Recently, the China Food and Drug Administration ("CFDA") has drafted the Technical Guidelines for the Assessment of Traditional Chinese Medicine Resources (Draft for Comment) (the "Draft for Comment") for public comments by October 31, 2017.
The Draft for Comment states that drug manufacturers using medicinal material resources should provide materials to justify the balance between the estimated consumption of medicinal materials and the quantity of accessible medicinal material resources. According to the Draft for Comment, the assessment of traditional Chinese medicine resources mainly involves three aspects, such as the estimated consumption, potential risks and measures for ensuring the sustainable availability. In principle, the traditional Chinese medicine resources should be reevaluated every five years. In addition, the Draft for Comment clearly specifies that when a Chinese patent drug already launched on the market is re-registered, the manufacturer should evaluate the traditional Chinese medicine resources before the re-registration, provided that the prescription for this drug contains endangered wildlife medicinal materials and the corresponding medicinal material may be exhausted as a result of the production of this Chinese patent drug. For compound Chinese patent drugs, each type of medical herbs contained in the prescription should be assessed independently.