State council revises regulations on the protection of traditional Chinese medicine varieties

The drug administration department is responsible for the protection and supervision of traditional Chinese medicine varieties

Time: 2018-10-08

Recently, promulgated by the state council on amending part of the decision of the administrative regulations, the regulations on the protection of TCM variety made several changes, the original more provisions in the regulations of "the health administration department under the state council" changed to "the pharmaceutical supervisory and administrative department under the state council", explicitly by the pharmaceutical supervisory and administrative department under the state council is responsible for the supervision and administration of the national protection of TCM variety.

This modification has been cancelled to apply for in the regulations of the protection of TCM variety of programs to be transferred as prescribed by the administrative department of health, at the same level changed to "to the local people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative department, by the people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative department of the first trial after signing, reported to the pharmaceutical supervisory and administrative department under the state council. Under special circumstances, traditional Chinese medicine manufacturers may also apply directly to the drug regulatory authority under the state council. At the same time, the responsibility of entrusting the review committee for the protection of traditional Chinese medicine varieties, organizing the review committee for the protection of traditional Chinese medicine varieties, and employing experts of traditional Chinese medicine as members of the committee will be entrusted to the drug regulatory department under the state council.

In addition, the regulations on the imitation of protected varieties of traditional Chinese medicine have been adjusted. Article 19 of the regulations is amended to read: "the imitation of protected varieties of traditional Chinese medicines in shortage of clinical medication shall be approved by the drug regulatory authority under the state council and the approval document number shall be issued. The imitation enterprise shall pay reasonable royalties to the enterprise that holds the certificate of protected variety of traditional Chinese medicine and transfers the prescription composition and process method of the traditional Chinese medicine variety, the amount of which shall be agreed by both parties. If the parties fail to reach an agreement, the drug regulatory authority under the state council shall make a ruling.