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      Position and enforcement practice of the People’s Republic of China’s pharmaceutical data exclusivity protection

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          Abstract

          The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People’s Republic of China’s domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People’s Republic of China’s Drug Supervision Department, pharmaceutical data exclusivity protection has encountered some problems, including data authentication, exclusive rights to data, number of drugs requiring data to be submitted, and drug costs. In view of the long-term interests of the People’s Republic of China’s pharmaceutical industry and intellectual property protection trends, there are a lot of difficulties in the enforcement of pharmaceutical data exclusivity protection law that need to be overcome. Some measures can be taken, such as establishing a shorter data exclusivity protection period, only protecting the data submitted and relied on in the People’s Republic of China, only protecting the drugs that use new chemical components, allowing application and necessary research before the expiry of pharmaceutical data exclusivity protection period of generic drugs.

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          Most cited references 22

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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2016
                22 June 2016
                : 10
                : 2015-2020
                Affiliations
                [1 ]School of Law, Ningbo University, Ningbo, People’s Republic of China
                [2 ]School of Law and Politics, Ningbo Institute of Technology, Zhejiang University, Ningbo, People’s Republic of China
                [3 ]Center for Advanced Life Cycle Engineering, University of Maryland, College Park, MD, USA
                Author notes
                Correspondence: Xiang Yu, School of Law and Politics, Ningbo Institute of Technology, Zhejiang University, 1 Xuefu Rd, Yinzhou, Ningbo 315100, People’s Republic of China, Email nityuxiang@ 123456126.com
                Article
                dddt-10-2015
                10.2147/DDDT.S104642
                4922801
                27382254
                © 2016 Li et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Review

                Pharmacology & Pharmaceutical medicine

                competition, drug, developing countries, approval

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