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What is a reference formulation? Which enterprises need reference formulation?

Date: 2020-01-09
浏览次数: 46

1、 What is reference formulation?


Reference formulation refers to the reference drug used for the consistency evaluation of quality and efficacy of generic drugs, which is usually the object to be imitated, such as the original drug or internationally recognized drug of the same kind. The reference formulation should be a drug with reasonable prescription, stable quality and definite curative effect.


The original research drug refers to the first drug allowed to be listed at home and abroad, with complete and sufficient safety and effectiveness data as the basis for listing.


The internationally recognized generic drugs refer to the generic drugs that are licensed by the European Union, the United States and Japan and have the status of reference formulation.


2、 Which companies need to buy reference formulations?


1). Generic manufacturer

2). Generic R & D institutions


The evaluation objectives include: domestic generic drugs, imported generic drugs and original research drugs.


3、 Purchasing process of reference formulation


1. Selection and determination of reference formulation

2. Filing and release of reference formulation

3. Application for Approval of Imported Drugs

4. preparation for purchasing reference formulation

5. Handling the Customs Clearance Form for Imported Drugs

6. Release goods to customers after tax payment


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