Answer： The current regulatory/normative requirements are as follows: ICH GCP (E6 R2) states that all clinical data intended to be submitted to the drug regulatory department should comply with GCP. Article 3 of Chapter 1 of the Chinese GCP states that "all clinical trials, human bioavailability or bioequivalence trials conducted in each phase must be carried out in accordance with this standard". Article 17 of the Drug Administration Law of the People's Republic of China (August 26, 2019) stipulates that "those engaged in drug development activities shall comply with the quality management standards for non clinical drug research and drug clinical trials, and ensure that the entire process of drug development continues to comply with legal requirements. The EU Regulation (No 536/2014) clearly states that non intervention studies are not applicable to this law. At present, China has not explicitly proposed regulations/guidelines for non-interventive research. However, based on the requirements of domestic GCP and drug management laws, as well as referring to the requirements of foreign regulations mentioned above, it is recommended that post market research used for registration applications must comply with GCP. Other types of post market research must also comply with the principles of GCP and the requirements of the Helsinki Declaration on Human Medical Research Ethics at the World Medical Congress. It is recommended that the company establish an SOP for post listing research and classify post listing research into categories (post listing registered research, post listing non registered research, or interventional or observational research) for management. The specific regulatory requirements refer to the following chapters (for reference): ICH GCP (E6 R2), indicated that 'This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities The principles established in this guideline may also be applied to other clinical investments that may have an impact on the safety and well being of human subjects