Biological Medicines Evaluation And Research Unit (BMERU) Guidelines

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
2.30Biosimilar Medicines Guidance

2014 Aug

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SAHPGL-PEM-BIO-03Guideline for Pre-Registration Consultation Meeting

2022 Sep

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04Biological medicines stability Guideline

2022 Aug

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-05Biological Medicines Amendment guideline

2022 Sep

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SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines

2022 Aug

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SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines

2022 Sep

3pdfDownloadguidelinebiological-medicines-evaluation-and-research