Explaination of New Guideline for Post-approval Changes to Chemical Drug in Combination with the Post-approval Change Managements in China, the United States and Europe

被引：0
|
作者：
Zhang, Baomei [1 ]
Lu, Xiaojun [1 ]
机构：
[1] Center for Drug Evaluation, National Medical Products Administration, Beijing,100022, China
来源：
Chinese Journal of Pharmaceuticals | 2022年 / 53卷 / 07期
关键词：
D O I：
10.16522/j.cnki.cjph.2022.07.020
中图分类号：
学科分类号：
摘要：
7
引用
收藏
页码：1056 / 1061
相关论文
共 50 条
  • [21] Post-approval Change Submission: ICH Q12 Impact Analysis on India and Japan
    Moorkoth, S.
    Haldar, T.
    INDIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2020, 82 (01) : 2 - 10
  • [22] Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration
    Pinnow, Ellen
    Herz, Naomi
    Loyo-Berrios, Nilsa
    Tarver, Michelle
    JOURNAL OF WOMENS HEALTH, 2014, 23 (03) : 218 - 223
  • [23] Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database
    Ziyadeh, Najat J.
    Geldhof, Anja
    Noel, Wim
    Otero-Lobato, Marijo
    Esslinger, Suzan
    Chakravarty, Soumya D.
    Wang, Yiting
    Seeger, John D.
    CLINICAL DRUG INVESTIGATION, 2020, 40 (11) : 1021 - 1040
  • [24] Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database
    Najat J. Ziyadeh
    Anja Geldhof
    Wim Noël
    Marijo Otero-Lobato
    Suzan Esslinger
    Soumya D. Chakravarty
    Yiting Wang
    John D. Seeger
    Clinical Drug Investigation, 2020, 40 : 1021 - 1040
  • [25] Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks
    Bloem, Lourens T.
    Karomi, Mariana
    Hoekman, Jarno
    van der Elst, Menno E.
    Leufkens, Hubert G. M.
    Klungel, Olaf H.
    Mantel-Teeuwisse, Aukje K.
    EXPERT OPINION ON DRUG SAFETY, 2021, 20 (11) : 1433 - 1442
  • [26] The Role of Enhanced Analytical Procedure Development in Facilitating Post-Approval Changes Via Established Conditions
    Kirkpatrick, Douglas
    Gupta, Nirzari
    Gopalaswamy, Ramesh
    Kolhatkar, Rohit
    Hudson-Davis, Morgan
    Keire, David
    AAPS JOURNAL, 2025, 27 (02):
  • [27] Uptake of new drugs in the early post-approval period in the Mini-Sentinel distributed database
    Mott, Katrina
    Graham, David J.
    Toh, Sengwee
    Gagne, Joshua J.
    Levenson, Mark
    Ma, Yong
    Reichman, Marsha E.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2016, 25 (09) : 1023 - 1032
  • [28] Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition
    Tamura, Norio
    Ishiguro, Chieko
    Matsuda, Tsutomu
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2015, 24 (02) : 166 - 175
  • [29] Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019
    Alsamil, Ali M.
    Gardarsdottir, Helga
    Leufkens, Hubert G.
    Egberts, Toine C.
    Giezen, Thijs J.
    DRUG DISCOVERY TODAY, 2023, 28 (10)
  • [30] Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability
    Vinther, Anders
    Ramnarine, Emma
    Gastineau, Thierry
    O'Brien, Laura
    Brehm, Oliver
    Fryrear, David
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2024, 58 (03) : 433 - 442
12345