SQA Regulatory Surveillance Summary | Monthly Update 2024
SQA
FEBRUARY 26, 2024
China: National Medical Products Administration (NMPA) China Requires ANDAs Without Reference Drugs to Demonstrate Clinical Value, 17 October 2023 On 13 October 2023, the NMPA announced regulations on generic drug registration / Abbreviated New Drug Application (ANDA) with no Reference Listed Drugs (RLDs).
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