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    Home > Medical News > Latest Medical News > The measures for change management after the drug is listed for public consultation.

    The measures for change management after the drug is listed for public consultation.

    • Last Update: 2020-08-05
    • Source: Internet
    • Author: User
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    On August 3rd, the State Drug Administration made public comments on the Measures for the Administration of Changes after Drug Market (Trial) (Draft for Comments) (hereinafter referred to as the Draft for Comments), the full text of which is referred to in the annex at the end of the text.
    This is China's first specific ally after the drug market change management set the normative document, China's drug after the market supervision work and regulate the drug market license holders after the drug market change behavior put forward more systematic, standardized requirements.
    the Draft of Comments clearly encourages holders to use new drug production management methods and production technologies to continuously improve the quality of drugs policy guidance, refine the new revised Drug Administration Law on the drug market changes based on risk classification management concept, emphasizing the drug market licensing holders must fully study and verify the technical changes after the drug market, enhance the coordination of China's drug market after the change management and international advanced practices, fully reflect the strengthening of post-event supervision and deepening of the "release of the regulatory" reform requirements.
    to encourage holders to carry out change research holders after the drug market to continuously introduce new technology and new methods to enhance drug safety, effectiveness and quality control is an inevitable requirement of scientific development, the resulting drug market changes throughout the various links and stages of drug production.
    the implementation of scientific management for drug market changes is conducive to the establishment and continuous improvement of the quality control system of drug life cycle.
    , the newly revised Drug Administration Law emphasizes that the change determination should be based on the substantive impact and the degree of risk to implement scientific management, further clarify that the change should not adversely affect the safety, effectiveness and quality control of the drug, and strengthen the holder's main position as the first person responsible for the change after the drug is listed.
    the newly revised Measures for the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production, respectively, make clear requirements for changing the matters or contents contained in the drug approval documents and annexes, and on the matters of changing the licensing and registration of drug production licenses.
    the draft for comments, the relevant requirements of the new revised Drug Administration Law and the Measures for the Administration of Drug Registration and The Measures for the Supervision and Administration of Drug Production should be implemented on the initiative, and that holders should take the initiative to carry out post-marketing research on drugs and realize the full life cycle management of drugs after listing;
    follow the principles of change control and classification management The Draft for Comments clearly states that changes should follow the principles of change control and classification management.
    the holder to fulfill the main responsibility of change management, the determination of the change category is mainly based on the holder's judgment on the change risk level;
    in the principle of change control, the holder is the responsible subject of change management after drug market, and should establish a post-marketing change control system in accordance with the relevant requirements of drug supervision laws and regulations and drug production quality management norms; in
    draft for comments, it is stated that changes to the market of drugs shall not adversely affect or pose potential risks to the safety, effectiveness and quality control of pharmaceuticals.
    In the principle of classification management, the change management category is divided into major changes, medium changes and minor changes, respectively, in accordance with the relevant provisions approved, after the implementation or reporting, the holder is responsible for the authenticity, accuracy and completeness of the submitted information.
    change management category can be dynamically adjusted change is based on scientific research and scientific cognition, with the continuous improvement of production management level and production technology, the determination of the same change situation category will be different at different times;
    , the Draft for Comments makes it clear that the holder may make adjustments to the change management category according to the change of management and production technology, and shall implement or report on the newly determined change management category after approval, filing.
    , if the change management category has a clear requirement in the law or regulation or technical guidelines, the holder shall generally determine the change category in accordance with the relevant provisions. where
    change circumstances do not specify the change management category in the legal, regulatory or technical guidelines, the holder shall determine the change category in accordance with the internal change classification principles, working procedures and risk management criteria, in the light of product characteristics and research and validation results, and by reference to the relevant technical guidelines. if the
    holder is unable to determine the change management category or the change management management category to be adjusted to be specified in the Guiding Principles, it may be implemented in accordance with the regulations after communicating and reaching agreement with the pharmaceutical regulatory authorities on the basis of adequate research and validation.
    refine the holder change procedure " Draft for Comments" to refine the holder change procedure, so that the market elements really flow up.
    the Draft for Comments, it is clear that if the name of the holder is changed, the record-keeping management shall be implemented. The scope of the
    includes changes such as the name of the holder, the name of the production address, the number of the door plate and the name of the entrusted production unit, and the holder shall, after completing the change of the corresponding matters of the drug production license, file a record with the local provincial drug regulatory department for the change of the relevant management information on the drug approval document;
    for changes in the holder's subject, the Draft for Comments stipulates that the transferee shall first obtain a drug production license for the corresponding production range and submit to the drug review center a supplementary application for registration without technical review. The working time limit for
    is 20 working days.
    the Draft for Comments, it is also proposed that the altered holder should have a production quality management system that meets the requirements of the quality management norms for pharmaceutical production, and that the drugs can be listed for sale only after inspection. After the change of the
    holder, the production site, prescription, production process and quality standard of the drug shall be consistent with the original drug. If
    changes occur, the holder shall conduct full research and verification and implement or report in accordance with the provisions upon approval, filing or reporting, so as to ensure the continuous and stable production of products consistent with the quality of the original medicine.
    clarify the site change and registration change "Draft for comments" to clarify the relevant circumstances of site change, further clarify the relationship between site change and registration matters change, while allowing the same holder to produce in multiple sites, stressed that after the completion of the site change, the holder must complete the site change may have to fully study and verify the impact of the change on the quality of the drug;
    the Draft for Comments, it is clear that the change of drug production site refers to the change of the address, location and production unit of the production site (including its own production site, the trustee's production site) as specified in the holder's drug production license and the drug approval document, including the original site or relocation, construction, alteration and expansion of the workshop or production line. if the
    to make a change in the production site, the holder shall apply to the provincial drug regulatory department in the place where it is located.
    the change of the drug production site, the prescription of the drug, production process technology, quality standards, etc. should be consistent with the original drug, and ensure that the consistent production of products consistent with the quality of the original drug.
    If there is a change, it shall conduct research and implement or report in accordance with the provisions of these Measures for approval, filing or reporting.
    process changes in accordance with the risk implementation of the classification management "draft for comments", it is proposed to carry out key production equipment, important raw materials and package material sources and types, key production link technical parameters, such as the change of the production process, the holder shall fully assess the size of the change may affect the safety, effectiveness and quality control of the drug, in accordance with the relevant technical guidelines and drug production quality management norms for full study and verification, determine the change management category, after approval, after filing implementation or report.
    .
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