Our country plans to be put on record and managed the original adjuvants of pharmaceutial use

Our country plans to be put on record and managed the original adjuvants of pharmaceutial use
Our country plans to be put on record and managed the original adjuvants of pharmaceutial use
It is reported ' Reporter Wang LeMin) Our country plans to be put on record and managed the original adjuvants of pharmaceutial use. On September 20, national food medicines supervise the administration bureau announcing on their official sites <>,Begin to solicit the opinion publicly. At present, most adopt registering and examining and approving the management system to the original auxiliary materials of pharmaceutial use in our country. Among them, raw materials medicine, powder bag material all adopt and register and examine and approve and release the authentication code, adopt and register, examine and approve traditional Chinese medicine extract and adjuvants part and release the authentication code. After putting on record the management system, "every raw materials medicine that have already sanctioned listing medicines preparation, traditional Chinese medicine extract, medical adjuvants, original auxiliary materials exposed to packing materials of medicines and container directly need to be put on record " . Draft stipulate medicines original production firm of adjuvants should put on record information at the platform in the intersection of pharmaceuticals administration and the intersection of pharmaceutial use and original auxiliary materials that department set up, submit original auxiliary materials relevant information as requested. The original auxiliary materials that the medicines manufacturer uses should be put on record information and remained unanimity all the time with the original auxiliary materials, if is inconsistent, should be voluntarily out of use. National food medicines supervise the relevant person of administration bureau introducing, implement the original auxiliary materials filing system of pharmaceutial use, further define the medicines manufacturing enterprise and relation and their own responsibility for producing enterprise of original auxiliary materials in main purpose. This system is clear, the first person liable in product quality is preparation enterprises, the aspect of practical operation of should be choosing former auxiliary materials and supplier and auditinging etc. has the responsibility. Meanwhile, the filing system also emphasized the authenticity that the former auxiliary materials manufacturing enterprise of pharmaceutial use is put on record the materials to the original auxiliary materials has the responsibility.


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