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.
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,
Sumit
1 Like
Hi everyone, not a new update (dated 15 May 2024), however I did not find any other post on this across the forum + in case useful…
SAHPRA provided update on Nitrosamines via communicatiion to stakeholders dated 15/May/2024 "“Nitrosamine communication (Issue No.: PEM01-2024/25)”
→ https://www.sahpra.org.za/wp-content/uploads/2024/05/Communication-to-Industry-on-Nitrosamine-Review-15-May-2024.pdf
Update is extended timelines, as follow:
Step 1: Risk assessment to be done for all products → from to 31 Dec 2023 to 31 December 2025
Step 2: Products with potential risk of nitrosamine impurities to submit confirmatory results → from 01 Dec 2024 to 01 Dec 2026
Step 3: Deadline for applying any necessary variation (if applicable) → from 01 Jul 2025 to 1 July 2027
Greetings from Germany 
4 Likes