Technical Guide to Research on Change of Pharmaceutical Package material sits on regulatory difficulties and key points of implementation

On May 29, 2020, the official website of the China Pharmaceutical Packaging Association issued the Technical Guide for Research on Change of Pharmaceutical Packaging Materials (T/CNPPA 3009-2020), which was implemented on May 29, 2020, the date of publication, which was introduced in conjunction with the drug registration management methods and related norms, which the industry calls the first technical guide for research on change of pharmaceutical packaging materialsThis paper combs the difficulties of drug package material supervision and implementation key points, can be used for pharmaceutical package materials to provide change research of basic research ideas and basic evaluation principles, but also for pharmaceutical companies to carry out drug package change evaluation to provide referencePharmaceutical package products refer to the use of the same or similar production processes and materials, with the same or similar functions of products, including different models and specifications, is an indispensable part of the drug, it is accompanied by the production, circulation and use of drugs, so the pharmaceutical package material to ensure the safety and effectiveness of drugs play an important roleIn recent years, with China's drug reform, the corresponding regulatory model of pharmaceutical packaging materials is also undergoing great changes, China's drug package material supervision model is a process from scratch, constantly improve, step by step, from the drug packaging without any restrictions to the implementation of the licensing system of production enterprises, to the pharmaceutical packaging "registration management system", the current reform is "associated review and approval system." The "registration management system" emphasizes "independent declaration, separate review and approval" and "associated review and approval system" emphasizes "re-reporting, associated review and approval"In addition, the nature of the two is basically the same, that is, both require technical review and approvalSee the table below for comparisonTable 1 The comparison table of the original registration management system of China's pharmaceutical package materials and the associated review and approval system in the drug package material association review and approval system, the drug listing license holder is the first responsible person for product quality, but this does not mean that the responsibility of the pharmaceutical package production enterprises become smaller, in cooperation with the drug listing license holders to study and improve product quality, the role of pharmaceutical package production enterprises can not be left behindThe associated review and approval system provides cooperation and technical exchange opportunities for drug market license holders and pharmaceutical package manufacturers to better ensure drug quality and drug safety, in the process, the package material enterprises should also be responsible for the preparation enterprise, control the change of the pharmaceutical package material, and take scientific assessment measures with the preparation enterprise to avoid the change of the drug package material to the drug Bring about adverse effects, China's current pharmaceutical package materials small and scattered, insufficient quality awareness, the capacity of all parts of the package enterprises are not the same, and there are also scale deviations in local supervision, therefore, the national drug regulatory departments need to introduce a joint review system related to the supporting technical guidance documents, such as the introduction of the "pharmaceutical package materials change research technical guide." 1, how to classify the change of the package material? For changes to pharmaceutical packages, the Guide classifies changes into technical and non-technical changes(1) Non-technical changes are mainly changes in the registration information of pharmaceutical package materials, the specific items are as follows: (2) technical changes, mainly changes in production address, prescription process, quality standards, etc., the specific items are as follows: This article for technical change projects in accordance with the high-risk package materials and non-high-risk package materials should be carried out in a controlled interpretation, marking red represents high-risk packet materials, including generally used for use in the study of what changes should be carried out in the technical category Inhalation preparations, injections, eye preparations of the pharmaceutical package material; new materials, new structures, new uses of the drug package material, the State Food and Drug Administration in accordance with the monitoring data specific requirements of the supervision of the drug package material; labeled green as non-high-risk pharmaceutical package material; after the change of the research content of the number of research projects (the representative needs to study; - representatives can be exempted from research; 2, the production site change should carry out what changes to carry out research? 3What changes should be carried out on raw materials and formulations? 4What changes should be studied for changes in production processes and process control? 5What changes should be carried out in the study of quality standardchanges? 6, product packaging changes should carry out what changes to carry out research? 7What changes should be carried out in other technical types?