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API is no longer issued separately, and the symbol DMF is ready to come out.

API is no longer issued separately, and the symbol DMF is ready to come out.

作者:taziadmin    来源:未知    发布时间:2018-11-07 14:25    浏览量:
Recently, 36 articles of "two offices" clearly put forward that the examination and approval of drugs and pharmaceutical raw materials and excipients and packaging materials should be carried out. That is to say, APIs are examined and approved at the same time when the application for drug registration is approved, and the approval number of APIs is no longer issued. The APIs and their quality standards which have been related to the evaluation are published on the designated platform for relevant enterprises to choose.

Some enterprises have also been puzzled about the future development of API. Xu Xiping, chairman of Shenzhen Osa Pharmaceutical Co., Ltd., mentioned that the raw material of a product produced by his company was 600 yuan per kilogram ten years ago, and it has risen to 6000 yuan in recent ten years. "So the company intends to produce its own APIs. At present, it has just built a API factory and intends to provide its own APIs. It does not need the original cooperative enterprises. It is not clear how the specific linkages are related to the"related approval"proposed by the state.

Song Ruilin, executive chairman of China Association for the Promotion of Medical Innovation, has his own explanation: "In fact, when drafting documents, the National Bureau hopes that pharmaceutical enterprises can produce their own raw materials in the future. The National Bureau requires the management and supervision of the whole industry chain. Pharmaceutical raw materials of pharmaceutical enterprises, if they are compatible with their own products, are the unified responsible persons for the products and are encouraged from the regulatory level. In the future, the industry will pay more attention to how pharmaceutical companies control APIs, which will indeed bring challenges to the current APIs enterprises.

At the same time, different opinions in the industry blend, in addition to estimating that pharmaceutical enterprises produce their own APIs, there are more worries about intensifying the monopoly of APIs. "In fact, whether pharmaceutical enterprises produce their own APIs is a commercial consideration, and the production of APIs also requires human and material resources. In addition, the industry structure will not change much, because the main responsibility is always pharmaceutical enterprises, but the threshold to enter the API industry will rise with the improvement of quality requirements.

In the view of industry insiders, with the possible implementation of DMF system in China in the future, raw materials and their quality standards, which have been related to the review, are publicized on designated platforms for relevant enterprises to choose. It can even be assumed that the original number of APIs may also be directly converted to DMF when renewal, so the pattern of APIs industry will not change significantly.

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