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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)

11-10

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Bringing global pharmaceutical and healthcare products and technologies to China,

Rico International (Beijing) Medicine Technology Co., Ltd. was established in 2020. It is composed of a group of accomplished and highly contributing pharmaceutical experts, scholars, and business management professionals in the pharmaceutical and healthcare fields. The company aims to assist domestic and international pharmaceutical enterprises in product introduction, technology acquisition, and market expansion; to bring global pharmaceutical and healthcare products and technologies into China, enabling Chinese consumers to access cutting-edge and high-quality medicines from around the world, thereby benefiting the Chinese people; and at the same time, to export Chinese pharmaceutical and healthcare products and technologies to overseas counterparts, benefiting all humanity.

Bringing global pharmaceutical and healthcare products and technologies to China,

11-10

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Export Chinese pharmaceutical and healthcare products and technologies to international counterparts, benefiting all of humanity.

Rico International (Beijing) Medicine Technology Co., Ltd. was established in 2020. It is composed of a group of accomplished and highly contributing pharmaceutical experts, scholars, and business management professionals in the pharmaceutical and healthcare fields. The company aims to assist domestic and international pharmaceutical enterprises in product introduction, technology acquisition, and market expansion; to bring global pharmaceutical and healthcare products and technologies into China, enabling Chinese consumers to access cutting-edge and high-quality medicines from around the world, thereby benefiting the Chinese people; and at the same time, to export Chinese pharmaceutical and healthcare products and technologies to overseas counterparts, benefiting all humanity.

Export Chinese pharmaceutical and healthcare products and technologies to international counterparts, benefiting all of humanity.

11-10

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Aimed at supporting domestic and international pharmaceutical companies in product introduction, technology acquisition, and market expansion.

Rico International (Beijing) Medicine Technology Co., Ltd. was established in 2020. It is composed of a group of accomplished and highly contributing pharmaceutical experts, scholars, and business management professionals in the pharmaceutical and healthcare fields. The company aims to assist domestic and international pharmaceutical enterprises in product introduction, technology acquisition, and market expansion; to bring global pharmaceutical and healthcare products and technologies into China, enabling Chinese consumers to access cutting-edge and high-quality medicines from around the world, thereby benefiting the Chinese people; and at the same time, to export Chinese pharmaceutical and healthcare products and technologies to overseas counterparts, benefiting all humanity.

Aimed at supporting domestic and international pharmaceutical companies in product introduction, technology acquisition, and market expansion.

11-10

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Rico International (Beijing) Medicine Technology Co., Ltd. was established in 2020.

Rico International (Beijing) Medicine Technology Co., Ltd. was established in 2020. It is composed of a group of accomplished and highly contributing pharmaceutical experts, scholars, and business management professionals in the pharmaceutical and healthcare fields. The company aims to assist domestic and international pharmaceutical enterprises in product introduction, technology acquisition, and market expansion; to bring global pharmaceutical and healthcare products and technologies into China, enabling Chinese consumers to access cutting-edge and high-quality medicines from around the world, thereby benefiting the Chinese people; and at the same time, to export Chinese pharmaceutical and healthcare products and technologies to overseas counterparts, benefiting all humanity.

Rico International (Beijing) Medicine Technology Co., Ltd. was established in 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
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Rico International (Beijing) Medicine Technology Co., Ltd.

Tel: +86-10-53329998

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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