The 52nd article of the Law on Drug Administration of the People's Republic of China stipulates that "the packaging materials and containers for direct contact with drugs must conform to medicinal requirements and safety standards." The 44th article of the regulations on the Enforcement of Drug Administration law of the People's Republic of China stipulates that: "The management methods, catalogues and medicinal requirements and standards of the packaging materials and containers for direct contact with drugs shall be formulated and promulgated by the Drug regulatory Department of the State Council." According to the above-mentioned laws and regulations, the state Drug Administration has formulated and promulgated 113 drug packaging Containers (materials) standards (including 2004 plan release standards) in batches since 2002, including standard 43 for medicinal glass bottle packaging Containers (materials), The standard quantity accounted for 38% of the total of all drug-covered villages, and the standard range covered the medicinal glass bottle packaging containers used for injection powder injections, water injections, infusion agents, tablets, pills, oral liquid and lyophilized, vaccines, blood products and other dosage forms. Has preliminarily formed a relatively perfect, standardized system of medicinal glass bottles.
The formulation and implementation of these standards, for medicinal glass bottle packaging container replacement, improve product quality, ensure drug quality, speed up with international standards and the world market, promote and standardize the Chinese pharmaceutical glass industry healthy, orderly and rapid development, has a pivotal significance and role. Medicinal glass bottles are direct contact with drug packaging materials, in the field of pharmaceutical packaging materials occupy a large proportion, and has irreplaceable performance and advantages, its standards for drug packaging quality and industry development has a vital impact.