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New Product Filings to date

Variations and Agency Responses filed to date

Shortest time (months) to SAHPRA approval for New Medicine

SAHPRA office closure during festive season29 November 2023, 3:11 pm
SAHPRA offices will be closed for the festive season from 12:00 on Friday, 22 December 2023 and will re-open on Tuesday, 02 January 2024. Submissions to SAHPRA New Medicine, Variation, License, Renewal Applications Applications/submissions must reach SAHPRA by 14 December 2023 at 13:00 to allow... The post SAHPRA office closure during festive seaso...
SAHPRA encourages reporting side effects this MedSafetyWeek6 November 2023, 5:16 pm
Pretoria, 06 November 2023 – The South African Health Products Regulatory Authority (SAHPRA) is urging patients, doctors, nurses, or pharmacists to play their part in reporting side effects using the MedSafety app. Reporting side effects is key to helping make medicines safer for the population... The post SAHPRA encourages reporting side eff...

Medical Device Code overhaul1 December 2023, 1:08 pm
Reasonable hospitality and travel for healthcare professionals (HCPs) and company-organised educational events are just three of 37 provisions covered by the Medical Device Code which have been updated and strengthened. SAMED, led by the Code Committee, undertook an extensive review of the Code over the last few months to close out gaps, align with...
2023 highlights through the lens of our strategic pillars1 December 2023, 10:47 am
Thank you, SAMED members, for playing active roles in the numerous and diverse initiatives which SAMED pursued this year in order to achieve our objectives and elevate medtech. PROGRESS OUTPUTS Safeguarding, promoting and representing members’ common interests Developing a health product regulatory qualification [...] The post 2023...