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Imported API: API No Longer Issues Approval Number

Date: 2019-04-13
浏览次数: 466

If the original auxiliary packaging obtains the approval certificate before the implementation of the relevant approval policies and continues to be used for formulation, it shall be transferred to the registration platform by the SDA, and the registration number shall be indicated.

The generic APIs that have been listed on the market in China may not be associated with pharmaceutical formulations when they are registered, that is, they are registered separately and reviewed independently. After review, the registration status is marked with 'A' and the registration status is marked with 'I'.。

If the drug is marked as 'A', it means that the drug has passed the examination and approval, but the drug approval number is no longer issued.

The pharmaceutical supervisory and administrative departments of each province shall strengthen the supervision and inspection of the pharmaceutical enterprises in their respective administrative regions, and urge the pharmaceutical enterprises to fulfill the auditing responsibilities of the suppliers of pharmaceutical auxiliary materials and pharmaceutical packaging materials.

The administrative license for pharmaceutical accessories and packaging materials has been cancelled, and there is no charge for platform registration.

This also means that APIs will no longer be on the agenda alone.


Earlier, in an interview with the media, experts said publicly that, in fact, when drafting documents, the state hoped that pharmaceutical enterprises could produce raw materials themselves in the future. What the State Administration requires is to realize the management and supervision of the whole industrial chain. If the API of the preparation Enterprise matches its own product and is the unified person in charge of the product, it will be encouraged from the regulatory level.

'In the future, the pharmaceutical industry will pay more attention to how pharmaceutical companies control the quality of raw materials, which will indeed pose a challenge to current pharmaceutical companies.'

It is generally believed that the recorded raw materials can be directly converted to DMF for filing when they are updated. Therefore, the mode of API industry will not change significantly, but it will enter the threshold of API industry later. Increased quality requirements.

API market will be more competitive

Obviously, breaking the monopoly of API is imminent.

Although the official document of the drug administration has not yet been released, the progress of the draft consultation is considered to be a system that will not wait too long to influence the changing methods of key raw materials in the pharmaceutical industry.

After the API is no longer issued with the approval number, the raw material manufacturers that have previously exported to Europe and the United States but applied for the approval of domestic API can now become API suppliers as long as they have passed the domestic GMP certification. In the future, imported air pollution index factories will also enter the market, and the competition in the air pollution index market will be more fierce.

Many insiders believe that one of the reasons for the current price monopoly lies to some extent in the approval system of API enterprises. Due to the scarcity of approval system, not all enterprises can produce.

Pharmaceutical companies are either forced to shut down or keep up with prices as the prices of APIs soar. The final victim is the patient. Industry insiders predict that the state will severely punish monopoly and open raw material examination and approval to solve the problem of monopoly of raw materials.

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