GENERAL, ECTD & HUMAN MEDICINES GUIDELINES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Industry Communication on Interim Measures Pending Update of Variation Addendum,

2020 Sep

1pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
2.01General information guideline

2019 Jul

10pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.02Quality and Bioequivalence

2019 Jul

7pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.08Variations Addendum for Human and Veterinary Medicines

2022 Feb

5, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
2.09Clinical guideline

2019 Jul

2, pdfDownloadguidelineclinical-trials general-ectd-human-medicines-guidelines
2.14Guideline for Patient Information Leaflet for Human Medicines

2019 Jul

2, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines health-products-authorisation
2.16Guideline for Professional Information for Human Medicines

2019 Jul

2, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines health-products-authorisation
2.22eCTD Validation Criteria

2016 Sep

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.23Guideline for submission in eCTD format

2019 Jul

3pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.58Submission in eSubmission format

2019 Jul

1pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.59Guideline for the APIMF Procedure

2021 Jan

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)

2022 Jun

2, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines section-21 unregistered-products
4.01SA Guide to Good Manufacturing Practice

2019 Jul

7, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices
5.08Reliance Guideline

2022 Mar

3pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.125BAU variations communication,

2022 Feb

3pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication

2021 Oct

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration

2021 Jul

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.129Re-submission of BAU New Medicines Applications from 2018 and 2019

2021 Oct

2pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
2.07Dissolution

2015 Jun

5pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines
9.132Priority Review Requests Communication,

2022 Feb

1pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-BIO-01Guideline for Lot release of human vaccines

2022 Apr

2, pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines
Communication on Medicines Registration Renewals Implementation Framework,

June 2022

1, , , pdfDownloadcommunication-to-industry guidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process

2022 Jun

1, , pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines veterinary-medicines