The State Council has issued a document indicating that protected varieties of traditional Chinese medicine will receive greater attention in the future!
Date：2018/9/29
On September 28, the State Council issued the "Decision of the State Council on Amending Certain Administrative Regulations," stating that after reviewing administrative regulations related to institutional reforms, the State Council decided to amend certain provisions of 10 administrative regulations.
One notable amendment is the revision of Article 4 of the "Regulations on the Protection of Traditional Chinese Medicine Varieties" to read: "The State Council's drug regulatory department is responsible for the supervision and management of the protection of traditional Chinese medicine varieties nationwide." The phrase "drug production and operation authorities and health administrative departments" in the first paragraph of Article 13 has been changed to "drug regulatory department." This implies that the supervision and management of the protection of traditional Chinese medicine varieties in my country will be more centralized, with potentially greater oversight and efficiency. Furthermore, the production conditions for enterprises producing protected traditional Chinese medicine varieties will be more stringent. The document requires enterprises to possess a "Certificate of Protection for Traditional Chinese Medicine Varieties," and applications for the same variety will require quality inspection. Those failing to meet the standards will face the risk of having their approval revoked. Article 18 is amended to read: "If a traditional Chinese medicine variety approved for protection by the State Council's drug regulatory department was produced by multiple enterprises before approval, those enterprises that did not apply for the 'Certificate of Protected Traditional Chinese Medicine Variety' shall, within six months from the date of the announcement, submit an application to the State Council's drug regulatory department and provide relevant materials in accordance with Article 10 of these Regulations. The State Council's drug regulatory department shall designate a drug testing institution to conduct quality testing on the applied variety.
Based on the test results, if the variety meets the national drug standards, a 'Certificate of Protected Traditional Chinese Medicine Variety' shall be reissued; if it does not meet the national drug standards, the approval number for the traditional Chinese medicine variety shall be revoked in accordance with the laws and administrative regulations governing drug administration." Article 19 is amended to read: "The generic production of protected traditional Chinese medicine varieties that are in short supply for clinical use must be approved by the State Council's drug regulatory department and issued an approval number. The generic production enterprise shall pay a reasonable usage fee to the enterprise holding the 'Certificate of Protected Traditional Chinese Medicine Variety' and transferring the prescription composition and manufacturing process of the traditional Chinese medicine variety. The amount shall be agreed upon by both parties; if the parties cannot reach an agreement, the State Council's drug regulatory department shall adjudicate." "It is evident that whether it's the generic production of clinically scarce protected traditional Chinese medicines or the production of ordinary protected traditional Chinese medicines, enterprises must hold a 'Certificate for Protected Traditional Chinese Medicine Varieties' to operate. This also reflects my country's increasing emphasis on protected traditional Chinese medicine varieties and its stricter supervision of their safety. Furthermore, the document sets clear requirements for the production conditions of manufacturing enterprises. Article 20 has been amended to: 'Enterprises producing protected traditional Chinese medicine varieties shall, in accordance with the requirements put forward by the drug supervision and management departments of the provincial, autonomous region, and municipal governments, improve production conditions and enhance the quality of their varieties.' According to industry data, as of now, among nearly 165,000 drugs in my country, only 265 are listed as protected traditional Chinese medicine varieties, of which 51 varieties had their protection period terminated last year. This means that only 214 varieties are currently under protection. It is clear that my country's protected traditional Chinese medicine varieties are very scarce and possess a significant competitive advantage. The document issued by the State Council this time clearly demonstrates its emphasis on and support for protected traditional Chinese medicine varieties."
306, Building 10, Haier Zhigu, No. 66 Guangfulin East Road,
Zhongshan Street, Songjiang District, Shanghai
+86-21-57863517
+86 18221277621(WhatsApp)
+86-21-57863517