News center_News center_Rico International (Beijing) Medicine Technology Co., Ltd.

12-20 

Good news of signing the contract

On December 19th, 2022, Rico International (Beijing) Medicine Technology Co., Ltd. reached a strategic consensus with Japan's Ribomic Co., Ltd. and Shanghai Huirui Medical Devices Co., Ltd. on the clinical development of RBM-007 with age-related macular degeneration (AMD), and signed a tripartite joint venture company framework agreement to jointly promote the clinical development, promotion and sales of this drug in Greater China.

05-21 

How to understand the batch number and expiration date of drugs

According to the national regulations, except for Chinese herbal medicine and some Chinese herbal pieces, all finished drugs must be marked with the production batch number and the period of validity on their packages. Before purchasing and using drugs, the batch number and effective date should be carefully identified. The production batch number is the date of production of the drug, which generally uses six digits. The first two digits indicate the year, the middle two digits indicate the month, and the last two digits indicate the production batch number. If it is printed as "batch number: 060503", it means that the drug was produced in the third batch in May 2006. The term of validity refers to the approved service life of a drug, which means that the drug can guarantee its quality under certain storage conditions. The term of validity of a drug is a mark related to the stability and safety of the drug. According to the newly revised Drug Law of the people's Republic of China in 2001, it must be marked in the instructions. The period of validity of a drug is determined by a series of scientific experiments to observe the time when it can maintain its efficacy under certain storage conditions from the date of production. If the production batch number is 060503 and the validity period is two years, it means that the validity period of the drug can be up to May 31, 2008. The term of validity of a drug is expressed on its package in chronological order. It is generally expressed as the term of validity to a certain month or year, or expressed in numbers. If it is valid until October 2008, or it is marked as valid until October 2008, 2008 / 10, 2008-10, etc.

07-31 

Provisions for Post-marketing Changes of Drugs (Interim)

Article 1 [Objective] These Provisions are formulated for the purpose of further regulating post-marketing changes of drugs and strengthening administrative responsibilities of drug marketing authori

04-23 

Good Clinical Practice

　　Article 1 In order to ensure the standardization of drug clinical trial conduct, the scien- tific integrity, authenticity and reliability of data and results, and the protection of rights, safety

06-30 

Registration Classification and Requirements for Application Dossiers of Chemical Drugs

　I. Registration Classification of Chemical Drugs 　　The registration classification of chemical drugs includes innovative drugs, modified new drugs, generic drugs, and chemical drugs overseas markete

01-15 

Provisions for Bundling Review and Approval of Chemical Drug Substances, Pharmaceutical Excipients, Pharmaceutical Packaging Materials and Drug Product (Draft for Comments)

　　Article 1 (Basis & Purpose) In order to improve the quality and efficiency of drug registration and ensure the safety, effectiveness and quality controllability of drugs, the Provisions have been formulated in accordance with the “Drug Administration Law of The People’s Republic of China” and the “Drug Registration Regulation”.

10-16 

The registration classification and documents requirements of biological products

　Biological products are preparations that are manufactured from microorganisms, cells, animal- or human-derived tissues, body fluids etc. as starting raw materials making by biological technologies,

10-19 

“The requirements for application documents for selection of reference drug of generic chemical drugs” issued by CDE (No.32 2020)

　In order to better serve the applicants and further improve the quality and efficiency of the selection of reference drug, CDE has developed “The requirements for application documents for selection

03-15 

Provisions for Drug Insert Sheets and Labels

　　The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of J

01-15 

Information Supplement Procedure of the Center for Drug Evaluation

　　Article 1 To standardize the management of information supplement required during drug application review, clarify the basis and requirements for information supplement, and improve the quality and

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