T/CNPPA 3019-2022 Active Group standards

T/CNPPA 3019-2022 Guidelines for the study of equivalence/substitutability and compatibility of drug packaging changes upon market launch

Publish Date: 2022-01-20 Implement Date: 2022-01-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CNPPA 3019-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Integrated services in the fields of medicine, health, and labor protection

ICS Name: Drugs

Publish Date: 2022-01-20

Implement Date: 2022-01-20

Scope

Main technical content: Packaging materials and containers are an integral part of medicines. Changes in packaging materials and containers may affect the physicochemical properties, impurity profiles, content, and stability of medicines. The risk depends on the drug's administration route, the performance of packaging materials and containers, and the interaction between packaging and formulations. Generally, changes to the packaging materials and containers of medicines should be beneficial to ensuring the quality of the medicines and should not adversely affect the quality of the medicines. Changes to the packaging materials or containers/packaging systems (hereinafter referred to as pharmaceutical packaging materials) of marketed medicines, as well as research and evaluation of changes occurring during the production process of pharmaceutical packaging materials, are important aspects of ensuring quality risk management throughout the entire life cycle of medicines for pharmaceutical manufacturers and pharmaceutical packaging material manufacturers. These are clearly stipulated in the Pharmaceutical Administration Law, the Pharmaceutical Registration Management Measures, and the Post-Marketing Changes Management Measures (Trial). The Technical Guidelines for Pharmaceutical Changes Research of Marketed Chemical Drugs issued by the National Medical Products Administration's Drug Evaluation Center require that when medium and major changes occur in pharmaceutical packaging materials, "a comparative study of the relevant characteristics of packaging materials and containers before and after the changes should be conducted, and an equivalence/substitutability study of pharmaceutical packaging materials should be carried out". The Technical Guidelines for Pharmaceutical Packaging Material Changes Research issued by the China Pharmaceutical Packaging Association (T/CNPPA 3009-2020) propose that "the pharmaceutical product marketing authorization holders and pharmaceuti