and the Website of the Chinese Academy of Sciences public. (Food and Drug Administration website)