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12-17

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The National Medical Products Administration’s Announcement on the Release of Requirements for Management of Pharmaceutical Records and Data

To implement the relevant provisions of the Drug Administration Law and the Vaccine Administration Law, strengthen the recording and data management of drug research and development, production, distribution, and use activities, and ensure that the relevant information is authentic, accurate, complete, and traceable, the National Medical Products Administration has organized the formulation of the “Requirements for Drug Records and Data Management (Trial Implementation).” These requirements are hereby promulgated and shall take effect as of December 1, 2020.

The National Medical Products Administration’s Announcement on the Release of Requirements for Management of Pharmaceutical Records and Data

12-17

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Administrative Measures for Drug Operation Licenses

(Promulgated by Order No. 6 of the State Food and Drug Administration on February 4, 2004; amended according to the “Decision on Amending Certain Regulations” adopted at the Bureau Meeting of the National Medical Products Administration on November 7, 2017)

Administrative Measures for Drug Operation Licenses

12-16

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Measures for the Supervision and Administration of Pharmaceutical Production

The “Measures for the Supervision and Administration of Pharmaceutical Production” were reviewed and approved at the 1st Bureau Meeting of the State Administration for Market Regulation on January 15, 2020. They are now promulgated and shall take effect as of July 1, 2020.

Measures for the Supervision and Administration of Pharmaceutical Production

12-16

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Notice Regarding Matters Concerning the Certificate of Pharmaceutical Product Approval (CPP) for Marketing Authorization

Given the FDA’s adjustment to its policy on CPP documents, it is agreed that for FDA-approved drugs exported from countries other than the United States, the CPP document will no longer be required when filing a registration application in China. Instead, applicants may submit a screenshot of the FDA website or other supporting documentation to substantiate the information provided in the registration application.

Notice Regarding Matters Concerning the Certificate of Pharmaceutical Product Approval (CPP) for Marketing Authorization

11-25

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Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Issuance of the “Procedures for Supplementing Information by the Center for Drug Evaluation (Trial)” (No. 42 of 2020)

To support the implementation of the “Measures for Drug Registration Management” and further standardize the management of supplementary materials in drug registration review and approval, and drawing on the research findings from the drug review process-oriented scientific management system as well as the practical experience of review work, the Center for Drug Evaluation has developed and issued the “Procedures for Supplementary Materials Work at the Center for Drug Evaluation (Trial).”

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Issuance of the “Procedures for Supplementing Information by the Center for Drug Evaluation (Trial)” (No. 42 of 2020)

10-09

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Announcement by the National Medical Products Administration on the Release of the Guiding Principles for Quality Agreements for Contract Manufacturing of Pharmaceuticals (2020 Edition) (No. 107 of 2020)

To implement the relevant provisions of the Drug Administration Law and further strengthen the supervision and management of drug production, the National Medical Products Administration has developed the “Guidelines for Quality Agreements on Contract Manufacturing of Drugs (2020 Edition),” which are intended to guide and supervise marketing authorization holders and contract manufacturing enterprises in fulfilling their obligations to ensure drug quality. These guidelines are hereby released and shall take effect from the date of their publication.

Announcement by the National Medical Products Administration on the Release of the Guiding Principles for Quality Agreements for Contract Manufacturing of Pharmaceuticals (2020 Edition) (No. 107 of 2020)

03-30

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Drug Registration Management Measures

The “Administrative Measures for Drug Registration” were reviewed and approved at the 1st Bureau Meeting of the State Administration for Market Regulation on January 15, 2020, and are hereby promulgated and shall take effect as of July 1, 2020.

Drug Registration Management Measures

12-20

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Notice of the National Medical Products Administration on the Issuance of Guiding Principles for Conditional Approval of Medical Devices for Market Launch (No. 93 of 2019)

To implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, address clinical treatment needs for serious life-threatening diseases, and accelerate the review and approval process for relevant medical devices, the National Medical Products Administration has developed the Guiding Principles for Conditional Approval of Medical Devices for Market Launch (see attachment). These principles are hereby released.

Notice of the National Medical Products Administration on the Issuance of Guiding Principles for Conditional Approval of Medical Devices for Market Launch (No. 93 of 2019)

07-30

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Regulations on the Management of Medical Device Instructions and Labels

The “Regulations on the Management of Instructions for Medical Devices and Labels” were reviewed and adopted at the Bureau Meeting of the State Administration for Food and Drug Administration on June 27, 2014. They are hereby promulgated and shall take effect as of October 1, 2014.

Regulations on the Management of Medical Device Instructions and Labels

07-30

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Medical Device Registration and Management Measures

The “Administrative Measures for the Registration of Medical Devices” were reviewed and approved at the Bureau Meeting of the State Administration for Food and Drug Administration on June 27, 2014. They are hereby promulgated and shall take effect as of October 1, 2014.

Medical Device Registration and Management Measures
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Rico International (Beijing) Medicine Technology Co., Ltd.

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Address: Room 905A, Building B, East Zone, Jianwai SOHO, No. 39, Middle Section of East Third Ring Road, Chaoyang District, Beijing

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