XiaoyaowanMay 15, 2018
Tag: CFDA , Data Protection System , Chinese Innovative Drugs , protection term
The Office of CFDA has started to seek public opinions on Implementation Measures for Drug Trial Data Protection (Interim) on April 26, which is introduced to improve and implement the pharmaceutical product trial data protection system, promote pharmaceutical product innovation, improve accessibility of Chinese innovative drugs, and meet clinical drug use demand.
Data protection system—the intellectual property protection system in parallel with the patent system
As an intellectual property protection system in parallel with the pharmaceutical product patent system, the data protection system will not extend the term of pharmaceutical product patent protection but can provide the most basic market protection for pharmaceutical products without patent protection or with insufficient patent production, especially for the newly developed innovative drugs, with the ultimate aim to stimulate the innovation activities of pharmaceutical enterprises.
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数据保护制度 Data protection system |
专利保护制度 Patent protection system |
责任主体 Liability subject |
药品监管部门 Pharmaceutical product regulator |
专利局 Patent office |
保护对象 Object of protection |
生产者或销售者提交的自行取得且未披露的试验数据和其它数据 Acquired and undisclosed trial data and other data submitted by producers or sellers |
具备明确的创新性的化合物、用途、制剂、组合等 Compounds, uses, preparations, and combinations, etc. that are clearly innovative |
保护方式 Way of protection |
不允许注册申请中未经已获得许可的申请人同意使用或依赖其提交的数据 Not permitting the use of or reliance on the data submitted by licensed applicants in the registration applications without their consent |
禁止未经专利持有人许可的药品生产和销售 Prohibiting pharmaceutical production and sales without licensing of patent holders |
保护期限 Term of protection |
以上市申请获批日期为起点,通常为5-12年 Starting from the approval date of marketing application, generally of 5-12 years |
以专利申请提交日期为起点,提供20年的保护期 Starting from the patent application filing date, of 20 years |
The Hatch-Waxman Act offers 5-year data protection term for new chemical entities early in 1984, making the U.S. the world’s first country with pharmaceutical product data protection system.
The data protection system has been relatively perfect in the U.S. Firstly, FDA has clearly defined the scope of data protection that covers extensively, with data protection applicable to new chemical drugs, therapeutic biological products, and pharmaceutical products with new indications; secondly, in terms of way of protection, FDA adopts the mode of "not accepting, not approving", i.e., during the data protection term, relevant generic drug applications will not be accepted or approved after the acceptance, through which, FDA offers the marketing exclusivity to pharmaceutical products eligible for data protection. Like the U.S., the data protection system of the EU also adopts such way of protection.
Upgrading and implementation to help Chinese innovative drugs
As a part of joining WTO, China officially introduced the data protection system when promulgating the Regulations for the Implementation of the Drug Administration Law in 2002, based on which, the Measures for the Administration of Drug Registration revised in 2007 specifically defines the term and conditions of data protection. Data protection later gradually developed and evolved, and underwent specific data protection periods like pharmaceutical product administrative protection and new drug protection.
However, settings of previous regulations on data protection system have many problems during the actual operation, regulations basically rest on theory, and do not lead to the due effect in the specific implementation process.
Those problems mainly include that the scope of application of data protection is not clearly defined and too narrow, and the way of protection lacks operable mechanism, etc. For example, the object to offer 6-year trial data protection is described as pharmaceutical products that "contain new chemical ingredients", which is vague and does not include the biological drugs that are increasingly important at present.
CFDA issued Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Protecting Rights and Interests of Innovators (Draft for Comment) in 2017, with the content including improvement of data protection system, offering different protection terms to innovative drugs, rare disease drugs, and pediatric drugs, etc., showing that problems in old regulations are being gradually improved.
保护类别 Category of protection |
保护期限 Term of protection |
批准上市的创新药 Innovative drugs approved for marketing |
6年 6 years |
罕见病/儿童专用创新药 Innovative drugs for rare diseases/special for children |
10年 10 years |
罕见病/儿童专用改良新药 Improved new drugs for rare diseases/special for children |
3年 3 years |
治疗用生物制品创新药 Therapeutic biological innovative drugs |
10年 10 years |
挑战专利成功和境外已上市但境内首仿 Pharmaceutical products succeeding in patent challenge and marketed overseas but first imitated in China |
1.5年 1.5 years |
The Implementation Measures for Drug Trial Data Protection (Interim) ("Measures") for which CFDA has started to seek public opinions since April 26 is the upgrading and implementation of the Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Protecting Rights and Interests of Innovators (Draft for Comment) in 2017. The implementation of the above Measures will help Chinese innovative drugs develop and grow in the long run.
In terms of object of protection, the Measures defines that the objects of protection of pharmaceutical product trial data are innovative drugs, innovative therapeutic biological products, pharmaceutical products for rare diseases, pediatric drugs, and pharmaceutical products succeeded in patent challenge, etc., with the protection coverage further expanded.
保护类别 Category of protection |
保护期限 Term of protection |
中国境内获批上市的创新药 Innovative drugs approved for marketing in China |
6年 6 years |
创新治疗用生物制品 Innovative therapeutic biological products |
12年 12 years |
罕见病和儿童专用药 Rare disease drugs and pediatric drugs |
6年 6 years |
其它类别 Other categories |
视情况1-5年 1-5 years, as the case may be |
In terms of way of protection, the Measures defines that "during the protection term, without consent of the data protection right holder, the national drug administration shall not approve other applicants’ marketing applications for pharmaceutical products of the same variety, except that the applicants depend on trial data acquired by themselves or obtain the marketing authorization". Such way of "not approving" is in line with the current way of protection of the U.S. and EU.
Furthermore, in Article 10 (Technical Review) and Article 11 (Authorization Publicity), the Measures has corresponding provisions for the review procedure and publicity requirements, such as requiring simultaneous publicity of data protection information and pharmaceutical product approval information. Those measures are conductive to the implementation of the data protection system.
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