Document Number | Title | Categories | Date Updated | Version | Units | File Type | Link | doc_categories_hfilter | doc_tags_hfilter |
---|---|---|---|---|---|---|---|---|---|
SAHPGL-PEM-BIO-01 | Guideline for Lot Release of Human Vaccines | Guideline | 08/06/2023 | 4 | Biological Medicines | Download | guideline | biological-medicines-evaluation-and-research | |
SAHPGL-PEM-BIO-06 | General guidance document on QSE for Biological Medicines | Guideline | 24/08/2022 | 2 | Biological Medicines | Download | guideline | biological-medicines-evaluation-and-research | |
SAHPGL-PEM-BIO-05 | Biological Medicines Amendment guideline | Guideline | 22/09/2022 | 5 | Biological Medicines | Download | guideline | biological-medicines-evaluation-and-research | |
SAHPGL-PEM-BIO-04 | Biological medicines stability Guideline | Guideline | 18/08/2022 | 2 | Biological Medicines | Download | guideline | biological-medicines-evaluation-and-research | |
SAHPGL-PEM-BIO-03 | Guideline for Pre-Registration Consultation Meeting | Guideline | 13/09/2022 | 2 | Biological Medicines | Download | guideline | biological-medicines-evaluation-and-research | |
2.30 | Biosimilar Medicines Guidance | Guideline | 14/08/2020 | 3 | Biological Medicines | Download | guideline | biological-medicines-evaluation-and-research |