Biological Medicines Guidelines

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines08/06/20234pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines24/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-05Biological Medicines Amendment guideline22/09/20225pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04Biological medicines stability Guideline18/08/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-03Guideline for Pre-Registration Consultation Meeting13/09/20222pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.30Biosimilar Medicines Guidance14/08/20203pdfDownloadguidelinebiological-medicines-evaluation-and-research