GENERAL, ECTD & HUMAN MEDICINES COMMUNICATION TO INDUSTRY

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
SAHPGL-HPA-05BAU Variations Communication,

2022 Sep

4pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication

2021 Oct

2Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration

2021 Jul

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

2021 Oct

2Downloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE

2021 Nov

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.17Communication to industry on the sartans-containing medicines

2020 Oct

2pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.18Communication to industry on ranitidine-containing medicines

2020 Oct

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.19Communication to industry on metformin-containing medicines

2020 Oct

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Communication to industry on Clones and Replicas

2020 Nov

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA03Priority Review Requests Communication

2022 Feb

2pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Payment of annual retention fees for registered products

2022 May

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Retention Fee Notification – 9 June 2022

2022 Jun

1, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
Communication on Medicines Registration Renewals Implementation Framework

2022 Nov

2, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

2022 Jun

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process,

2019 Oct

1pdfDownloadcommunication-to-industry expression-of-interestgeneral-ectd-human-medicines-guidelines
Missing Applications – Call to Industry

2022 Aug

1, , pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines information-technology
Extension on commentary period for Borderline Products Guideline

2022 Sep

1, pdfDownloadcommunication-to-industrycorporate general-ectd-human-medicines-guidelines
Over-arching: Good Review Practice Guide,

2022 Jun

1, pdfDownloadcommunication-to-industry guidecorporate general-ectd-human-medicines-guidelines
Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)

2022 Oct

1docxDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA07Certification Variation Screening – Type II Proprietary name change applications and TOA’s

2022 Oct

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Renewals Frequently Asked Questions (FAQs),

2022 Nov

1, , , pdfDownloadcommunication-to-industry faqbiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure

2022 Nov

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs

2022 Dec

2pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
HPA09Pre-registration veterinary medicines tracker guide

2022 Dec

1, pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines veterinary-medicines