On July 29, CFDA announced a notice that related to strengthen supervision and management in the production of traditional Chinese medicine extraction. The file specified: proprietary Chinese medicine production enterprise outsourcing Chinese medicine extract raw materials is prohibited. And demanded that traditional Chinese medicine factory should have extraction ability of corresponding to the varieties and scale of production.

 

OEM processing mode has been stopped

Introduction of new regulations directly make the raw material OEM processing mode gradually become history in the traditional Chinese medicine factory production for many years. According industry veteran told to Herbridge Media, most of the pharmaceutical companies have not enough capacity to processing Chinese medicinal materials, as well as some specific plant varieties require special processing techniques, those are need to delegate some plant extract factory to complete. And the new rules to some extent also limited the plant extract factory who can provide special technology processing continue to service for pharmaceutical plant.

 

 

The two "stop without exception” will to interdict plant extracts into the pharmaceutical industry

 

The two "stop without exception”:

The CFDA shall stop the examination and approval of traditional Chinese medicine extraction processing, for approved, it will be valid until December 31, 2015. The proprietary Chinese medicine production enterprises whoever does not have Chinese traditional medicine extraction ability shall stop the corresponding varieties of production since the date of January 1, 2016.

Some Chinese plant extracts production enterprises are actively applying for CFDA certification of GMP factory in order to improve the control ability of enterprise in the field of raw materials, to gain the qualification of pharmaceutical grade raw materials processing and to establish business cooperation with traditional Chinese medicine factory, according Herbridge Media. And some enterprises basically take such cooperation as the only model of business support. The new rule means that, the production enterprises that originally provide the powder or herbal extracts to the traditional Chinese medicine factory have to seek other development.

 

 

The new health food laws may make reference to the new rules

 

Zhang Jinjing, supervising officer of health food and cosmetics of CFDA told to Herbridge Media, said that: the new health food law is possible to learning from the new regulations of production of traditional Chinese medicines extracts. In addition, it is planned that “the food safety law" of industry widely attention can finish second and third approval in August and October respectively. But due to solicit opinions from the more, the CFDA as far as possible taken enterprise and industry factors into account. Thus, it is expected to make a second approval until October, The new health food laws will also be implemented and published after “the food safety law” new rules come out completely.