Recently, the China Food and Drug Administration ("CFDA") has formulated and issued the Technical Guidelines for Researches into Changes to Production Techniques of Traditional Chinese Medicine ("TCM") Already Launched on the Market (the "Guidelines").
The Guidelines expressly state that changes to production techniques of existing TCM on the market are classified into three categories. Changes of Category I are minor ones, impossible to cause any effect on the substance essentials for the medical use or result in significant impacts on the absorption and functioning of drugs. Changes of Category II refer to moderate ones, having possible but not major influences on the substance essentials for the medical use or on the absorption and functioning of drugs. However, changes of Category III are considered as drastic, resulting in either obvious impacts on the substance essentials for the medical use or potential significant impacts on the absorption and functioning of drugs. Despite changes of any kind, no negative effects are allowed on the safety and effectiveness of drugs. An applicant, as the subject mainly responsible for researches into possible changes, should make studies in consideration of characteristics of its products and in accordance with basic requirements specified in the Guidelines and applicable provisions on the administration of drug registration.