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RLD is an approved drug product to which new generic versions are compared to show that they are bioequivalent.
The reference listed drug refers to the control drug used for the consistency evaluation of the quality and efficacy of generic drug products, usually the object to be copied, such as the original drug or the same internationally recognized drug. The reference preparation should be a drug with scientific and reasonable prescription and processing technology, stable product quality, and definite curative effect.
The original drug refers to the first drug approved for marketing at home and abroad, and has complete and sufficient safety and effectiveness data as the basis for marketing.
Internationally recognized homogeneous drugs refer to generic drugs that have been approved for marketing in the European Union, the United States, and Japan and have obtained the status of reference preparations.
1. Selection and determination of RLD
2. Filing and publication of RLD
3. Apply for Import Drug Approval Document
4. Procurement of RLD
5. Handle the Imported Drug Customs Clearance Form
6. After paying the tax, RLD will be released and delivered to the customer
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