Question: ArrayHow will the sponsor communicate with regulatory agencies regarding important risks identified during risk signal testing during clinical trials? Email or applicant's window
Answer: According to the notice issued by CDE on April 26, 2019, regarding the submission of safety related reports during the opening of the drug evaluation center website during research and development, it is not an exception Quick reports of other potential serious safety risk information can be submitted electronically on the website of the Drug Evaluation Center of the National Drug Administration through the "Safety Related Reports during Research and Development Period" section of the applicant's window. According to the notice of "Good Practice for Safety Information Assessment and Management during Drug Clinical Trials (Trial)" (No. 5 of 2020) Article 2, Article 3, Article 4, and Article 17: During the clinical trial period, the applicant shall actively cooperate with relevant parties such as clinical trial institutions, and strictly implement the main responsibility of safety risk management. For safety risk issues that arise during clinical trials, applicants should promptly communicate and exchange relevant risk and management information through the website of the Drug Review Center, and report to the drug regulatory department. According to Article 127 of the "Quality Management Standards for Drug Vigilance", except for individual safety reports of expected serious adverse reactions, applicants should also make scientific judgments on other potential serious safety risk information and report to the national drug evaluation agency as soon as possible.