The state administration of food and drug administration issued a notice on the administration of archival administration of traditional Chinese medicine

2018-02-14 Chinese traditional Chinese medicine (TCM) 1 version of qin yulong

On February 12, the state food and drug supervision and administration bureau released about the application of traditional process preparation traditional Chinese medicine preparations of medical institutions to implement the announcement of filing management (full version), for the record management of traditional Chinese medicine preparation work put forward specific requirements, and make detailed instructions for filing management process.

Announcement to implement method of traditional Chinese medicine and the pharmaceutical administration law of the People's Republic of China, the application of traditional process preparation ready for medical institutions of Chinese native medicine preparation for the record management and promote its healthy and orderly development.

Announcement, points out that medical institutions should strictly demonstrates LiTi basis of TCM and scientific nature, rationality and necessity, and the preparation of traditional Chinese medicine preparation to implement the whole process of quality management, safe and effective overall responsibility to preparation. In addition, the name of the traditional Chinese medicine preparation, instruction and label shall conform to the preparation of medical institution "registration management measure (trial)" the relevant provisions of the manual and label you should indicate the name of traditional Chinese medicine preparation, registration number, name of a medical institution, dispensing unit name, etc.

Announcement stressed that traditional Chinese medicine prescription may not change, other information for the record shall not be arbitrarily changed, the traditional Chinese medicine preparation has been put on record, with traditional Chinese medicine, Chinese medicine yinpian, standard or specification etc information change, affecting the quality of preparations of medical institutions shall apply to the original registration department to register the changes.

At the request of the announcement, provincial food and drug supervision and administration departments are responsible for the establishment of the traditional Chinese medicine preparation information platform. The platform automatically discloses the basic information of traditional Chinese medicine preparation, including the traditional Chinese medicine preparation name, medical institution name and so on. The standard, prescription, auxiliary materials and process parameters of the traditional Chinese medicine preparation are not disclosed.

The announcement made the regulation of the dosage forms included in traditional Chinese medicine preparations, made specific instructions to the record management process, and introduced the special cases such as the cancellation of the record and the non-filing.