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Question: For other varieties that regulatory agencies require attention to, signal detection frequency should be increased. What are the types of products that regulatory authorities require to pay attention to, and is it the same definition as the evaluation conclusion of the PSUR report submitted to regulatory authorities, which is' concerned/not concerned '?
Answer: Article 57 of the "Quality Management Standards for Pharmacovigilance" states that the frequency of signal detection should be reasonably determined based on relevant factors such as drug launch time, drug characteristics, and risk characteristics. For newly launched innovative drugs, improved new drugs, and other varieties that require attention from provincial or higher drug regulatory departments or drug adverse reaction monitoring institutions, signal detection frequency should be increased. Other varieties that regulatory authorities require attention to may be drugs that have conditional approval for marketing; It can also be products that require companies to strengthen monitoring due to various safety considerations after being launched (such as discovering new safety issues with similar products, receiving public attention for product use, and monitoring results from monitoring agencies indicating drug risks). The evaluation conclusion of "paying attention/not paying attention" mentioned here is not the same as that of the PUSR report submitted to regulatory authorities. If the evaluation conclusion of the report in PSUR is "concerned", the enterprise needs to communicate with the teachers in the evaluation center in a timely manner, clarify the relevant requirements in the audit opinions, and handle and respond in a timely manner.