Article 1 In order to standardize the drug regulatory data protection (hereinafter referred to as data protection), this Working Procedure is hereby formulated in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for Implementation of the Drug Administration Law of the People's Republic of China, the Provisions for Drug Registration, and the Implementation Measures for Drug Regulatory Data Protection (hereinafter referred to as the Implementation Measures).

Article 2 The Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as CDE), under the guidance of the National Medical Products Administration (hereinafter referred to as NMPA), shall be responsible for the specific implementation of data protection.

When accepting a marketing registration application for chemical drugs and biological products, the data protection application submitted by the drug registration applicant (hereinafter referred to as the applicant) shall be reviewed concurrently. The review shall determine whether data protection should be granted.

During the data protection period, when accepting a marketing registration application or supplementary application that relies on the protected data of another marketing authorization holder (hereinafter referred to as the holder), the relevant information of the protected data being relied upon shall be concurrently reviewed. If, upon completion of the technical review, the protected data being relied upon are still within the protection period and the holder has not consented to such reliance, the review shall be suspended.

Article 3 The applicant applying for data protection shall submit the data protection application together with the marketing registration application, truthfully complete the relevant information in the application form, and specify the data protection period. The applicant shall be responsible for the authenticity of the data protection information submitted.

Article 4 Upon acceptance of a drug marketing registration application, the CDE shall concurrently conduct a formal review of the data protection application submitted by the applicant and mark the variety after acceptance.

Article 5 The CDE shall review applications for drug regulatory data protection during the review process in accordance with the relevant requirements of the Implementation Measures. For those meeting the requirements, a recommendation on the protection period to be granted shall be put forth, and the data protection period shall be specified. For those failing to meet the requirements, a recommendation not to grant data protection shall be made.

Article 6 For the varieties that are provided with data protection when approved for marketing, the CDE shall disclose the data protection-related contents approved in the registration approval documents in the special column of varieties under drug regulatory data protection.

Article 7 After a drug has obtained data protection, other applicants may submit marketing registration applications or supplementary applications for drugs relying on the protected data within one year prior to the expiration of the data protection period. When the applicants obtain the study data by themselves or rely on the protected data with the consent of the holders, they may directly submit the drug marketing registration applications or supplementary applications. Where the applicants rely on the protected data with the consent of the holders, they shall provide the Agreement on Consent to Drug Regulatory Data Reliance signed by both parties.

When submitting the drug marketing registration applications or supplementary applications, the applicants shall specify related information on whether they are relying on protected data in the application forms and specify each of them separately for those relying on the protected data of multiple varieties.

Article 8 When accepting drug marketing registration applications or supplementary applications, the CDE shall simultaneously conduct a formal review of related information submitted by applicants on whether they rely on protected data and mark the applications after acceptance.

Article 9 When CDE completes the technical review, if the protected data relied upon are still within the data protection period and the applicants fail to obtain the consent of the holders of protected data, the data protection period shall be indicated, the review shall be suspended, and the reasons for suspension shall be “drug regulatory data protection”.

Article 10 Beginning on the 14th working day prior to the expiration of the data protection period, varieties for which review was previously suspended on account of the data protection shall be resumed.

Article 11 Where data protection is terminated, the CDE shall update related information in the special column of varieties under drug regulatory data protection. From the date on which the NMPA issues the announcement on termination of data protection, the CDE may accept drug marketing registration applications and supplementary applications submitted by other applicants in reliance on the protected data. The review of the varieties previously suspended due to involvement in the protected data shall be resumed.

Article 12 The applicants may communicate with the CDE on issues related to data protection before submitting the drug marketing registration applications or supplementary applications or during the review in accordance with the requirements of the Measures for the Administration of Drug Research and Development and Technical Review Communication of the Center for Drug Evaluation of the National Medical Products Administration.

Article 13 For new issues and controversial issues encountered during the implementation of data protection, the CDE shall promptly organize study, and communicate with applicants when necessary. For issues that cannot be resolved by CDE shall be promptly submitted to the NMPA for study.

Article 14 The Working Procedure shall take effect as of the date of public release.