Guidelines on Procedures and Data Requirements for Changes to Approved Biotherapeutic Products

Update: 24 November, 2023

The document provides guidelines on procedures and data requirements for changes to approved biotherapeutic products.

File format: PDF

Size: 383 KB

MD5 Checksum: AA5C793F05D8DF742D3ACD7AB713D5F8

Publication date: 24 November, 2023

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