1. The focus is on how to present clinical trial data in accordance with GCP requirements;
  2. The challenge is that there is no data on Chinese populations, is there any data available after the product has been launched in Japan? If so, the data from Japan's launch and from Boao can be added to "3.4 Clinical Experience Data (Post-Market Follow-up Study)".
请翻译:1重点是怎么按照GCP要求呈现临床试验数据; 2难点是没有中国人群数据日本已上市之后有没有数据?如果有日本已上市数据和博鳌的数据可以增加到34 临床经验数据上市后随访研究

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