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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

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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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

In addition, raw materials and finished products were found without identification, and with no means to verify the identity and origin of the products, which included a diverse array of vegetable drugs and many irregular products and labels stored in the inspected establishments. For a list of the products seized, click here.

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