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SAHPRA’s Biological Medicines Amendment Guideline - A Critical Update for Biologic Product Sponsors
The South African Health Products Regulatory Authority (SAHPRA) has released the sixth version of its Biological Medicines Amendment...
Sharan Murugan
Jun 72 min read
15 views
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South Africa SAHPRA's Med Dev Guidance: Updated Q&A-Guide to Licensing Medical Device Establishments
In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and...
Sharan Murugan
May 242 min read
12 views
0 comments
SAHPRA Guideline: Section 21 Access to Unregistered Medicines
The South African Health Products Regulatory Authority (SAHPRA)Â has updated its Guideline " Section 21 Access to Unregistered Medicines "...
Sharan Murugan
Apr 63 min read
80 views
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SAHPRA Regulatory Information Management System (RIMS): Cancellation of Health Product Registrations for Non-eCTDs
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry " Regulatory Information...
Sharan Murugan
Mar 162 min read
28 views
0 comments
SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA)Â has released an updated " Guideline for the Classification of Medical...
Sharan Murugan
Mar 12 min read
76 views
0 comments
SAHPRA South Africa: Renewal of the Certificate of Registration - Fee Schedule and Explanatory Notes
The South African Health Products Regulatory Authority (SAHPRA)Â has updated its " Fee Schedule and Explanatory Notes " Â to renew human...
Sharan Murugan
Feb 192 min read
39 views
0 comments
South Africa's SAHPRA: Renewal Process for Human -A Comprehensive Guide
The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of...
Sharan Murugan
Feb 122 min read
55 views
0 comments
South Africs's SAHPRA Guidance: on Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA)Â has issued comprehensive guidelines to streamline the reporting of...
Sharan Murugan
Jan 263 min read
17 views
0 comments
South Africs's SAHPRA Communication: Regulatory Information Management System – Application Withdrawal
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry on the process for the...
Sharan Murugan
Jan 262 min read
23 views
0 comments
SAHPRA's: Guidelines for Medical Device Adverse Event Reporting
The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting...
Sharan Murugan
Dec 15, 20242 min read
32 views
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South Africa's SAHPRA: Communication to Industry on Quality Variations
The SAHPRA released a " Communication to Industry on Quality Variations "Â document that addresses updates on the submission requirements...
Sharan Murugan
Nov 11, 20242 min read
39 views
0 comments
South Africa-SAHPRA: Engagement Portal
As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we launched the SAHPRA Engagement...
Sharan Murugan
Nov 9, 20242 min read
31 views
0 comments
SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...
Sharan Murugan
Oct 27, 20242 min read
57 views
0 comments
South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...
Sharan Murugan
Sep 9, 20242 min read
67 views
0 comments
SAPHRA Guidance: Guideline On Co-Applicancy
The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...
Sharan Murugan
Jul 20, 20241 min read
15 views
0 comments
South Africa (SAPHRA): Reliance Guideline
Recently this week the South African Health Products Regulatory Authority (SAHPRA) has updated the Reliance Guideline to streamline the...
Sharan Murugan
May 18, 20242 min read
70 views
0 comments
South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...
Sharan Murugan
Mar 30, 20242 min read
73 views
0 comments
South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline "Guidelines For Medicine...
Sharan Murugan
Feb 22, 20242 min read
56 views
0 comments
South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation
Earlier today (16 January, 2024) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline For...
Sharan Murugan
Jan 16, 20241 min read
18 views
0 comments
South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On...
Sharan Murugan
Nov 19, 20231 min read
40 views
0 comments