‍‍‍‍TheState Drug Administration issued the "ancient classical Chinese medicinecompound preparation to simplify the registration and examination and approvalmanagement regulations", clear the classic name Prescription Applicationon the market, can only provide pharmaceutical and non-clinical safety researchdata, exempt from the pharmacodynamics research and clinical trial data.After the prescription is made intogranules, the registration and approval can be simplified according to therequirements.

The regulation also emphasizes that the drug supervision and administrationdepartment does not approve the reregistration of the classic name prescriptionwhich is not listed in the validity period of the approval number and cannotcarry out the drug quality, curative effect and the liability for adversereactions.The regulationsalso specify the scope of experts for the review, including pharmaceutical,medical and toxicology technicians.

Source:www.cntcm.com.cn

Time:2018.6.4‍‍‍‍