Hospital traditional Chinese medicine preparation needs record management

2018-02-13 health report liu zhiyong

On February 12, the state food and drug supervision and administration bureau issued "on the application of traditional process preparation traditional Chinese medicine preparations of medical institutions to implement the record management notice", to specifically granules made from Chinese medicine yinpian extracted by water and made from Chinese medicine yinpian after crushing the capsule, etc., application of traditional process preparation traditional Chinese medicine preparations of medical institutions a filing management; Traditional Chinese medicine preparations are limited to the use of medical institutions that have obtained the registration number of the variety of the preparation. They are generally not used for dispensing, and they need to be used for dispensing, and they are implemented according to relevant state regulations. No sales or disguised sales in the market shall be allowed, and advertisements for pharmaceutical preparations shall not be issued.

"Notice" the regulation of traditional Chinese medicine preparation including, by Chinese medicine yinpian after smashing or only extracted by water or oil made from solid (pill, powder, Dan, lozenge, etc.), half solid (zi, stickers, etc) and liquid (such as medicinal broth) traditional dosage forms; The granules made from the water extracted from the Chinese medicine yinpian and the capsules made from the Chinese medicine yinpian after being crushed; Traditional Chinese medicine is used to extract wine, tincture and so on. Medical institutions for the record by the traditional Chinese medicine preparation shall be specified in the "practice license of medical institution" with the diagnosis and treatment scope is consistent, and on the market for the supply of varieties of the same prescription different varieties of dosage form, traditional Chinese medicine formula particles may not be for the record.

State drug supervision administration, the provincial drug supervision department is responsible for establishing the information platform of traditional Chinese medicine preparation for the record, medical institutions should be through the local drug regulatory department at the provincial level for the record information platform, complete registration information given the name of the platform automatically open preparations, medical institutions, and for the record, the basic information of the traditional Chinese medicine preparation for the record, the internal control standards, the prescription of traditional Chinese medicine preparation for the record, auxiliary materials, process parameters, such as data will not be open. Preparation of traditional Chinese medicine medical organizations should obtain the pharmaceutical preparation certificate for medical institution, do not have aptitude can entrust a qualified units, but must at the same time to the local drug regulatory department at the provincial level for the record.

"Notice" pointed out that the traditional Chinese medicine prescription may not change, other information for the record shall not be arbitrarily changed, involved in traditional Chinese medicine, Chinese medicine yinpian, standard or specification etc information change, affecting the quality of preparation for medical institutions should be according to relevant procedures and requirements to the original registration department to register the changes. The medical institutions should further accumulate the validity data of clinical use, strictly perform the responsibility of adverse reaction reporting, and establish the adverse reaction monitoring and risk control system. The traditional Chinese medicine preparations that have obtained the approval number shall not be re-registered after the expiration of the approval number, and the record shall be filed according to the requirements of the record.