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Biological Medicines Evaluation And Research Unit (BMERU) Guidelines

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

2021 May

1Downloadguidelinebiological-medicines-evaluation-and-research
2.30Biosimilar Medicines Guidance

2014 Aug

3Downloadguidelinebiological-medicines-evaluation-and-research
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

5pdfDownloadguidelinebiological-medicines-evaluation-and-research
6.20Pre-Registration Consultation Meeting Material Checklist

2014 Jun

1Downloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines

2022 Aug

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines

2022 Sep

3pdfDownloadguidelinebiological-medicines-evaluation-and-research
Communication on Medicines Registration Renewals Implementation Framework,

2022 Jun

1, , , pdfDownloadcommunication-to-industry guidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines