The draft of the National People's Congress (NPC) retrial method of traditional Chinese medicine: a Chinese medicine preparation responsibility tracing system

14:48:54 August 31, 2016

Source: the rule of law in China

The standing committee of the National People's Congress on August 30, continue to review the traditional Chinese medicine of the People's Republic of China law (draft) "(hereinafter referred to as the law (draft) of traditional Chinese medicine), have members in the group, review of TCM preparation institution or person's name, the name shall be marked to establish responsibility tracing system in the field of traditional Chinese medicine preparation, in order to increase the effectiveness of the regulation, in the event of a problem to" out ".

On December 27, 2015, the 18th session of the twelfth session of the standing committee of the National People's Congress law (draft) of traditional Chinese medicine for the first time for consideration. In December 30 to January 29, 2016, the standing committee of the National People's Congress announced by the Chinese net law (draft) of traditional Chinese medicine, solicit the public opinions, article 32487 of the opinions received 13290 Internet users and 65 letters.

According to surging news monitoring, law (draft) of article 30 of traditional Chinese medicine, the state shall encourage medical institutions according to the needs of clinical medicine preparation and use of Chinese medicine preparations... .. A medical institution shall entrust the compound Chinese medicine preparation, to the local people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative departments for the record.

Strict to new members, said the second sentence should be changed to "Chinese medicine agent must indicate the compound name or names of those responsible, entrust a compound preparation of traditional Chinese medicine, should also indicate the name of the client and the client organization or person name, in the local administration of traditional Chinese medicine for the record, and accept the supervision and inspection."

"Indicate the mixture of TCM and agency or person name may establish responsibility tracing system in the field of traditional Chinese medicine preparation." Strict to the new thought, which can not only strengthen the responsibility consciousness of the preparation, guarantee the quality of dispensing drugs and curative effect, also can increase the effectiveness of the regulation, if problems arise out to the end.

In addition, the terms of the final rule is also, medical institutions responsible for the quality of the preparation of traditional Chinese medicine preparation; Entrust the compound preparation of traditional Chinese medicine, the principal and the entrusted party to the quality of the preparation of traditional Chinese medicine preparation bear corresponding responsibility.

Any liability, "said yan with the new" should be changed to "jointly and severally liable. "In the draft corresponding responsibility and connotation of expression is not clear, is not conducive to the division of specific responsibilities." Strict to the new analysis, points out that the client and the client as a Chinese medicine preparation of common responsibility, should be taken as a whole of pharmaceutical preparations dispensed by the joint responsibility, any one obligor has an obligation to the possible quality problems or damage responsibility.

Deputy to the National People's Congress Xu Dongxiang proposed at the same time, as Chinese medicine yinpian, the use of traditional Chinese medicine preparation, and manager, also need to be responsible for the medical institutions, sales of Chinese medicine yinpian, take full responsibility for the Chinese native medicine preparation and so on, including the rational drug use and storage, etc., not just only responsible for the quality.