Biological Medicines Evaluation And Research Unit (BMERU) Guidelines

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	07/09/2022	3	Biological Medicines Evaluation and Research	pdf	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 Evaluation and Research	pdf	Download	guideline	biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-05	Biological Medicines Amendment guideline	Guideline	22/09/2022	5	Biological Medicines Evaluation and Research	pdf	Download	guideline	biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04	Biological medicines stability Guideline	Guideline	18/08/2022	2	Biological Medicines Evaluation and Research	pdf	Download	guideline	biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-03	Guideline for Pre-Registration Consultation Meeting	Guideline	13/09/2022	2	Biological Medicines Evaluation and Research	pdf	Download	guideline	biological-medicines-evaluation-and-research
2.30	Biosimilar Medicines Guidance	Guideline	22/08/2014	3	Biological Medicines Evaluation and Research		Download	guideline	biological-medicines-evaluation-and-research