SA CORONA VIRUS WEBSITE

COVID-19 | SUBSCRIBE | FAQs

GENERAL, ECTD & HUMAN MEDICINES TEMPLATES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Notification Template 1 for Nitrosamine Risk Evaluation

2021 Dec

1docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
Notification Template 2 for Nitrosamine Confirmatory Testing

2021 Dec

1docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
Outcome of Risk for Nitrosamine Investigation

2021 Dec

1xlsxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eCTD

2020 Feb

1docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eSubmission

2020 Feb

1docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.16New Registration Validation Template for eCTD

2019 Jul

3docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.30New Registration Validation Template for eSubmission

2019 Jul

1docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.31Summary of Critical Regulatory Elements (SCoRE)

2020 Nov

3docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.32Bioequivalence Trial Information Form (BTIF)

2020 Nov

3docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.33Abridged review template

2019 Aug

2docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.34Verified review template

2019 Aug

2docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.38Additional Strength Biowaiver Application Form

2020 Nov

3docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.39Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form

2020 Nov

3docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines