South African Health Products Regulatory Authority (Nitrosamines)

South African Health Products Regulatory Authority (SAHPRA) posted a guidance document relevant for application for renewal of registration or marketing authorization of both human and veterinary medicinal products.

Section A. Annual Product Quality Review (PQRI)

A declaration that the risk assessment for applications registered without nitrosamine risk assessment has been done and the necessary updates have been submitted

IDRAC_348646_17-Jun-2022_Guideline SAHPGL-HPA-04_ Submission of Renewals for Human and Veterinary Me.pdf (280.2 KB)


Nitrosamine-SAHPRA.pdf (1.1 MB)
SAHPRA, South Africa has released the final guidance on NITROSAMINE COMMUNICATION (enclosed) and is largely in line with the EMA and FDA guidances. Nitrosamines limits are adopted from EMA Q&A documents.

Some additional flexibilities are listed below:

  • Applicants can submit variations to their API and/or FPP (e.g. manufacturing process, controls and specifications, product formulation, raw materials and packaging) during the pre-registration phase if nitrosamines are detected above acceptable intake limits.

  • Acceptability of less than life time approach on case by case basis with SAHPRA consultation and well defined treatment duration adjusted AI limits.

  • SAHPRA also accepts limits approved by authorities which it aligns itself with.

Happy reading!

Thanks & regards,

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