FDA是如何审评和批准仿制药的

是仿制药，另外有哪些基本要求。

What's Involved in Reviewing and Approving Generic Drug Applications?审评和批准仿制药，主要考虑什么？

下面这段不重要，也可以看看，主要看下面黄色背影部分

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Generic drugs are copies that one company makes of a brand-name drug that was developed by another company.  仿制药，其实就是个copy。如此形象。

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Generally, generic drugs sell at lower prices, and it is in the public's interest to get generic drugs to the market quickly.  But, like any other scientific and regulatory process, approval of a generic drug takes time.  It takes FDA time to review the complex information needed to demonstrate that a given generic drug can be substituted for the brand-name drug that it copies, and that time also depends on the complexity of the drug product and the completeness of the application.  Here is why:

Prescription drugs have significant, sometimes life-saving, positive effects, but they also may present significant risks.  FDA approves a drug only after review of extensive testing showing that a drug will provide the benefits described in its labeling, and that those outweigh its risks.

As a copy of the brand-name drug FDA originally reviewed, a generic drug application submitted to FDA for approval must show that:

The generic drug is "pharmaceutically equivalent" to the brand.仿制药与原研/参比是药学等效的。

The generic drug needs to show that it is the same type of product (such as a tablet or an injectable) and uses the same time release technology (such as immediate-release, meaning for immediate effect of the drug, or extended-release, meaning one that is intended to slowly release the active ingredient over time).

点评：相同剂型，相同释放时间的技术，说白了，例如万艾可（伟哥），你不能搞成迟释吧。

3 U; G% Q+ c' c2 K' w& \The manufacturer is capable of making the drug correctly.生产商有正确生产药品的能力。

Often different companies are involved (such as one company manufacturing the active ingredient and another company manufacturing the finished drug). Generic drug manufacturers must produce batches of the drugs they want to market and provide information about the manufacturing of those batches for FDA to review.

点评：一句话，别搞错了。

The manufacturer is capable of making the drug consistently.生产商有连续生产药品的能力。

Generic drug manufacturers must explain how they intend to manufacture the drug, and provide evidence that each step of the manufacturing process will produce the same result each time. FDA scientists review those procedures and FDA inspectors go to the generic drug manufacturer’s facility to verify that the manufacturer is capable of making the drug consistently and to check that the information the manufacturer has submitted to FDA is accurate.  

点评：要能够持续正确生产啊，申报工艺跟实际工艺要一致啊。别学某些企业。

The “active ingredient” is the same as that of the brand.仿制药与原研/参比具有相同的活性成分。

An active ingredient in a medicine is the component that makes it pharmaceutically active - effective against the illness or condition it is treating. Generic drug companies must provide evidence that shows that their active ingredient is the same as that of the brand-name drug they copy, and FDA must review that evidence.

点评：这点都搞错，就不要做药了。以前国内的那些奶粉厂家，可以关门了。

The right amount of the active ingredient gets to the place in the body where it has effect.正确剂量的活性成分到达作用部位。

Two drug products with the same amount of active ingredient may be processed differently for different people. Generic drug companies must perform studies that show that the same amount of drug gets to the bloodstream and that it gets there at about the same time. FDA scientists analyze the results to be sure the generic will produce the same result as the brand-name drug.

点评：也就是生物等效性了。

The "inactive" ingredients of the drug are safe.非活性成分是安全的。

Some differences, which must be shown to have no effect on how the drug functions, are allowed between the generic drug and the brand. Generic drug companies must submit evidence that all the ingredients used in their products are safe, and FDA must review that evidence.

点评：毒胶囊万万不可。

The drug does not break down over time.药品是稳定性。

Most drugs break down, or deteriorate, over time. Brand-name and generic drug companies must do months-long "stability tests" to show that their versions last for a reasonable time. FDA reviews the results of these studies.

点评：毕竟药品不是从工厂出来就到了患者嘴里。稳定性，必须的啊。

The container in which the drug will be shipped and sold is appropriate.运输和销售药品的容器是合适的。

The quality of the drug can deteriorate if its container is not appropriate. Information must be submitted about the containers and FDA must evaluate the information.

点评：记得以前，小纸袋分装药品，到了家里都被挤成粉了啊。遇到下雨，发现药都没了。囧啊。

The label is the same as the brand-name drug’s label.说明书跟原研/参比是相同的

The drug information label for the generic drugs should be the same as the brand. Sometimes, disputes arise related to the patents or exclusivities a brand-name drug has and which ones generic drugs can use. A generic drug can be approved for a use that is not protected by patents or legal exclusivities, and must remove all references to the legally protected use from the drug’s label, so long as that removal does not take away information needed for safe use.

点评：这点小编认为，灰常有必要，国内需要好好学习。说明书不同，可能会误操作，带来严重后果。

Relevant patents or legal exclusivities are expired.不存在专利或法律纠纷。

As an incentive to develop new drugs, drug companies are awarded patents and legal exclusivities that delay the FDA approval of applications for generic drugs. FDA must comply with the delays in review and approval that the patents and exclusivities impose.

点评：一句话，我们是法制社会啊。人家公司也是花了钱研发的，如果都瞎搞，谁还去努力提高研发水平，做新药呢。

本文摘自FDA 官网