A brief introduction to China's new Drug Administration Law and its impact on medications for rare diseases

被引：5
|
作者：
Wang, Yueqiang [1 ]
Chen, Duo [1 ]
He, Jiangjiang [1 ,2 ]
机构：
[1] Shanghai Med Informat Ctr, Shanghai Hlth Dev Res Ctr, 1477 Beijing W Rd, Shanghai 200040, Peoples R China
[2] Fudan Univ, Sch Publ Hlth, Shanghai, Peoples R China
来源：
INTRACTABLE & RARE DISEASES RESEARCH | 2019年 / 8卷 / 04期
关键词：
Drug Administration Law; characteristics of legislation; implementation of the law; rare disease; orphan drug;
D O I：
10.5582/irdr.2019.01133
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
The Drug Administration Law of the People's Republic of China (amended in August 2019) is a major piece of legislation governing drug administration in China. This law seeks to improve health legislation; to achieve this, it defines the concepts of fake drugs and inferior drugs and their differences, it emphasizes the regulation of reliability, it standardizes online drug sales, it encourages technological innovation, and it specifies legal liability and punishment through legislative amendments. The Drug Administration Law is characteristic of responsive legislation, and it guarantees a right to health for citizens. The law provides for priority review and approval of new drugs for diseases like rare diseases, it encourages the domestic manufacturing and development of new drugs for rare diseases, and it provides a firm legal basis for medications to treat rare diseases under the Healthy China strategy.
引用
收藏
页码：226 / 230
页数：5
相关论文
共 36 条
  • [1] CHINA NEW BANKRUPTCY LAW - A TRANSLATION AND BRIEF INTRODUCTION
    BOSHKOFF, DG
    SONG, YX
    [J]. AMERICAN BANKRUPTCY LAW JOURNAL, 1987, 61 (04): : 359 - 372
  • [2] DRUG ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA
    [J]. China's Foreign Trade, 2002, (06) : 19 - 27
  • [3] Release and impact of China's "Second List of Rare Diseases"
    Tang, Mi
    Yang, Yan
    Ye, Ziping
    Song, Peipei
    Jin, Chunlin
    Kang, Qi
    He, Jiangjiang
    [J]. INTRACTABLE & RARE DISEASES RESEARCH, 2023, 12 (04) : 251 - 256
  • [4] The impact of the Orphan Drug Act on Food and Drug Administration-approved therapies for rare skin diseases and skin-related cancers
    Karas, Laura
    Lu, Christine Y.
    Agrawal, Pankaj B.
    Asgari, Maryam M.
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2019, 81 (03) : 867 - 877
  • [5] Looking for a solution for drug addiction in China: Exploring the challenges and opportunities in the way of China's new Drug Control Law
    Liu, Yu
    Liang, Juncheng
    Zhao, Chengzheng
    Zhou, Wenhua
    [J]. INTERNATIONAL JOURNAL OF DRUG POLICY, 2010, 21 (03) : 149 - 154
  • [6] The impact of China's new Environmental Protection Law on corporate environmental investments
    Liu, Weiming
    Qiu, Yating
    Jia, Lijiang
    Wu, You
    Zhou, Qingmei
    [J]. FRONTIERS IN ENERGY RESEARCH, 2023, 11
  • [7] Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases
    Liu, Gumei
    Chen, Eric
    Lewis, Debra
    Rao, Gayatri
    [J]. JOURNAL OF MEDICAL DEVICES-TRANSACTIONS OF THE ASME, 2017, 11 (03):
  • [8] The Impact of China's New Environmental Law on the Financial Performance of Heavy Polluting Enterprises
    Jin, Xin
    Lei, Xue
    [J]. POLISH JOURNAL OF ENVIRONMENTAL STUDIES, 2024, 33 (04):
  • [9] Neglected tropical diseases in the genomics era: re-evaluating the impact of new drugs and mass drug administration
    Simon L. Croft
    [J]. Genome Biology, 17
  • [10] Neglected tropical diseases in the genomics era: re-evaluating the impact of new drugs and mass drug administration
    Croft, Simon L.
    [J]. GENOME BIOLOGY, 2016, 17
1234